[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"attention-deficit-hyperactivity-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:attention-deficit-hyperactivity-disorder":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,47,0,25,[9,53,65,103,131,163,188,215,237,261,287,307,327,360,389,437,465,491,517,538,564,593,622,647,675],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100054178","psychotherapy-for-irritability-in-youth-comparing-active-treatment-to-nonactive-psychoeducation-supportive-psychotherapy-100054178",false,"NCT07640802","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy","Psychotherapy for Irritability in Youth: Comparing Active Treatment to Non-Active Psychoeducation Supportive Psychotherapy","* INCLUSION CRITERIA FOR YOUTH\n\n  1. Age 8-16.5 years\n  2. Caregiver and\u002For child reports irritability as a primary clinical concern. Specifically, compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that manifests verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and\u002For precipitating event), verbal rages, and\u002For aggression toward people or property.\n\n  2a. Such events occur, on average, at least three times a week.\n\n  2b. This irritability is impairing in at least two of three domains (home, school, peers)\n\n  3\\. Patients must be fluent in English\n\n  3a. Participants must be able to speak and read English. This study evaluates English language, manualized psychotherapies. The intervention materials, therapist and rater training and supervision procedures, fidelity ratings, and primary outcome measure are\n\ncurrently available and validated only in English. Because psychotherapy relies on nuanced verbal exchange, use of translation or interpreters could alter treatment content, affect therapeutic alliance, compromise fidelity, and limit accurate clinical risk assessment. Examining fidelity and alliance\u002Fsupport are our primary and secondary objective in this study. Therefore, enrolling non-English speakers can introduce a confound to these research questions. Restricting enrollment to English-speaking participants is therefore necessary to ensure participant safety and scientific validity in this trial. Critically, this eligibility criterion is based solely on the language requirements of the intervention and study procedures and is not intended to exclude participants on the basis of race or ethnicity or any other factors.\n\n4\\. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his\u002Fher current treatment is no more than minimal (i.e. CGI-S of 3 or more).\n\n5\\. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment.\n\nINCLUSION CRITERIA FOR PARENT\n\n1. Parent of a child eligible for this protocol that can attend 12 parent sessions\n2. Fluent in English\n\nEXCLUSION CRITERIA\n\nParticipants will be screened to exclude participants who would not be able to engage in psychotherapy.\n\n1. Active major depressive disorder or history of psychosis, bipolar I disorder, Level 2 or 3 autism spectrum disorder, active severe substance use disorders (within the last month), conduct disorder, have active suicidal intent or plan as detected on screening instruments.\n2. IQ \\\u003C 70\n3. Past or present medical or neurological condition, disease, disorder, genetic finding, or injury that, in the opinion of the Investigator, may significantly increase the potential risks of study participation, reduce or compromise a subject s ability to fully comply with all study requirements for the duration of the study or may compromise the integrity of the data.\n\nEXCLUSION CRITERIA FOR PARENTS\n\n1. IQ \\\u003C 70\n2. Have any serious medical, mental health, or any condition that interferes with participation, such as active psychosis.\n3. Current alcohol or substance use or dependence (excluding nicotine) within the past 3 months of sufficient magnitude to require independent, concurrent treatment intervention (e.g. Antabuse or opiate treatment but not including self-help groups).","ALL","8 Years","17 Years",{"count":21,"type":22},300,"ESTIMATED","OBSERVATIONAL","Background:\n\nIrritability is defined as proneness to anger that may impair a person s ability to function. It is a common reason for why some children need mental health care. Yet no therapies have been developed just to target irritability. Researchers want to compare different types of therapy for irritability.\n\nObjective:\n\nTo test different types of therapy for children and teens with severe irritability.\n\nEligibility:\n\nPeople aged 8 to 16.5 years with severe irritability. Their parents are also needed.\n\nDesign:\n\nParticipants will have 28 study visits in 18 months.\n\nThey will have a baseline visit. They will answer questions about their mood, behavior, and daily life.\n\nAll parents and children will have 12 therapy sessions. Sessions will be once a week; they will last 30 to 60 minutes. Some of the child sessions may be done by telehealth.\n\nEach parent and child will have 1 of 3 therapy types:\n\nExposure therapy (child). Participants will face things that make them angry. A therapist will help them practice managing their anger.\n\nManagement therapy (parent). Therapists will coach parents on ways to manage their child s behaviors.\n\nPsychoeducation\u002Fsupportive psychotherapy (child and\u002For parent). Participants will talk with therapists about their or their child s feelings and behaviors. They will list their problems and goals; build coping skills; learn to relax; improve communication; and work on managing stress.\n\nSessions may be videotaped. Participants may opt out of being recorded.\n\nParticipants will have phone calls every 2 weeks during therapy. They will answer questions about how they are doing. Follow-up calls will continue for 1 year after therapy.",[26,27,28,29],"Irritability","Disruptive Mood Dysregulation Disorder","Oppositional Defiant Disorder","Attention Deficit Hyperactivity Disorder",[26,31,32,33,34,35,36,37,38,39],"Parent Management Training","Psychosocial Treatment","Exposure Therapy","Children","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy","NOT_YET_RECRUITING","2026-07-10",{"date":43,"type":44},"2026-07-13","ACTUAL",{"date":46,"type":22},"2026-07-16",{"date":48,"type":22},"2037-12-31",{"name":50,"class":51},"National Institute of Mental Health (NIMH)","NIH",1,{"id":54,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":56,"keywords":57,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":64,"locationsCount":52},"100641449",{"count":21,"type":22},[26,27,28,29],[26,31,32,33,34,35,36,37,38,39],"2026-07-01",{"date":60,"type":44},"2026-07-02",{"date":62,"type":22},"2026-07-07",{"date":48,"type":22},{"name":50,"class":51},{"id":66,"slug":67,"hasResults":12,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":19,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":52},"100645132","phase-3-a-phase-3-study-of-viloxazine-er-capsules-in-korean-children-and-adolescents-with-adhd-100645132","NCT07678827","A Phase 3 Study of Viloxazine ER Capsules in Korean Children and Adolescents With ADHD","A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Bridging Clinical Trial to Evaluate the Efficacy and Safety of Viloxazine Extended-Release (ER) Capsules (AK-D101) in Korean Children and Adolescents (6-17 Years of Age) With Attention-Deficit\u002FHyperactivity Disorder (ADHD)","AK-D101_BS","Inclusion Criteria\n\n1. Korean male or female subjects who are ≥6 and ≤17 years of age at the time of written informed consent.\n2. Subjects with a primary diagnosis of Attention-Deficit\u002FHyperactivity Disorder (ADHD) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Visit 1 (Screening).\n3. Subjects with a Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score of ≥28 at Visit 1 (Screening) and Visit 2 (Baseline).\n4. Subjects with a Clinical Global Impression-Severity (CGI-S) score of ≥4 at Visit 1 (Screening) and Visit 2 (Baseline).\n5. Subjects who meet the following body weight criteria at Visit 1 (Screening):\n\n   * 6 to 11 years of age: ≥20 kg.\n   * 12 to 17 years of age: ≥35 kg.\n6. Subjects who agree not to initiate or take any ADHD medication other than the investigational medicinal product during the study. Subjects who are taking ADHD medication at Visit 1 (Screening) but whose ADHD symptoms are not adequately controlled with their current ADHD medication, as demonstrated by meeting Inclusion Criterion 3, may participate if they meet all other inclusion\u002Fexclusion criteria and have discontinued ADHD medication at least 7 days before Visit 2 (Baseline).\n7. Subjects considered suitable for participation in the clinical trial by the investigator based on clinical laboratory tests, vital signs, and ECG assessments, meeting all of the following criteria:\n\n   * Clinical laboratory tests: Results are within the normal range or, if outside the normal range, are not considered clinically significant. However, eGFR must be ≥30 mL\u002Fmin\u002F1.73 m², AST and ALT must be \\\u003C3 × upper limit of normal (ULN), and total bilirubin must be \\\u003C2 × ULN.\n   * Vital signs: Blood pressure, pulse rate, respiratory rate, and body temperature are within the normal range or, if outside the normal range, are not considered clinically significant.\n   * 12-lead ECG: No clinically significant abnormal findings.\n8. Subjects whose legally authorized representative(s), or parent(s), and the subject, as applicable, voluntarily agree to participate in this clinical trial and provide written informed consent\u002Fassent.\n\nExclusion Criteria:\n\n1. Subjects who are currently taking viloxazine, who previously took viloxazine for the treatment of ADHD but discontinued it due to adverse reactions or lack of efficacy, or who have a history of allergic reaction, hypersensitivity\\*, or intolerance to viloxazine extended-release capsules or any of their excipients.\n\n   \\*Hypersensitivity-related excipients: lactose, sucrose, Yellow No. 5 (Sunset Yellow FCF), and Yellow No. 203 (Quinoline Yellow WS).\n2. Subjects who, at Screening according to the MINI-KID, are diagnosed with a psychiatric disorder other than ADHD as the primary diagnosis, or who have a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator, may interfere with treatment adherence to the investigational medicinal product or affect study results. However, subjects with a history of Major Depressive Disorder may be eligible if no episode has occurred within 6 months prior to the Screening visit.\n3. Subjects with a history of diagnosis of significant central nervous system (CNS) disease or neuromuscular disease, including:\n\n   * CNS diseases, such as brain tumors, inflammatory CNS diseases, epilepsy, or cerebrovascular diseases.\n   * Neuromuscular diseases with childhood onset, such as Duchenne muscular dystrophy or myasthenia gravis.\n   * History of seizures, seizure-like symptoms, such as syncope, myoclonus, or severe muscle spasms, family history of seizure disorders in first-degree relatives, parents or siblings, and\u002For febrile convulsions.\n   * Other CNS or neuromuscular diseases that, in the investigator's medical judgment, may affect participation in the clinical trial.\n4. Subjects with a history of diagnosis of medically significant systemic disease.\n5. Subjects with a history of suicidal plan\u002Fintent, suicidal ideation, or one or more suicide attempts within 6 months prior to the Screening visit.\n6. Subjects whose BMI exceeds the 95th percentile for age and sex at the Screening visit.\n7. Subjects who have taken any of the following medications within the specified period prior to the first dose of investigational medicinal product at Visit 2 (Baseline):\n\n   * Monoamine oxidase inhibitors (MAOIs) within 14 days prior to the randomization visit.\n   * CYP1A2 substrate drugs, such as theophylline, melatonin, olanzapine, or duloxetine, within 7 days prior to the randomization visit.\n8. Pregnant or breastfeeding females, or females of childbearing potential, defined as those with confirmed menarche, with a positive pregnancy test result at the Baseline visit.\n9. Females of childbearing potential, defined as those with confirmed menarche, who do not agree to use adequate contraception during the study period and for 4 weeks after the last dose of the investigational medicinal product.\n\n   (\\*) Adequate contraception includes sexual abstinence, hormonal contraceptives without known drug interactions, intrauterine hormone-releasing systems, such as a levonorgestrel intrauterine system (IUS), intrauterine devices (IUDs), and surgical sterilization, including bilateral tubal ligation, salpingectomy, and vasectomy. However, periodic abstinence methods, such as calendar, symptothermal, or post-ovulation methods, use of spermicides alone, lactational amenorrhea method, double barrier methods, simultaneous use of female and male condoms, and withdrawal are not considered acceptable contraception.\n10. Subjects with food allergies, intolerances, dietary restrictions, or special diets that, in the investigator's judgment, may make the subject unsuitable for participation in this clinical trial.\n11. Subjects who have received or used any other investigational medicinal product or medical device within 30 days prior to Visit 1 (Screening).\n12. Subjects who are otherwise considered by the investigator to be unsuitable for participation in this clinical trial.","6 Years",{"count":75,"type":22},156,"INTERVENTIONAL",[78],"PHASE3","This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter bridging clinical trial designed to evaluate the efficacy and safety of viloxazine extended-release capsules (AK-D101) compared with placebo in Korean children and adolescents aged 6 to 17 years with attention-deficit\u002Fhyperactivity disorder (ADHD). Eligible participants will be randomized in a 1:1 ratio to receive AK-D101 or placebo once daily for 8 weeks. Randomization will be stratified by study site and age group (children aged 6 to 11 years and adolescents aged 12 to 17 years). The primary efficacy endpoint is the change from baseline to Week 8, End of Treatment, in the Korean ADHD Rating Scale, 5th Edition (K-ARS-5) Total Score.",[29,81,82],"Attention-Deficit \u002F Hyperactivity Disorder","ADHD",[82,84,85,86,87,88,89,90,91,92,93],"Attention-Deficit\u002FHyperactivity Disorder","Viloxazine","Viloxazine Extended-Release","Viloxazine ER","AK-D101","Qelbree","Korean Population","Bridging Study","Pediatric ADHD","Adolescent ADHD","2026-06-30",{"date":60,"type":44},{"date":97,"type":22},"2026-07",{"date":99,"type":22},"2027-09",{"name":101,"class":102},"Alvogen Korea","INDUSTRY",{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":76,"phases":113,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":52},"100529969","enhancing-team-effectiveness-for-a-collaborative-school-based-intervention-for-adhd-100529969","NCT06180681","Enhancing Team Effectiveness for a Collaborative School-based Intervention for ADHD","Inclusion Criteria:\n\n1. Youth ages of 7-11 years (2-5th grade) who are attending a participating school\n2. Child referred by a school mental health provider (SMHP) with apparent ADHD-related problems,\n3. ≥6 symptoms (item score ≥2) of Inattention or Hyperactivity-Impulsivity on the pooled parent and teacher Child Symptom Inventory\n4. ≥3 on the Impairment Rating Scale by parent and teacher (cross-situational impairment)\n5. Caretaker and teacher consent to participate in treatment and child provides assent.\n\nExclusion Criteria:\n\n1. No presence of conditions that are incompatible with this study's treatment including: severe visual or hearing impairment, severe language delay or intellectual impairment, psychosis, pervasive developmental disorder\n2. Child is in an all-day special education classroom (children in these classrooms are frequently receiving intensive behavior modification programs such that the intervention would be expected to require modification for use in these settings)\n3. Parent\u002Fprimary caregiver or child does not read or speak English or Spanish. Note: Participants will need to be able to read\u002Fspeak English or Spanish because all measures are in English or Spanish, and the intervention will be conducted in English or Spanish. Parents will be given the option of having a research staff member assist them in completing the assessment measures.\n4. Children planning to change (start or stop) psychotropic medication Note: Children taking medication will be required to meet all entry criteria, including impairment criteria, thus indicating a need for the intervention. Children taking medication for attention or behavior are eligible as long as their medication regimens are stable.","7 Years","11 Years",{"count":112,"type":22},144,[114],"NA","The proposed project aims to integrate team-based implementation strategies with an established school-based intervention for children with ADHD, the Collaborative Life Skills Program (CLS), to enhance its implementation and optimize its effectiveness. The investigators will tailor three empirically-supported team development interventions, Team Charters, Team Communication Training (Student Handoff Protocols), and Team Performance Monitoring, and integrate them into a team-enhanced CLS implementation protocol (CLS-T). Team Charters are a written document developed collaboratively by the team at the outset of their work together outlining expectations, goals, roles and responsibilities, and relevant policies and procedures for team collaborative operations. Research shows that Team Charters strengthen affective emergent states, such as trust and cohesion among team members, as well as cognitive emergent states, such as shared mental models. They also strengthen team processes, such as goal specification, communication, and coordination to optimize team effectiveness. Handoff protocols are widely used interventions for ensuring continuity in patient care and minimizing errors in medical settings. They have also been found to improve affective (e.g., trust, cohesion) and cognitive (e.g., shared mental models, situation awareness) emergent states among team members, enhancing team communication and coordination. Finally, Team Performance Monitoring provides feedback to teams that can motivate performance, provide opportunities for adaptation in the event of challenges, and prompt communication among team members. The investigators will conduct a Hybrid Type III cluster randomized trial in 24 schools in two large urban school districts, to evaluate whether CLS-T implementation results in improved implementation outcomes and child outcomes in comparison to standard CLS implementation.",[117,118,119,120],"Team-effectiveness Research","School-based Interventions","Attention Deficit\u002F Hyperactivity Disorder","Implementation Science","RECRUITING","2026-06-29",{"date":94,"type":44},{"date":125,"type":44},"2024-01-01",{"date":127,"type":22},"2028-01",{"name":129,"class":130},"University of California, San Diego","OTHER",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":141,"conditions":142,"keywords":147,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":52},"100410940","developing-brain-impulsivity-and-compulsivity-100410940","NCT04631042","Developing Brain, Impulsivity and Compulsivity","An Observational Study of the Developing Brain, Impulsivity and Compulsivity","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study.\n2. Must be between 6 and 80 years of age.\n3. Ability of participant to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures or lack of capacity to provide informed consent. Indications of a lack of cognitive capacity could include a known full-scale IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. Very premature birth (i.e., birth before 32 weeks of gestational age).\n3. Any known brain abnormalities (e.g., tumor, periventricular leukomalacia, microcephaly) or history of medical conditions known to affect cerebral anatomy (e.g., epilepsy, history of stroke, head injury with a loss of consciousness of one hour or more).\n4. Psychotic disorders (including schizophrenia, psychosis not otherwise specified).\n5. Dementia, or other conditions that, in the opinion of the investigators, would impede compliance or possibly hinder completion of the study.\n6. Pregnant women.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments.\n\nAdditional exclusion criteria for optional MRI procedure:\n\n1\\. Individuals who are not able to receive an MRI (e.g., metal bioimplants, claustrophobia, inability to lie flat on their backs, pregnant women, and any other contraindications for MRI scanning according to the NMR Center MRI safety guidelines).","80 Years",{"count":140,"type":22},1100,"Background:\n\nImpulsivity is acting 'without thinking.' Compulsivity is being overly inflexible. People vary in how impulsive or compulsive they are. Extreme versions of these behaviors play a role in mental disorders. Researchers want to study changes in the brain to learn more about these behaviors. Differences in genes may also play a role.\n\nObjective:\n\nTo learn about genetic \\& brain features that explain why levels of impulsivity and compulsivity vary across people.\n\nEligibility:\n\nPeople ages 6 - 80\n\nDesign:\n\nParticipants will be screened with a medical history and medical record review.\n\nParticipants will talk about their mental and behavioral development. They may discuss topics like drug use and sexual activity. They will complete surveys about their compulsivity and impulsivity. Parents of child participants may also complete these surveys.\n\nParticipants may take memory, attention, and thinking tests. They may give blood or saliva samples for gene studies and they may give blood to make induced pluripotent stem cells. Participants may have their face and irises photographs taken.\n\nParticipants may have a magnetic resonance imaging scan. It will take pictures of their brain. The scanner is shaped like a cylinder. Participants will lie on a table that slides in and out of the scanner. A coil will be placed over their head. They will lie still, watch a movie, and play a game.\n\nParticipants may ask family members to join the study. Researchers are particularly interested in recruiting twin pairs to the study.\n\nParticipants under age 25 may repeat these tests every 1-2 years until they turn 25 or until the study ends. For those over age 25, participation will last less than 1 month.",[143,144,145,29,146],"Typical Development","Obsessive Compulsive Disorder","Conduct Disorder","Autism Spectrum Disorder",[148,149,150,151,152,153,154],"Neurodevelopmental disorder","Twin","Natural History","Heritability","Glutamate","developmental trajectory","Brain Connectivity","2026-06-24",{"date":157,"type":44},"2026-06-25",{"date":159,"type":44},"2022-09-30",{"date":161,"type":22},"2031-12-31",{"name":50,"class":51},{"id":164,"slug":165,"hasResults":12,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":76,"phases":173,"briefSummary":174,"conditions":175,"keywords":176,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":52},"100644271","effectiveness-of-neuroplasticity-targeted-supplements-on-neuroinflammatory-markers-adhd-symptom-severity-and-clinical-scores-in-children-100644271","NCT07665658","Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children","Effectiveness of Neuroplasticity-Targeted Supplements on Neuroinflammatory Markers, ADHD Symptom Severity, and Clinical Scores in Children: A Randomized Controlled Trial","Inclusion Criteria:\n\n* DSM-5 confirmed ADHD diagnosis\n* Age 6-12 years\n* Medication-free or on stable stimulant medication (≥1 month)\n\nExclusion Criteria:\n\n* Antibiotic use in last 4 weeks\n* Gastrointestinal disorders\n* Neurological comorbidities (e.g., epilepsy)\n* Severe food allergies","12 Years",{"count":172,"type":22},68,[114],"This randomized controlled trial will evaluate the effectiveness of neuroplasticity-targeted supplements on neuroinflammatory markers and ADHD symptoms in children aged 6 to 12 years diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Participants will be randomly assigned to one of four groups: gut-targeted supplements (prebiotics and probiotics), brain-targeted supplements (omega-3 fatty acids and vitamin B1), combined supplementation, or placebo. The intervention period will last 12 weeks. Primary outcomes include changes in ADHD symptom severity and clinical scores using validated rating scales. Secondary outcomes include changes in biomarkers of neuroinflammation and neuroplasticity, including IL-6, TNF-alpha, BDNF, short-chain fatty acids, and Claudin-5.",[29],[29,177,178,179],"Randomized Controlled Trial","Neuroinflammation","Neuroplasticity","2026-06-22",{"date":155,"type":44},{"date":183,"type":44},"2026-03-01",{"date":185,"type":22},"2026-12-25",{"name":187,"class":130},"Khyber Medical University Peshawar",{"id":189,"slug":190,"hasResults":12,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":76,"phases":199,"briefSummary":200,"conditions":201,"keywords":202,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":52},"100608556","effects-of-transcranial-photobiomodulation-in-adhd-100608556","NCT07203092","Effects of Transcranial Photobiomodulation in ADHD","Effects of Transcranial Photobiomodulation on Cognition and Brain Metabolism in Adults With ADHD","Inclusion Criteria:\n\n* English-speaking\n* Adults of any sex\n* Age range: 18-44 years\n* Any ethnic\u002Fracial background\n* Medical history of ADHD\n* Participants may either be on a stable ADHD medication regimen (with no changes within two weeks prior to the study) or not taking medication.\n\nExclusion Criteria:\n\n* Currently pregnancy\n* Any sham or active photobiomodulation treatment within the past five weeks.","18 Years","44 Years",{"count":198,"type":22},140,[114],"The investigators have previously shown that non-invasive methods of brain stimulation such as the administration of transcranial infrared light to the prefrontal cortex (PFC) can result in improvements to cognition and emotion as well as brain oxygenation. This method is called transcranial photobiomodulation (tPBM).\n\nThe investigators hypothesize that tPBM can improve cognition and brain oxygenation in adults with attention deficit hyperactivity disorder (ADHD). The investigators will investigate the effects of repeated tPBM sessions on cognitive functioning in adults with ADHD. Specifically, the investigators hypothesize that participants that receive tPBM will show improvements in response control, sustained attention, and working memory, as well as improvements in prefrontal hemodynamics and a reduction in ADHD symptoms.",[29],[82,203,204,205,206],"transcranial photobiomodulation","cognition","prefrontal cortex","brain metabolism","2026-06-17",{"date":180,"type":44},{"date":210,"type":44},"2025-09-01",{"date":212,"type":22},"2027-12",{"name":214,"class":130},"Francisco Gonzalez-Lima, PhD",{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":221,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":222,"targetDuration":4,"studyType":76,"phases":224,"briefSummary":225,"conditions":226,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":52},"100500932","neurocognitive-effects-of-non-invasive-near-infrared-light-stimulation-100500932","NCT05802680","Neurocognitive Effects of Non-Invasive Near-Infrared Light Stimulation","Inclusion Criteria:\n\n* 18 years of age or older\n\nExclusion Criteria:\n\n* None",true,{"count":223,"type":22},500,[114],"Inattentiveness and impulsivity in healthy adults and individuals with attention deficit hyperactivity disorder (ADHD) diminish these individuals' quality of life. Cortical hypometabolism has been hypothesized to contribute to inattentiveness in ADHD. Transcranial photobiomodulation (tPBM) is a safe and non-invasive modality for activation of the prefrontal cortex. tPBM in healthy adults has been shown to augment brain oxygenation, cognition, and mood. The cognition-enhancing effect of tPBM on sustained attention in adults with ADHD remains unstudied. The investigators will evaluate whether tPBM administration to adults with and without ADHD can improve their attention. Each participant will be screened for eighteen criteria based on the Diagnostic and Statistical Manual (DSM-IV, text revised), using the validated instrument Adult ADHD Self-Report Scale (ASRS-v1.1). Blinded participants will be randomized into (I) Active-tPBM or (II) Sham-tPBM groups. After undergoing an 8-minute administration of Sham or 1064 nm tPBM to the lateral and medial right prefrontal cortex, each participant will complete a 14-minute, computer-based Conner's continuous performance task-3 (CPT-3). The investigators will examine whether adults with and without ADHD who receive Active-tPBM improve in measures of inattention, impulsivity, sustained attention, or vigilance compared to the Sham-tPBM group. Cognitive assessments of attention like the CPT-3 may evaluate the efficacy of tPBM to increase cortical metabolism in healthy adults and individuals with conditions like ADHD. The investigators anticipate their investigation will be a starting point for more sophisticated studies that focus on the implications of tPBM on cognition.",[29,227,228,229,230],"Attention Difficulties","Attention Deficit","Cognitive Deficit","Wellness",{"date":180,"type":44},{"date":233,"type":44},"2022-02-09",{"date":235,"type":22},"2027-02-01",{"name":214,"class":130},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":76,"phases":246,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100593056","phase-1-a-study-to-test-how-bi-3031185-is-tolerated-by-people-with-borderline-personality-disorder-or-attention-deficithyperactivity-disorder-100593056","NCT07001475","A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit\u002FHyperactivity Disorder","A Phase Ib, Multicentre, Randomised, Double Blind, Placebo Controlled, 2 Sequence Crossover Trial to Evaluate the Effects of BI 3031185 on Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics in Patients With Borderline Personality Disorder or Attention-deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* Male, female, and non-binary participants, 18 to 45 years of age, both inclusively, at the time of consent\n* Meet current diagnostic and statistical manual of mental disorders, fifth edition (DSM-5) criteria as primary diagnosis as assessed by the mini international neuropsychiatric interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit\u002Fhyperactivity disorder (ADHD). With full implementation of version 5.0 of this clinical trial protocol (CTP), only participants with a primary diagnosis of ADHD as assessed by the MINI will be included in the trial.\n* Willingness to abstain from alcohol for 24 h, and all other drugs of abuse including cannabis for 72 h prior to Visits 2 and 3 (Day -1). Willingness to abstain from alcohol and cannabis for 72 h after investigational medicinal product (IMP) administration, as well as from all other recreational drugs for the duration of the trial\n* Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2 and 3 (Day -1) and 24 h following IMP administration Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, autism spectrum disorder, or antisocial personality disorder as confirmed by the MINI\n* Any other psychiatric disorder that is not currently stable in symptoms and treatment\n* Any substance use disorder within 3 months prior to randomisation (excluding mild alcohol, cannabis, tobacco, and caffeine use disorders); or moderate to severe substance use disorder within the 6 months prior to randomisation (excluding tobacco and caffeine)\n* Positive drug screen. Participants with positive cannabis drug tests can be included if they do not meet criteria for moderate or severe cannabis use disorder and the investigator determines that use will not be an impediment to trial participation or accurate data collection\n* Concomitant use of psychotropic medication except for the ones below. All other psychotropic medications must be washed out at least 30 days or 5 Half-life time (t1\u002F2) (whichever is longer) before the start of Visit 2 (Day -1)\n\n  1. A single SSRI (selective serotonin re-uptake inhibitor) or SNRI (selective serotonin and norepinephrine re-uptake inhibitor) antidepressant that has been stable in dose and frequency for \\>3 months prior to randomisation\n  2. A single second-generation antipsychotic at a low dose that has been stable in dose and frequency for \\>3 months prior to randomisation (low dose = 1 thorazine dose equivalent or less, which translates to ≤2 mg\u002Fday for risperidone, 5 mg\u002Fday for olanzapine, 75 mg\u002Fday for quetiapine, 60 mg\u002Fday for ziprasidone, and 7.5 mg\u002Fday for aripiprazole)\n  3. A single sleep medication given as a nightly scheduled medication (not pro re nata) stable in agent and dose for \\>3 months prior to screening. Allowed sleep medications include: non-benzodiazepine Z sleep medications, antihistamines, melatonin, trazodone, and doxepin\n  4. Participants taking psychostimulant medication prescribed as per label for ADHD must stop medication 72 h prior to Visits 2 and 3 (Day -1) and may resume 24 h after receiving the medication dose on the test day (i.e. 5 days total off of prescribed psychostimulant for Visit 2 and 5 days off of prescribed psychostimulant for Visit 3)\n* Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix\n* A positive result for any active hepatitis\n* Previous randomisation in this trial Further exclusion criteria apply.","45 Years",{"count":172,"type":22},[247],"PHASE1","This study is open to adults with certain mental health conditions. The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with certain mental health conditions.\n\nParticipants are put into 2 groups of equal size randomly, which means by chance. Group 1 takes a single dose of BI 3031185 and Group 2 takes placebo. After a 2-week break, Group 1 takes placebo and Group 2 takes a single dose of BI 3031185. Participants take BI 3031185 and placebo as tablets.\n\nParticipants are in the study for about 3 months. They visit the study site 6 times and have 3 phone or video call visits. For 2 of the visits, participants stay overnight at the study site for 2 nights. During all the visits, doctors check participants' health and take note of any unwanted effects.",[250,29],"Borderline Personality Disorder","2026-06-12",{"date":253,"type":44},"2026-06-15",{"date":255,"type":44},"2025-08-12",{"date":257,"type":22},"2026-11-27",{"name":259,"class":102},"Boehringer Ingelheim",7,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":76,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":52},"100261929","motor-attention-training-for-attention-deficit-hyperactivity-disorder-adhd-100261929","NCT02688959","Motor Attention Training for Attention Deficit Hyperactivity Disorder (ADHD)","A Feasibility\u002FPilot Trial of a Motor Attention Training Intervention for College Students With ADHD","Inclusion Criteria:\n\n* University of Wisconsin-Madison enrolled undergraduate\n* Documented ADHD diagnosis\n\nExclusion Criteria:\n\n* Unable or unwilling to participate in the interventions","23 Years",{"count":270,"type":22},145,[114],"The investigators will perform a feasibility\u002Fpilot trial of two non-pharmacological interventions for ADHD in college students.",[29],[275,276,277,82],"motor attention training","exercise","tai chi","2026-05-28",{"date":280,"type":44},"2026-06-01",{"date":282,"type":4},"2016-02",{"date":284,"type":22},"2028-12",{"name":286,"class":130},"University of Wisconsin, Madison",{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":76,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":303,"leadSponsor":305,"locationsCount":4},"100522265","cbt-for-adult-inmates-with-adhd-100522265","NCT06080373","CBT for Adult Inmates With ADHD","Formulation-Based Cognitive-Behavioral Therapy Compared to an Active Control and a Waitlist in Adult Inmates With ADHD: A Randomized Controlled Trial","Inclusion Criteria:\n\n* To have signed written informed consent to participate in the study\n* To be between 18 and 65 years of age\n* To meet the DSM-5 diagnostic criteria for ADHD (American Psychiatric Association, 2013)\n* To have been convicted of at least one crime under Spanish or German criminal law\n* To have been incarcerated for at least six months and three or fewer years since the completion of the conviction at the time of eligibility assessment.\n\nExclusion Criteria:\n\n* To have a severe personality disorder, psychotic disorder, or pervasive developmental disorder as their primary diagnosis, as the intervention would not meet their clinical needs\n* To have an IQ of 80 or less, as measured by a standardized IQ test (Raven et al., 1993), due to the complexity of the cognitive components in the CBT program\n* To have participated in a previous psychological intervention for ADHD;\n* To not be fluent in Spanish or German, depending on the study site.",{"count":295,"type":22},111,[114],"Background Recent literature suggests that ADHD is a risk factor for the development of antisocial behavior that is more severe and persistent than in community and other psychiatric populations. The combination of stimulant medication and psychotherapy (particularly cognitive-behavioral therapy, CBT) is considered an evidence-based intervention for adults with ADHD. In contrast, few studies have evaluated the efficacy of medication in adult prisoners with ADHD, and the literature on the efficacy of psychotherapy is virtually nonexistent. Therefore, this article presents the protocol of a trial that will assess the efficacy of a formulation-based CBT program for inmates with ADHD.\n\nMethods The study has a multicenter randomized controlled trial design. After screening and recruitment, participants will be randomly assigned to the CBT intervention, a general offender treatment program, or a waitlist. Pre- and post-treatment self-report and clinician-report assessments, as well as 6- and 12-month follow-up assessments will be conducted. These will include both clinical (e.g., ADHD symptoms, depression and anxiety symptoms, self-esteem, alcohol\u002Fdrug abuse, treatment adherence, quality of life) and criminological (e.g., recidivism and risk of recidivism) measures. Linear mixed models will be used to assess differences between groups.\n\nDiscussion This study may be the first to evaluate the efficacy of a psychotherapy intervention in adult inmates with ADHD. It is expected that addressing the specific needs of ADHD would not only result in the previously reported clinical improvements (e.g., reduction in ADHD and comorbidity symptoms), but also reduce the risk and rate of recidivism compared to the general intervention or no intervention. However, the design may be limited by the difficulties inherent in the prison setting and in following up the sample after release.",[29],"2026-04-29",{"date":301,"type":44},"2026-05-06",{"date":99,"type":22},{"date":304,"type":22},"2029-09",{"name":306,"class":130},"Universidad Europea de Valencia",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":221,"sex":17,"minAge":109,"maxAge":170,"enrollmentInfo":314,"targetDuration":4,"studyType":76,"phases":315,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":318,"lastUpdatePostDateStruct":319,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":52},"100628784","the-effect-of-playful-physiotherapy-intervention-100628784","NCT07466147","The Effect of Playful Physiotherapy Intervention","The Effect of Playful Physiotherapy Intervention on Emotional Self-regulation in Children Aged 7-12 Years Old With Neurodevelopmental and Behavioral Special Needs in a Rehabilitation Setting.","Inclusion Criteria:\n\n* Age 5-12 years;\n* Clinical diagnosis: ADHD, ASD, behavioral regulation difficulties, and\u002For social adaptation difficulties in group settings;\n* Participation in physiotherapy at ProVida Clinic or assessment by the clinic's rehabilitation team regarding suitability for participation;\n* Ability to participate in movement- and play-based activities in a group format;\n* Proficiency in Estonian;\n* No prior participation in a similar group.\n\nExclusion Criteria:\n\n* Acute or chronic medical condition that prevents active participation;\n* Severe cognitive or sensory impairment that prevents understanding of activities or safe participation;\n* Situations in which the child's participation may disrupt group functioning or compromise safety.",{"count":7,"type":22},[114],"The goal of this quasi-experimental study is to evaluate the changes in emotional, behavioral, and psychosocial functioning of children aged 7-12 following a playful physiotherapy intervention. The study focused on the potential effects of a play- and body-based intervention on children's daily functioning, based on parent-reported assessments\n\nThe main question\\[s\\] it aims to answer \\[is\u002Fare\\]:\n\nParticipants will be evaluated based on the Strengths and Difficulties Questionnaire and KIDSCREEN-27 before and after the playful physiotherapy intervention programme.",[29,146],"2026-04-28",{"date":320,"type":44},"2026-05-05",{"date":322,"type":22},"2026-05",{"date":324,"type":22},"2027-02",{"name":326,"class":130},"University of Tartu",{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":29,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":334,"enrollmentInfo":335,"targetDuration":4,"studyType":76,"phases":337,"briefSummary":338,"conditions":339,"keywords":342,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":359},"100533930","attention-deficit-hyperactivity-disorder-100533930","NCT06232226","Addictions and Attention Deficit Disorder With or Without Hyperactivity","ADA","Inclusion Criteria :\n\n* Patients aged over 18 years\n* For whom a diagnosis of ADHD has been confirmed less than 12 weeks ago\n* For whom the diagnosis of one or more addictive disorder(s) (substance use disorder or behavioral addiction) has been confirmed\n* Meeting the indication for treatment with MPH according to European recommendations (Kooij et al., 2019)\n* For patients who can actually benefit from MPH: who have not yet started taking MPH\n* Social security affiliates\n\nExclusion Criteria :\n\n* Presenting disorders of higher cognitive functions (at the discretion of the referring clinician or the investigator making the inclusion), making data collection impossible\n* Presenting difficulties in reading or writing the French language making data collection impossible\n* Unable to commit to being available for the 2 visits planned as part of the cohort\n* Under guardianship or legal protection\n* Patients who have used psychoactive substances within 12 hours prior to their visit","99 Years",{"count":336,"type":22},80,[114],"The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.",[29,340,341],"Behavior Hyperactive","Behavior Disorders",[343,344,345,346,347,348,349],"Attention Deficit Disorder with Hyperactivity","Addictive disorders","Neuropsychology","Methylphenidate","Atomoxetine","Functional impairment","Symptoms","2026-04-14",{"date":352,"type":44},"2026-04-17",{"date":354,"type":44},"2024-04-11",{"date":356,"type":22},"2026-12-31",{"name":358,"class":130},"Nantes University Hospital",3,{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":364,"acronym":365,"eligibilityCriteria":366,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":367,"enrollmentInfo":368,"targetDuration":4,"studyType":76,"phases":370,"briefSummary":371,"conditions":372,"keywords":375,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":52},"100626718","characterization-of-social-cognition-profiles-in-children-and-adolescents-with-neurodevelopmental-disorders-a-clinical-study-using-a-multidimensional-battery-100626718","NCT07439276","Characterization of Social Cognition Profiles in Children and Adolescents With Neurodevelopmental Disorders: a Clinical Study Using a Multidimensional Battery","COGSO","Inclusion Criteria:\n\n* Children and adolescents aged 8 to 16 years\n* Proficiency in French (native language)\n* Information and consent obtained from those holding parental authority, and agreement from the child or adolescent\n* No recently modified (\\\u003C6 weeks) psychotropic medication from the following categories: antidepressants, anxiolytics, antipsychotics, psychostimulants, mood stabilizers.\n* IQ above 70 (WISC-V)\n* Criteria for Neurodevelopmental Disorders: Diagnosis of Autism Spectrum Disorder or Attention Deficit Hyperactivity Disorder (according to DSM-5)\n* Multiple complex developmental disorder : Symptoms characteristic of a neurodevelopmental disorder without meeting all the criteria for a specific disorder and presence of multiple complex developmental disorder criteria with at least 5 elements from the specified categories.\n\nExclusion Criteria:\n\n\\- Having an active neurological disorder (e.g., active epilepsy)","16 Years",{"count":369,"type":22},100,[114],"In France, more than one in ten school-aged children suffers from a mental health disorder, and half of these disorders appear before the age of 14. Yet, only half of affected children receive appropriate support. At the cognitive level, it is now widely accepted by the scientific community that strong socio-cognitive skills protect against the emergence of certain disorders. Social cognition skills, crucial for development and social integration, are often underestimated in clinical neuropsychology, particularly due to the lack of validated assessment tools for children.\n\nThe challenges related to the clinical assessment of social cognition in children and adolescents are therefore significant, especially since specific deficits are likely to be associated with numerous developmental pathologies and psychiatric disorders (neurodevelopmental disorders, mood disorders, anxiety disorders, psychotic disorders). However, these disorders are insufficiently assessed. A more precise characterization would allow for the identification of therapeutic targets specific to each neurodevelopmental disorder.\n\nTherefore, this research aims to address this lack of tools by using a multidimensional assessment battery of social cognition in children and adolescents aged 8 to 16, evaluating four fundamental domains of social cognition: emotion processing, social perception, theory of mind, and attributional style. This multidimensional assessment battery of social cognition is developed by the Child and Adolescent Psychiatry Department of Necker-Enfants Malades Hospital.",[373,146,29,374],"Neurodevelopmental Disorders","Atypical Neurodevelopmental Disorder",[376,146,29,377,378,379],"Neurodevelopmental disorders","Atypical neurodevelopmental disorder","Social cognition","Children and teenagers","2026-04-13",{"date":382,"type":44},"2026-04-16",{"date":384,"type":44},"2026-04-08",{"date":386,"type":22},"2029-04",{"name":388,"class":130},"Assistance Publique - Hôpitaux de Paris",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":395,"eligibilityCriteria":396,"healthyVolunteers":221,"sex":17,"minAge":397,"maxAge":398,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100383878","pharmacokinetics-pharmacodynamics-and-safety-profile-of-understudied-drugs-administered-to-children-per-standard-of-care-pops-100383878","NCT04278404","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)","Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs","POPS or POP02","Inclusion Criteria:\n\n1. Participant is \\\u003C 21 years of age\n2. Parent\u002F Legal Guardian\u002F Adult Participant can understand the consent process and is willing to provide informed consent\u002FHIPAA:\n3. (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment\n\nExclusion Criteria:\n\n1. Participant has a known pregnancy\n\n   Below exclusion criteria apply only to:\n\n   Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)\n2. Has had intermittent dialysis within previous 24 hours\n3. Has had a kidney transplant within previous 30 days\n4. Has had a liver transplant within previous 1 year\n5. Has had a stem cell transplant within previous 1 year\n6. Has had therapeutic hypothermia within previous 24 hours\n7. Has had plasmapheresis within the previous 24 hours\n8. Has a Ventricular Assist Device\n9. Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study","0 Years","20 Years",{"count":400,"type":22},5000,"The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.",[403,404,405,406,407,408,409,410,411,412,413,414,415,416,417,418,419,420,421,422,29,423,424,425,426],"Coronavirus Infection (COVID-19)","Pulmonary Arterial Hypertension","Urinary Tract Infections in Children","Hypertension","Pain","Hyperphosphatemia","Primary Hyperaldosteronism","Edema","Hypokalemia","Heart Failure","Hemophilia","Menorrhagia","Insomnia","Pneumonia","Skin Infection","Arrythmia","Asthma in Children","Bronchopulmonary Dysplasia","Adrenal Insufficiency","Fibrinolysis; Hemorrhage","Multisystem Inflammatory Syndrome in Children (MIS-C)","Kawasaki Disease","Coagulation Disorder","Down Syndrome","2026-03-31",{"date":429,"type":44},"2026-04-06",{"date":431,"type":44},"2020-03-05",{"date":433,"type":22},"2027-07",{"name":435,"class":130},"Duke University",51,{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":170,"enrollmentInfo":444,"targetDuration":4,"studyType":76,"phases":446,"briefSummary":447,"conditions":448,"keywords":452,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":52},"100544791","matching-assessment-and-treatment-for-children-with-disruptive-behaviour-and-their-parents-100544791","NCT06373484","Matching Assessment and Treatment for Children With Disruptive Behaviour and Their Parents","MATCH-DB","Inclusion Criteria:\n\n* Child is borderline\u002Fclinically at risk on the Child Behaviour Checklist (CBCL) or Teacher Report Form (TRF) (T-score greater than or equal to 60 on Externalizing Problems composite scale or a T-score greater than or equal to 65 on the Oppositional Defiant Disorder and\u002For Conduct Disorder scales)\n* Child has clinically severe impairment in the interpersonal relations (greater than 3), functioning in schoolwork (greater than 3), or total domains (greater than 15) on the Columbia Impairment scale.\n* Parent is able and willing to participate in a group treatment\n\nExclusion Criteria:\n\n* Child has an ongoing query or diagnosis of Pervasive Developmental Disorder or Autism or Asperger's Disorder\n* Evidence of cognitive delays or an intellectual disability (based on the Kauffman Brief Intelligence Test-2 (KBIT-2), verbal and\u002For IQ composite standard score below 80 or collateral information)\n* Child behaviour or emotional functioning that make group participation not possible\n* Child preference for individual treatment.\n* Parent behaviour or emotional functioning that make group participation not possible\n* Parent preference for individual treatment.",{"count":445,"type":22},200,[114],"This study will develop and test whether personalized profiles of children with Disruptive Behaviour Disorder (DBD) and their parents based on important psychological, emotional, and neuropsychological indicators predict their response to child cognitive behavioral treatment and Behavioral Parent Training.",[449,450,451,29,145,28],"Disruptive Behavior Disorder","Emotional Disorder","Behavioural Disorder",[453,454,29,145,28,455,456],"Emotional and Behavioural Disorders","Disruptive Behaviour Disorder","Parenting Skills","Behavioural Parenting Training","2026-03-16",{"date":459,"type":44},"2026-03-17",{"date":461,"type":44},"2022-10-01",{"date":99,"type":22},{"name":464,"class":130},"Centre for Addiction and Mental Health",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":73,"maxAge":170,"enrollmentInfo":472,"targetDuration":4,"studyType":76,"phases":474,"briefSummary":475,"conditions":476,"keywords":477,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":482,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":52},"100626038","improving-self-regulation-in-individuals-with-adhd-through-adapted-karate-training-100626038","NCT07430436","Improving Self-regulation in Individuals With ADHD Through Adapted Karate Training","Improving Self-regulation, Social Participation, and Functional Performance in Individuals With ADHD Through Adapted Karate Training: A Randomized Controlled Crossover Trial","Inclusion Criteria:\n\n* Diagnosed by a developmental neurologist with ADHD\n* Age 6-12 years\n* Fluent in Hebrew\n\nExclusion Criteria:\n\n* Comorbidity with another psychiatric or neurological diagnosis, or a developmental syndrome\n* Chronic pain\n* enrolled in a special education system\n* substance abuse (i.e., reporting more than 10 cups of alcohol a week)\n* currently participating in other non-pharmaceutical therapies (e.g., cognitive therapies) started during the past 6 months.",{"count":473,"type":22},55,[114],"The goal of this clinical trial is to examine the effectiveness of Adaptive Karate Training (AKT) in improving self-regulation and daily function in children with ADHD, exploring the underlying mechanisms.\n\nThe main questions it aims to answer are:\n\n1. Is the AKT more effective than no karate training in enhancing functional performance, self-regulation and school QoL?\n2. Are poorer executive functions, emotional regulation, and sensory processing associated with higher gains?\n\nResearchers will compare two sequences: (1) A group receiving AKT followed by a no-intervention period; (2) A group receiving no intervention, followed by the AKT intervention, to see if differences are observed between intervention and no-intervention periods, both between groups and within participants over time.\n\nParticipants will engage in AKT sessions twice a week, each session lasting 60 minutes, over a period of two months.",[29],[29,478,479,480,481],"Self Regulation","Karate","Occupational Therapy","Participation","2026-02-23",{"date":484,"type":44},"2026-02-24",{"date":486,"type":22},"2026-02-26",{"date":488,"type":22},"2027-12-30",{"name":490,"class":130},"Tel Aviv University",{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":4,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":498,"enrollmentInfo":499,"targetDuration":4,"studyType":76,"phases":501,"briefSummary":503,"conditions":504,"keywords":505,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":516},"100605993","phase-4-r6133---vr-study-phase-4-100605993","NCT07169760","R61\u002F33 - VR Study Phase 4","Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD","Inclusion Criteria:\n\n* Participants must meet DSM-5 criteria for ADHD\n* Between the ages of 18 and 25\n* Given high rates of comorbidities in college students with ADHD, participants who meet criteria for ODD, anxiety or depressive disorders on the diagnostic interview are not excluded\n* Participants must have an item mean score of \\>2.0 (often or very often) on the homework task specific version of the Adult Concentration Index (ACI), ensuring the presence of a problem in the mechanism being targeted in this study\n* The participant has to endorse a total of at least 5 symptoms in the ADHD inattention domain as currently present and impairing and at least 6 symptoms in the ADHD inattention domain as present and impairing during childhood\n* To rule out exclusionary conditions and\u002For to assess for the presence of comorbid conditions, psychological functioning will be assessed using the DSM-5 version of the Structured Clinical Interview for DSM Disorders (SCID-5-RV)\n\nExclusion Criteria:\n\n* Whether primary or not, the comorbid presence of several other conditions will be exclusionary.This includes autism spectrum disorders, bipolar disorder, obsessive-compulsive disorder, active substance abuse, and other psychiatric conditions whose treatment precludes participation in the study.\n* Students who do not meet criteria for ADHD are not eligible\n* Students who are not in the specified age range are also not eligible to participate\n* Students with a history of seizures are not eligible to participate given the use of VR","25 Years",{"count":500,"type":22},252,[502],"PHASE4","The goal of this larger parallel group randomized trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.",[29],[82,506],"Virtual reality","2026-01-26",{"date":509,"type":44},"2026-01-28",{"date":511,"type":44},"2025-09-09",{"date":513,"type":22},"2030-12",{"name":515,"class":130},"Rutgers, The State University of New Jersey",2,{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":170,"maxAge":19,"enrollmentInfo":523,"targetDuration":4,"studyType":76,"phases":525,"briefSummary":526,"conditions":527,"keywords":528,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":530,"startDateStruct":532,"completionDateStruct":534,"leadSponsor":536,"locationsCount":52},"100541127","adhd-presma-response-inhibition-therapy-100541127","NCT06325813","ADHD PreSMA Response Inhibition Therapy","Inclusion Criteria:\n\n1. ADHD diagnosis\n2. Ages 12-17 years\n3. Stimulant use is allowed but must be discontinued 24 hours prior to and during days of TMS visit\n\nExclusion Criteria:\n\n1. Medical conditions contraindicated or associated with altered TMS risk profile, including history of intracranial pathology, epilepsy or seizure disorders, traumatic brain injury, brain tumor, stroke, intellectual disability, cerebral palsy, neurodegenerative conditions, hearing impairment, metallic objects in the head or any other serious medical condition\n2. Presence of any implanted medical devices (e.g., ports, shunts, stimulators, cochlear implants)\n3. For biological females who are post-menarche, current pregnancy based on urine pregnancy test.\n4. Baseline problem of hearing impairment or chronic tinnitus\n5. Any clinically significant finding on brain MRI\n6. History of DSM-5 conduct disorder, major depressive disorder, bipolar disorder, obsessive compulsive disorder, anxiety disorder, psychotic disorder\n7. Non-stimulant medication(s) for ADHD (e.g., alpha2 adrenergic agonist, atomoxetine, tricyclics)\n8. Neuroleptic\u002Fantipsychotic medication(s)\n9. Inability to undergo MRI\n10. Active suicidality, history of suicidality, or high risk for suicide as assessed by a study physician\n11. Substance abuse or dependence within the past year, based on 1) separate screening process of asking parent\u002Fguardian and participant, and 2) positive urine drug screen. Exception will be made for positive urine drug screen due to prescribed ADHD medication",{"count":524,"type":22},40,[114],"ADHD children have abnormal inhibitory control, meaning they have trouble stopping themselves from doing something they should not do. This ability to control involves an area in the brain called the pre-supplementary motor area (pre-SMA). Scientists have previously shown that the pre-SMA is abnormal in ADHD patients. In this study, we will use Transcranial Magnetic Stimulation (TMS) to stimulate the pre-SMA and determine the effects on measures that are related to inhibitory control.",[29],[82,529],"Transcranial Magnetic Stimulation",{"date":531,"type":44},"2026-01-27",{"date":533,"type":44},"2024-09-03",{"date":535,"type":22},"2027-12-31",{"name":537,"class":130},"Children's Hospital Medical Center, Cincinnati",{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":367,"enrollmentInfo":544,"targetDuration":4,"studyType":76,"phases":546,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":556,"lastUpdatePostDateStruct":557,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":52},"100486004","phase-1-development-of-virtual-reality-based-interventions-to-strengthen-cognitive-skillsets-related-to-attention-deficit-hyperactivity-disorder-adhd-a-pilot-phase-i-and-randomized-controlled-phase-ii-trial-100486004","NCT05608434","Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate, an individual must meet all of the following criteria:\n\n1. Children must provide informed assent and parents must provide informed consent to participate in the study.\n2. Any sex assigned at birth, or race\u002Fethnicity.\n3. Aged between 8 and 16 years of age, including all months leading up to age 17.\n4. Meets diagnosis for ADHD, predominately inattentive or combined presentations, or a specified presentation of having prominent symptoms of inattention that are impairing in two or more settings (but not numerous enough to meet a diagnosis of inattentive or combined presentation).\n5. Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study.\n6. For the Pilot only: If treated for ADHD with psychostimulants, willing to withdraw medication three days prior to baseline assessments and to stay off medication until completion of the post-intervention assessment. Not receiving any other psychotropic medication for at least 30 days prior to baseline assessment.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Cognitively not capable of performing study procedures. Indications of a lack of cognitive capacity could include a known IQ under 70, or a history from the screening interview that implies global intellectual disabilities (e.g., placement in a school for children with intellectual disability etc.)\n2. History of severe migraines, vertigo, epilepsy (with the exception of febrile seizures), or serious balance disorders.\n3. Impairments in uncorrected visual acuity that would interfere with engagement with the VR training.\n4. Known to be pregnant.\n5. Psychotic disorders (including schizophrenia, psychosis not otherwise specified), current substance dependence. Other psychiatric disorders elicited on the interview are not considered exclusionary provided that ADHD is considered to be one of the dominant sources of impairment for the child.\n6. Considered a suicide risk as determined during the clinical interview at baseline.\n7. Any other medical or psychiatric condition that in the opinion of the PI may confound study data\u002Fassessments (e.g., limitations in mobility that would render the VR headset unusable).\n8. Recent (within three months) treatment with other cognitive training interventions (e.g., Cogmed) for ADHD.\n9. The VR equipment produces excessive discomfort to the child in the opinion of the PI (e.g., including participants with small interpupillary distances (IPD) that are only able to see blurry images on the VR headset, or children showing signs of undue neck and upper body strain or fatigue while trying the headset).\n10. For the main trial only: Certain psychotropic medications classes that are likely to interfere with the completion of the intervention are exclusionary: antipsychotics, mood stabilizers (lithium, valproate, lamotrigine, gabapentin). Medications for ADHD will not be considered as exclusionary. This includes psychostimulants, atomoxetine, alpha 2 adrenergic agonists. Antidepressant and anxiolytic medication will also not be exclusionary if they are deemed not to not interfere with study procedures\n11. For the main trial only: Prior use of Floreo s products including but not limited to their ADHD cognitive training application.",{"count":545,"type":22},219,[247,547],"PHASE2","Background:\n\nChildren with attention deficit hyperactivity disorder (ADHD) often have cognitive problems. It may be hard for them to control their behaviors, concentrate for long periods, or make decisions. This can affect their education, friendships, and daily life. Virtual reality-based games may help improve cognitive skills in children with ADHD. It may also help change how the brain functions.\n\nObjective:\n\nTo see if virtual reality-based games help improve thinking skills and brain function in children with ADHD.\n\nEligibility:\n\nChildren aged 8 to 16 years with ADHD.\n\nDesign:\n\nWe will first do a pilot study, meaning that everyone will receive the games. If this is successful, we will then conduct a randomized controlled trial, meaning that some participants will be randomly assigned to the full version of the games and some will be randomly assigned to a limited version. Participants will be screened. Their physical and mental health, medical and family history, and intellectual and emotional development will be evaluated. They will have tests of their mood, memory, attention, thinking, and behavior. Blood or saliva may be collected. Participants may have an MRI scan of the brain.\n\nParticipants will receive a set of virtual reality games. The set includes 4 different games all played using a virtual reality headset. The participant will play the games for 20 minutes 5 days a week for 4 weeks.\n\nThe parent or caregiver will start each game using an iPad. Each of the games is designed to help the participant practice specific cognitive skills. These include inhibition control, processing speed, temporal information processing, and working memory.\n\nParticipants will have interviews each week. They will answer questions about motion sickness, eye strain, headache, and any other side effects, as well as number of game sessions played.\n\nBlood or saliva tests and the MRI may be repeated after the last game session. For the pilot, participants will have a final interview at the study end. For the full trial, a 1-month follow-up visit will be done by telehealth.",[29],[551,552,553,554,555],"Smart Games","Neurodevelopmental","Virtual Reality","fMRI","Cognitive Training","2025-11-21",{"date":558,"type":44},"2025-11-24",{"date":560,"type":44},"2024-03-15",{"date":562,"type":22},"2028-06-01",{"name":50,"class":51},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":221,"sex":17,"minAge":195,"maxAge":570,"enrollmentInfo":571,"targetDuration":4,"studyType":76,"phases":573,"briefSummary":574,"conditions":575,"keywords":581,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":52},"100385276","transcranial-direct-current-stimulation-tdcs-neuromodulation-of-executive-function-across-neuropsychiatric-populations-100385276","NCT04296604","Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations","Inclusion Criteria\n\n1. Male and female outpatients 18-65 years of age\n2. A diagnosis of traumatic brain injury, major depressive disorder, bipolar disorder, schizophrenia, attention deficit hyperactivity disorder, borderline personality disorder and substance use disorders meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.\n\nExclusion Criteria\n\n1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, shunts, pacemakers, pregnancy.\n2. Active substance dependence (except for tobacco and cannabis).\n3. Pregnant or nursing females.\n4. Inability to participate in testing procedures.\n5. Additional exclusion criteria for healthy controls:\n\n   1. Diagnosis of psychiatric of neurological disorder\n   2. Ongoing treatment with any psychotropic medications.","65 Years",{"count":572,"type":22},600,[114],"In the current study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in improving executive function across neuropsychiatric populations known to have deficits in this cognitive domain.",[576,577,578,579,29,250,580],"Traumatic Brain Injury","Major Depressive Disorder","Bipolar Disorder","Schizophrenia","Substance Use Disorders",[582,583],"Transcranial Direct Current Stimulation","Executive Function","2025-09-04",{"date":586,"type":44},"2025-09-10",{"date":588,"type":44},"2014-09",{"date":590,"type":22},"2026-04",{"name":592,"class":130},"Massachusetts General Hospital",{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":599,"eligibilityCriteria":600,"healthyVolunteers":221,"sex":17,"minAge":601,"maxAge":602,"enrollmentInfo":603,"targetDuration":4,"studyType":76,"phases":605,"briefSummary":606,"conditions":607,"keywords":611,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":620,"locationsCount":52},"100410661","project-peak-early-intervention-for-adhd-100410661","NCT04627415","Project PEAK: Early Intervention for ADHD","Early Intervention for Young Children At-Risk for ADHD: Evaluating Efficacy and Delivery Format for Behavioral Parent Education","PEAK","Inclusion Criteria:\n\n* 3- to 5.11-year old children with clinically significant symptoms of ADHD.\n* Children had to have met DSM-5 criteria for one of the three presentations of ADHD based on clinical interview and parent and teacher behavior ratings, including parent and teacher report of elevated levels of impairment at home and school (i.e., score greater than 90th percentile on one or more Conners Early Childhood Rating Scale subscales relevant to ADHD).\n\nExclusion Criteria:\n\n* A diagnoses of autism spectrum disorder (ASD), pervasive developmental disorder, intellectual disability, neurological damage, or significant motor or physical impairments.\n* Children needed to be enrolled in a pre-school or day care setting at least 2 days a week unless otherwise unable to enroll (e.g. behavioral problems, lack of services for unrelated disability) in order to establish the presence of symptoms across two settings.","3 Years","5 Years",{"count":604,"type":22},180,[114],"Parent education is an effective and relatively cost efficient approach for reducing child behavior problems. Research, however, suggests that the effectiveness of parent education is mitigated by parent attendance and parent implementation of intervention strategies. That is, low attendance at parent education sessions is associated with limited intervention effects. Therefore, it is critical to identify strategies to enhance parent engagement. A previous pilot randomized controlled trial of a parent education program (Behavioral Parent Education; BPE, specifically Promoting Engagement for ADHD pre-Kindergartners \\[PEAK\\]), found that both face-to-face (F2F) and online BPE resulted in high levels of parent engagement and child behavior improvements. However, results need to be replicated in a full scale efficacy trial with a larger, diverse sample to provide more reliable estimates of relative effect sizes for parent and child outcomes and to evaluate the extent to which parent and child behavior changes are maintained after BPE has ended. In the current randomized controlled trial, the investigators intend to apply What Works Clearinghouse group design standards to examine the efficacy of two forms of delivery of BPE (F2F and online) relative to a wait-list control condition in a sample of 180, 3- to 5-year old children with clinically significant symptoms of ADHD. The objective is to: (a) extend findings from the pilot investigation to a large, diverse sample; (b) examine maintenance of effects; (c) identify moderators and mediators of treatment outcome, especially the degree to which these may differ for F2F vs. online treatment delivery; and (d) assess cost and cost-effectiveness of the two PEAK delivery formats.",[29,608,609,610],"Parent-Child Relations","Child Behavior","Parenting",[82,612,613,614],"Behavioral Parent Training","Early Intervention","Preschool","2025-09-02",{"date":511,"type":44},{"date":618,"type":44},"2020-09-01",{"date":356,"type":22},{"name":621,"class":130},"Lehigh University",{"id":623,"slug":624,"hasResults":12,"nctId":625,"briefTitle":626,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":170,"enrollmentInfo":630,"targetDuration":4,"studyType":76,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":641,"completionDateStruct":643,"leadSponsor":645,"locationsCount":52},"100525592","virtual-reality-in-rehabilitation-of-executive-functions-in-children-with-attention-deficit-hyperactivity-disorder-100525592","NCT06123741","Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.","Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)","VREALFUN-ADHD","Inclusion Criteria:\n\n* Diagnosis of ADHD (ICD-10 F90.0) and\n* Methylphenidate medication and\n* Age 8-12 years and\n* Finnish as a native language\n\nExclusion Criteria:\n\n* Sensitivity to flashing light,\n* Epilepsy (ICD-10 G40),\n* Mental retardation (ICD-10 F70-F79),\n* Pervasive developmental disorders (ICD-10 F84),\n* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),\n* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),\n* Traumatic brain injury ((ICD-10 S06),\n* Brain tumour, and\n* Multiple pregnancy",{"count":631,"type":22},88,[114],"Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.\n\nThe major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.\n\nResearchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.",[29],[29,636,583,553,637],"Attention","Child","2025-08-29",{"date":640,"type":44},"2025-09-05",{"date":642,"type":44},"2024-01-10",{"date":644,"type":22},"2025-12-31",{"name":646,"class":130},"Merja Nikula",{"id":648,"slug":649,"hasResults":12,"nctId":650,"briefTitle":651,"officialTitle":652,"acronym":653,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":655,"targetDuration":4,"studyType":76,"phases":657,"briefSummary":658,"conditions":659,"keywords":661,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":666,"lastUpdatePostDateStruct":667,"startDateStruct":669,"completionDateStruct":671,"leadSponsor":672,"locationsCount":674},"100511152","evaluation-of-a-home-based-parenting-support-program-parenting-young-children-100511152","NCT05935722","Evaluation of a Home-based Parenting Support Program: Parenting Young Children","Evaluation of a Home-based Parenting Support Program - Parenting Young Children - for Parents With Intellectual and Developmental Disabilities When There is a Risk for Neglect","PYC","Inclusion Criteria:\n\n* Parents with IDDs, including ID and other cognitive disabilities (e.g., ADHD and ASD).\n* Parents must have children aged 0-9 years living at home and be assessed by the social services to be eligible for tailored parenting support.\n\nExclusion Criteria:\n\n* Ongoing substance abuse, and\u002For mental illness of such nature and degree that it may affect parent management training.\n* Ongoing child abuse.",{"count":656,"type":22},60,[114],"Background: Parents with intellectual and developmental disabilities (IDDs) have a tendency to provide insufficient caregiving and often need parenting support to prevent neglect and child removal. However, parents with IDDs are not provided with appropriate support, and there is a lack of evidence-based programmes tailored to these parents' needs. Parenting Young Children (PYC) is a home-based parenting programme developed for parents with IDDs. PYC has shown promising clinical results in interview-based studies, but there is no evidence of its effectiveness. The purpose of the proposed study is to evaluate the PYC programme for improving parenting in parents with IDDs where there is risk of child neglect. The study will include a quantitative evaluation, a process evaluation, and a qualitative evaluation of the children's and parents' perspectives on participating in PYC.\n\nMethods: The quantitative evaluation will have a multi-centre, non-randomised, comparative study design. Eligible for participation are parents with IDDs who have children aged 0-9 years living at home and who are assessed as needing tailored parenting support. Thirty parents receiving PYC and thirty parents receiving treatment as usual (TAU) will be recruited from Swedish municipal social services. Outcome variables will be examined before and after the intervention, with a follow-up 6 months after completing the intervention. The primary outcome will be goal-attainment in parenting skills, and secondary outcomes will be parental self-efficacy and children's wellbeing. Interview methods will be used to explore the perspectives of parents and children in the PYC group.\n\nDiscussion: This study is motivated by the need for evidence-based support for parents with IDDs, and it focuses on upholding the centrality of child-caregiver relationships and family preservation, as well as children's rights and the rights of people with disabilities. Social services have expressed ethical concerns with employing a randomized design for this vulnerable group, and this study will therefore evaluate PYC in a non-randomized comparative study.",[660,29,146],"Intellectual Disability",[662,663,664,665],"Intellectual and developmental disabilities","parents","parenting skills","support programme","2025-08-11",{"date":668,"type":44},"2025-08-14",{"date":670,"type":44},"2022-09-08",{"date":94,"type":22},{"name":673,"class":130},"Örebro University, Sweden",5,{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":17,"minAge":682,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":76,"phases":685,"briefSummary":686,"conditions":687,"keywords":690,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":697,"completionDateStruct":699,"leadSponsor":700,"locationsCount":674},"100484132","paiact-programme-for-parents-of-children-with-special-healthcare-needs---phase-i-100484132","NCT05584059","Pai.ACT Programme for Parents of Children With Special Healthcare Needs - Phase I","Pai.ACT: A Deep-Learning Mental Health Advisory System Using Acceptance and Commitment Therapy for Parents of Children With Special Healthcare Needs (Phase I)","Inclusion Criteria:\n\n* Cantonese-speaking Hong Kong residents\n* living together with the child who is at preschool\u002Fschool-age (3-9 years old)\n* adopt the responsibility of taking care of the child,\n* has daily access to their iPhone and Android smartphones.\n\nIn addition, potential eligible parents who respond \"yes\" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https:\u002F\u002Fwww.childhealthdata.org\u002Fdocs\u002Fcshcn\u002Ftechnical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental\u002Femotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.\n\nExclusion Criteria:\n\n* Parents with severe mental illness or developmental disabilities which impaired their ability to comprehend the content of the programme will be excluded.","21 Years",{"count":684,"type":22},150,[114],"This study aims to determine the feasibility, acceptability and potential efficacy of an individual, video-conferencing based Focused Acceptance and Commitment Therapy (FACT) on the mental well-being of parents of children with Special Health Care Needs(SHCN). The study also aims to explore the experience of parents after participating in the individual-based FACT sessions offered by the trained FACT interventionists.",[373,29,146,688,689],"Development Delay","Chronic Disease",[691,692,693,694],"Focused Acceptance and Commitment Therapy","Special health care needs","Mobile App","Machine Learning","2025-08-08",{"date":666,"type":44},{"date":698,"type":44},"2022-12-01",{"date":644,"type":22},{"name":701,"class":130},"Chinese University of Hong Kong"]