[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"behavioral-symptoms\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:behavioral-symptoms":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,63,98,127,161,187,222,246,296,330,369],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":45,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100551600","natural-history-of-depression-bipolar-disorder-and-suicide-risk-100551600",false,"NCT06462196","Natural History of Depression, Bipolar Disorder and Suicide Risk","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Signed consent for Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers\n* Age 18 years or older\n* Able to provide informed consent\n* Able to read and write English\n\nEXCLUSION CRITERIA:\n\n* Unstable medical conditions in the opinion of the investigator that would preclude participation in outpatient or inpatient treatment.\n* Pregnancy\n* Participation in the Protocol 01-M-0254: The Evaluation of Patients with Mood and Anxiety Disorders and Healthy Volunteers, as a healthy volunteer.\n* Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to consent and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to enrolling in the study. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician.","ALL","18 Years","120 Years",{"count":19,"type":20},500,"ESTIMATED","OBSERVATIONAL","Mood disorders, such as depression and bipolar disorder, are difficult to treat. One reason is that there are no objective ways to measure how these disorders affect the body and respond to different treatments. In this study, researchers want to perform tests on people undergoing clinical care for mood disorders. The purpose is to understand the experience of receiving treatment for depression, bipolar disorder, and suicide risk. We also hope that this study will help us to predict which medications will improve thoughts of suicide.\n\nPeople 18 years or older who are receiving treatment for depression, bipolar disorder, or suicide risk may take part in this study. Participants must have also been enrolled in protocol 01-M-0254.\n\nThis study will be conducted at the NIH Clinical Center in Bethesda, MD. The study typically lasts up to 12 weeks, but may last longer if a participant s treatment continues past that time.\n\nParticipants will have weekly interviews and questionnaires while they are being treated for their mood disorder. Other tests are optional and include psychological testing, blood draws, sleep tests, and imaging scans. These will be done at the start and the end of research participation.",[24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Behavioral Symptoms","Suicide","Self-Injurious Behavior","Sensory System Agents","Analgesics","Peripheral Nervous System Agents","Physiological Effects of Drugs","Anesthetics, Dissociative","Anesthetics, General","Anesthetics","Central Nervous System Depressants","Excitatory Amino Acid Antagonists","Excitatory Amino Acid Agents","Neurotransmitter Agents","Molecular Mechanisms of Pharmacological Action","Ketamine","Depression, Unipolar","Depressive Symptoms","Treatment Resistant Depression","Major Depressive Disorder","Depression, Bipolar",[46,25,43,47,48,49,42],"Neurobiology","Bipolar Disorder","Biomarkers","Suicide Risk","RECRUITING","2026-06-26",{"date":53,"type":54},"2026-06-29","ACTUAL",{"date":56,"type":54},"2024-09-09",{"date":58,"type":20},"2030-06-01",{"name":60,"class":61},"National Institute of Mental Health (NIMH)","NIH",1,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":84,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":62},"100555424","phase-2-investigation-of-the-antidepressant-effects-of-2r6r-hnk-an-enhancer-of-synaptic-glutamate-release-in-treatment-resistant-depression-100555424","NCT06511908","Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","An Investigation of the Antidepressant Effects of (2R,6R)-HNK, an Enhancer of Synaptic Glutamate Release, in Treatment-Resistant Depression","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and willingness to sign a written informed consent document. To verify this, participants must score \\>= 80% on the consent quiz.\n2. Stated willingness to comply with all study procedures and availability for the duration of the study.\n3. 18 to 70 years of age.\n4. All participants must have undergone a screening assessment under protocol 01-M-0254.\n5. Participants must fulfill DSM-IV or DSM-5 criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Participants must be experiencing a current major depressive episode lasting at least two weeks.\n6. Participants must have an initial score of \\>= 20 on the MADRS and a YMRS score of \\\u003C12 within one week of study entry and upon entry into Phase II.\n7. Ability to take intravenous medication and be willing to adhere to the (2R,6R)-HNK regimen.\n8. Participants must have a current or past history of lack of response to at least one adequate antidepressant trial (may be from the same chemical class), with at least one in the current major depressive episode, operationally defined using the modified Antidepressant Treatment History Form (ATHF); non-response to an adequate trial of ECT or TMS would count as an adequate antidepressant trial.\n9. For individuals of reproductive potential: use of highly effective contraception starting at the time of enrollment and agreement to use such a method during study participation and for an additional four weeks after the end of Study Phase II.\n10. For males of reproductive potential: use of condoms or other methods from the time of enrollment to ensure effective contraception with partner, and for an additional 90 days after the end of Phase II.\n11. Agreement to adhere to Lifestyle Considerations throughout study duration.\n12. Medically healthy, or with stable, treated, chronic medical conditions (provided any medications are not excluded)\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Current use of disallowed concomitant medications or transcranial magnetic stimulation (TMS) two weeks prior to the start of Phase II.\n2. Treatment with a reversible monoamine oxidase inhibitor (MAOI) four weeks prior to the start of Phase II.\n3. Treatment with fluoxetine, aripiprazole, or brexpiprazole five weeks prior to the start of Phase II.\n4. Treatment with clozapine or electroconvulsive therapy (ECT) four weeks prior to the start of Phase II.\n5. Ongoing treatment with moderate or strong CYP3A4\u002F5 inhibitors or inducers\n6. Lifetime history of deep brain stimulation.\n7. Previous antidepressant non-response to ketamine or esketamine (full course).\n8. No structured psychotherapy will be permitted during the total duration of the study. Participants unable or unwilling to stop psychotherapy will be unable to participate in the study.\n9. Pregnancy or lactation.\n10. Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV or DSM-5.\n11. Participants with a history of DSM-IV substance or alcohol abuse or dependence, or DSM-5 substance use disorder (except for caffeine, nicotine, or cannabis), or moderate to severe alcohol use disorder, within the preceding three months. In addition, participants who are currently using drugs (except for caffeine, nicotine, or cannabis) must not have used illicit substances or known drugs of abuse in the two weeks prior to screen and must have a negative drug urine test (except for prescribed benzodiazepines or stimulants) prior to starting Phase II. Cannabis use is exclusionary if the use is daily, or if participants are unable to abstain during the study, or if function of daily life is impaired by use as determined by a clinician. Due to the interactions between cannabis and SSRIs, frequent cannabis use during previous antidepressant treatment will result in that treatment being considered a failed trial for eligibility purposes.\n12. Participants with a DSM-IV or DSM-5 Axis II diagnosis of borderline or antisocial personality disorder.\n13. Participants with a history of head injury that resulted in loss of consciousness exceeding five minutes (for the imaging component of the study).\n14. No serious, unstable medical illnesses including but not limited to the following body systems and organs or those that in the judgment of the Principal Investigator pose a risk to the participant's ability to safely participate in the study: Hepatic diseases (e.g. active viral hepatitis infection or cirrhosis of the liver, any liver disease with Child-Pugh score \\>=5), cardiovascular disease (including ischemic heart disease, coronary artery disease, congestive heart failure, poorly controlled hypertension due to risk of further blood pressure elevation and increase in demand on cardiac function from study drug), renal\u002Furologic (e.g chronic kidney disease or acute kidney injury, history of bladder dysfunction due to theoretical risk of ketamine-induced cystitis, moderate to severe renal impairment of any etiology), endocrinologic (including uncontrolled diabetes due to association with progressive abnormality of the microvasculature and nervous system), or neurologic disease (e.g. elevated intraocular pressure or history of or presence of diseases that are associated with elevated intracranial pressure).\n15. Participants with unstable clinical hyperthyroidism or hypothyroidism.\n16. Participants with one or more seizures without a clear and resolved etiology.\n17. Clinically significant abnormal laboratory tests specifically defined by:\n\n    * Alkaline phosphatase (Alk Phos) \\> 150 U\u002FL\n    * Alanine aminotransferase (ALT) \\> 55 U\u002FL\n    * Aspartate aminotransferase (AST) \\> 34 U\u002FL\n    * Total bilirubin (TB) \\> 1.2 mg\u002FdL\n    * Direct bilirubin (DB) \\> 0.5 mg\u002FdL\n    * 25-hydroxyvitamin D \\\u003C 20 ng\u002FmL\n    * Folate \\\u003C 2ng\u002FmL\n    * Vitamin B12 \\\u003C 200 pg\u002FmL\n18. Moderate to severe renal impairment with body surface area corrected eGFR \\\u003C60mL\u002Fmin.\n19. Participants who, in the Principal Investigator's judgment, pose a current serious suicidal or homicidal risk.\n20. Positive HIV test.\n21. Contraindications to MRS (metal in body, claustrophobia, etc. for imaging)\n22. Participants with COVID-19 or suspected COVID-19\n23. Inability to read and understand English. Non- English speakers will not be eligible as most of the required monitoring and rating instruments are not validated in languages other than English.","70 Years",{"count":72,"type":20},50,"INTERVENTIONAL",[75],"PHASE2","Background:\n\nMajor depressive disorder (MDD) is a serious mental illness that can put people at risk of self-harm and death. Many drugs are used to treat MDD, but it can take a long time for them to be effective. Researchers want to know if a faster-acting drug, (2R,6R)-hydroxynorketamine (HNK), can better treat the symptoms of MDD.\n\nObjective:\n\nTo test a study drug (HNK) in people with MDD.\n\nEligibility:\n\nPeople aged 18 to 70 years with MDD. They must have had a screening assessment under protocol 01-M-0254.\n\nDesign:\n\nParticipants will be tapered off their current MDD drugs over 2 to 5 weeks. They will stay off of the drugs for up to 2 weeks prior to starting the study medication and procedures. They will have a physical exam with blood tests. They will have tests of their heart function, mood, and thinking. They will answer questions about their symptoms. They may choose to have imaging scans and scans of their brain activity.\n\nHNK is given through a tube attached to a needle inserted into a vein. Participants will receive infusions on this schedule:\n\nThey will receive 4 infusions over 2 weeks. They will stay in the clinical center overnight after each infusion or for the duration of the study.\n\nThey will receive no drugs for 2 to 3 weeks.\n\nThey will have 4 more infusions over 2 weeks, with overnight stays after each or for the duration of the study.\n\nOne set of 4 infusions will be the HNK. The other set of 4 infusions will be a placebo. A placebo looks just like the real drug but contains no medicine. Participants will not know when they are getting the HNK or placebo.\n\n...",[25,78,39,38,37,36,30,79,80,81,82,83,24],"Depressive Disorder, Treatment-Resistant","Depressive Disorder, Major","Depressive Disorder","Depression","Mental Disorders","Mood Disorders",[43,39,48,85,86,87,46,88,89],"Neuropharmacology","Magnetic Resonance Imaging","Magnetoencephalography","Glutamate","Hydroxynorketamine","2026-06-13",{"date":92,"type":54},"2026-06-16",{"date":94,"type":54},"2024-11-06",{"date":96,"type":20},"2027-07-01",{"name":60,"class":61},{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":15,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":73,"phases":110,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":62},"100551440","health-equity-and-rural-education-here-clinical-trial-100551440","NCT06460116","Health Equity and Rural Education (HERE!) Clinical Trial","Health Equity and Rural Education (HERE!) Clinical Trial: A Healthcare-Community Partnership Leveraging School-Based Community Health Workers to Improve Student Attendance","HERE","Phase I Stakeholder Interviews (nonintervention):\n\nInclusion Criteria:\n\n* A member of the program's Community Advisory Board, including community health workers;\n* Caregiver of a child ages 12-18 from the Southeast Kansas region; or\n* Student at least 12 years in age.\n\nPhase II Feasibility Pilot- SB-CHW Intervention and Enhanced Usual Care Conditions\n\nInclusion Criteria:\n\n* Children ages 12-18 and their parents\u002Fguardians from the Southeast Kansas region\n* Student with or at risk for chronic poor attendance (missing 10% or more of the days that school has been in session at any point in the school year)\n\nExclusion Criteria:\n\n* Parents\u002Fguardians or youth with profound intellectual\u002Fcognitive disability will be excluded.",true,"12 Years",{"count":109,"type":20},126,[111],"NA","The goal of this community-engaged research is two-fold. The first goal is to gather stakeholder feedback to inform a school-based community health worker intervention with youth with poor school attendance and an enhanced usual care condition. The second goal is to evaluate the feasibility of implementing the school-based community health worker intervention and enhanced usual care approach within rural schools.\n\nThe main question it aims to answer is whether it is feasibile to recruit children with poor school attendance and their families to the intervention, to complete the trauma-informed intervention, and to complete the associated study measures of meeting social determinants of health\u002Fmental health needs, school-based health center utilization, and behavioral helath symptoms. At least 38 rural students in grades 6-12 with poor school attendance and their parents\u002Fguardians will meet with the school-based community health worker for support around social determinants of health needs that may be barriers to attendance. Researchers will also assess the feasibility of recruiting at least 10 rural students and their parents\u002Fguardians to complete the study measures in an enhanced usual care condition in which the school-based health center without a school-based community health worker is reminded of the availability of an online social services directory.",[24,114,115,116],"Community Health Workers","Social Determinants of Health","Educational Problems","2026-04-17",{"date":119,"type":54},"2026-04-20",{"date":121,"type":20},"2026-05-15",{"date":123,"type":20},"2026-12-31",{"name":125,"class":126},"University of Kansas Medical Center","OTHER",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":106,"sex":15,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":138,"conditions":139,"keywords":147,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100634125","the-voided-urinary-perineal-and-faecal-microbiota-among-children-and-adolescents---the-ppuf-study-100634125","NCT07535619","The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents - the PpUF-study.","The Voided Urinary, Perineal, and Faecal Microbiota Among Children and Adolescents With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children and Adolescents - the PpUF-study.","Inclusion Criteria:\n\n* Overactive bladder as per International Children's Continence Society criteria (cases only).\n* At least two wet days per week (cases only).\n* No prior pharmacological treatment of OAB and DUI (cases only).\n* No lower urinary tract symptoms (healthy participants only).\n* Negative urine dipstick test\n\nExclusion Criteria:\n\n* No known urogenital abnormality affecting the lower urinary tract function.\n* No known gastrointestinal or neurological diseases.\n* No use of systemic drugs within five half-lives of the drug.\n* No use of systemic antibiotics within three months before inclusion\n* No current urinary tract infection.\n* No urinary tract infection within the last three months prior to inclusion.\n* No current constipation.\n* Abnormal uroflowmetry (healthy participants only).","5 Years","17 Years",{"count":137,"type":20},110,"The aim of this study is to investigate whether the voided urinary, perineal\u002Fpreputial, and the fecal microbiota are different between children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the study aims to investigate if the microbiota is different according to the severity of DUI and if the microbiota is changed throughout treatment of DUI. A follow-up study will as well be performed on healthy children to investigate how the microbiota evolves with increasing age and pubertal stage. Children with OAB and DUI will be recruited from involved pediatric departments, and specimen in the form of urine, perineal\u002Fpreputial swabs, and feces will be collected according to the protocol.",[140,141,142,143,144,145,146,24],"Urinary Incontinence","Daytime Wetting","Urination Disorders","Urologic Diseases","Lower Urinary Tract Symptoms","Urological Manifestations","Elimination Disorders",[148,149,150,151],"Voided Urinary Microbiota","Perineal Microbiota","Fecal Microbiota","Illumina MiSeq Sequencing","2026-04-15",{"date":117,"type":54},{"date":155,"type":54},"2022-12-14",{"date":157,"type":20},"2028-06",{"name":159,"class":126},"Aalborg University Hospital",4,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":106,"sex":15,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":73,"phases":172,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":181,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":160},"100515295","brain-activity-among-children-with-overactive-bladder-and-daytime-urinary-incontinence-and-healthy-children-100515295","NCT05989646","Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children","Brain Activity Among Children With Overactive Bladder and Daytime Urinary Incontinence and Healthy Children, and Modulation of Brain Activity by Transcutaneous Electrical Nerve Stimulation - a Functional Magnetic Resonance Imaging Study","Inclusion Criteria:\n\n* Overactive Bladder as per International Children's Continence Society criteria (cases only).\n* At least 2 incontinence episodes per week (cases only).\n* No urinary tract symptoms (healthy participants only).\n* More than 3 daily urinations.\n* Normal clinical examination.\n\nExclusion Criteria:\n\n* Known urogenital abnormality affecting the lower urinary tract function.\n* Prior surgery in the urinary tract (except circumcision).\n* Known neurological diseases or prior cerebral surgery.\n* Known neuropsychiatric disorders or suspicion of those by screening.\n* Treatment with pharmacological agents affecting the brain function.\n* Prior treatment with Enuresis Alarm or Transcutaneous Electrical Nerve Stimulation.\n* Prior or current treatment with mirabegron or oxybutynin.\n* Current urinary tract infection.\n* Current constipation according to Rome IV-criteria or faecal incontinence.\n* Claustrophobia.\n* Metallic items in the body contraindicating MRI-scans.\n* Abnormal uroflowmetry (healthy participants only).","6 Years","14 Years",{"count":171,"type":20},65,[111],"The aim of this study is to investigate whether the activity in brain areas controlling the bladder is different among children suffering from Overactive Bladder (OAB) and Daytime Urinary Incontinence (DUI) compared to age- and gender-matched healthy children without bladder symptoms. Moreover, the aim is to investigate if sacral transcutaneous electric nerve stimulation (TENS) has a central mechanism of action. Children with OAB and DUI will be recruited from involved pediatric departments, and functional magnetic resonance imaging (fMRI) will be performed before and after 10 weeks of sacral TENS. In healthy children without bladder symptoms, only the baseline fMRI will be performed.",[140,141,142,175,143,144,145,24,82,146],"Urination Involuntary",[177,178,179,180],"Transcutaneous Electrical Nerve Stimulation","TENS","Functional Magnetic Resonance Imaging","fMRI",{"date":119,"type":54},{"date":183,"type":54},"2021-05-05",{"date":185,"type":20},"2027-12",{"name":159,"class":126},{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":15,"minAge":107,"maxAge":4,"enrollmentInfo":194,"targetDuration":4,"studyType":73,"phases":196,"briefSummary":197,"conditions":198,"keywords":201,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100631882","integrating-the-youth-nominated-support-team-yst-with-cbt-for-black-youth-with-acute-suicide-risk-aim-2b-100631882","NCT07506460","Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk: Aim 2b","Integrating the Youth Nominated Support Team (YST) With CBT for Black Youth With Acute Suicide Risk","Youth Inclusion Criteria:\n\n* Patients that are able to provide at least one verifiable contact for emergency or tracking purposes\n* Willing to receive care at MiSide\n* Present to an acute emergency care setting with suicide risk (per protocol)\n* Self-identify as Black\n* Willing and able to complete enrollment procedures\n* Willing and able to provide signed and dated informed assent\n\nYouth Exclusion Criteria:\n\n* Unable to be consented in English\n* Do not have a parent\u002Flegal guardian available to provide consent\n* Are not able to provide informed assent or to participate in the assessment due to significant agitation, psychosis, cognitive impairment, learning disability, or medical trauma\n* Actively engaged in specialty mental health treatment\n* Participated in the Aim 2a open trial\n\nParent\u002FGuardian Inclusion Criteria:\n\n* Adults 18 years and older\n* The parent or legal guardian of a youth participating in this Aim\n* Understand written and spoken English\n* Willing and able to complete enrollment procedures\n* Willing and able to provide signed and dated informed consent\n* Need to have access to technology, either cell or an email address\n\nParent\u002FGuardian Exclusion Criteria:\n\n\\- Do not understand written and spoken English\n\nSupport Person Inclusion Criteria:\n\n* Adults 18 years and older\n* Understand written and spoken English\n* Approved to serve as a support person by the parent\u002Flegal guardian\n\nSupport Person Exclusion Criteria:\n\n* Do not understand written and spoken English\n* Not approved to serve as a support person by the parent\u002Fguardian",{"count":195,"type":20},90,[111],"This is a second pilot study being completed based on lessons learned from the Aim 2a feasibility pilot study (NCT06941311). Following modifications, the investigators are testing the acceptability, feasibility, and preliminary effectiveness of the combination of two psychosocial interventions, Cognitive Behavioral Therapy for Suicide Prevention (CBT-SP) and the computer-assisted version of the Youth-Nominated Support Team (eYST).\n\nIn this phase of the study, CBT-SP + eYST will be tested in an open trial (number of youth = 15). Investigators will recruit Black adolescents (ages 12-17) that come to an urban acute care setting for suicidal thoughts and\u002For self-injurious behaviors to receive the intervention in an outpatient community mental health agency. Participants will receive 12-14 sessions of CBT-SP in addition to YST. Participants will nominate up to 5 caring adults in their lives to serve as support persons. These support persons will attend an education\u002Forientation session to learn more about their role and how to support the youth. Support persons will have weekly contact with the youth and weekly follow up contacts from the youth's clinician\u002FYST intervention specialist.\n\nYouth will be assessed at baseline, 6 weeks, and 14 weeks. Parents will be assessed at baseline and 14 weeks. Support persons will be assessed at baseline and 14 weeks.\n\nFidelity assessments will be completed by clinicians after each session, after the YST psycho-ed session, and weekly to document contact with the support team.",[199,25,26,24,200],"Suicide Prevention","Behavior",[202,203,204,205,206,207,208,209,210,211],"Black youth","Acute suicide risk","Youth Nominated Support Team","Cognitive Behavioral therapy for Suicide Prevention","Community Mental Health","Suicide prevention","Behavior Therapy","Psychotherapy","Behavioral Disciplines and Activities","Cognitive Behavioral Therapy","2026-03-26",{"date":214,"type":54},"2026-04-01",{"date":216,"type":54},"2026-03-23",{"date":218,"type":20},"2026-08",{"name":220,"class":126},"University of Michigan",2,{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":15,"minAge":230,"maxAge":135,"enrollmentInfo":231,"targetDuration":4,"studyType":73,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":237,"lastUpdatePostDateStruct":238,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":221},"100524208","regulating-together-in-tuberous-sclerosis-complex-100524208","NCT06105736","Regulating Together in Tuberous Sclerosis Complex","Regulating Together in Tuberous Sclerosis Complex: A Pilot Feasibility Study in Children and Adolescents With TSC-Associated Neuropsychiatric Disorder (TAND)","RT","Inclusion Criteria:\n\n* Children ages 8-17 years inclusive with a documented clinical and\u002For genetic diagnosis of TSC and exhibiting symptoms of behavioral dysregulation (identified on the TAND Checklist having temper tantrums, aggressive outbursts, self-injury, and\u002For impulsivity) are eligible for inclusion.\n\nAdditional inclusion\u002Feligibility criteria include:\n\n* Participants and their caregivers have access to a computer, phone, or tablet with video capability and stable internet connection. If lack of a device or internet service is the sole barrier to eligibility\u002Fparticipation, interested individuals will be connected to a TSC Clinic social worker to link them to existing government and charity programs specifically addressing this disparity in underserved communities and households in need (e.g., the Affordable Connectivity Program).\n* Participants must also be willing to participate in treatment sessions and have minimal levels of functional verbal communication (child and their caregiver must be fluent in English\n* Child must have a minimum IQ\\>65 on the WASI-II at the screening\u002Fbaseline visit).\n\nExclusion Criteria:\n\n* Participants be on a stable medication regimen at least 4 weeks prior to enrollment\n* Do not have a plan to start a new psychosocial intervention (e.g., individual psychotherapy, family psychotherapy, group psychotherapy or social skills training) or behavior medication within 30 days prior to enrollment or at any point during the study. ----Participants with significant disruptive, aggressive, self-injurious or sexually inappropriate behaviors deemed potentially dangerous or overly disruptive to the group dynamic\u002Fsession, having significant co-occurring neuropsychiatric illness warranting other treatment approaches as determined by study clinician (e.g., substance use disorders, psychotic disorders, schizophrenia), or having significant sensory impairment that would limit participation in intervention curriculum\u002Fmaterials (e.g., blindness or uncorrected hearing loss) also will be excluded.","8 Years",{"count":232,"type":20},105,[111],"The purpose of this study is to use a program called Regulating Together (RT), a remote, non-pharmacologic intervention to treat symptoms of emotion dysregulation in children and adolescents with Tuberous Sclerosis Complex (TSC) and TSC-Associated Neuropsychiatric Disorder (TAND).",[236,24],"TSC","2025-12-18",{"date":239,"type":54},"2025-12-24",{"date":241,"type":54},"2023-12-20",{"date":243,"type":20},"2026-12-20",{"name":245,"class":126},"Children's Hospital Medical Center, Cincinnati",{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":252,"eligibilityCriteria":253,"healthyVolunteers":106,"sex":15,"minAge":254,"maxAge":255,"enrollmentInfo":256,"targetDuration":258,"studyType":21,"phases":4,"briefSummary":259,"conditions":260,"keywords":273,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":62},"100464026","biobank-and-brain-health-in-bordeaux-100464026","NCT05322343","Biobank and Brain Health in Bordeaux.","Biobank and Brain Health in Bordeaux. A Population-based Cohort to Study the Biology of Brain and Cognitive Aging in Young Seniors","B-cube","Inclusion Criteria:\n\nFor the main study:\n\n1. live in Bordeaux metropolitan area,\n2. be between 55 and 80 years old (included),\n3. selected in terms of socioeconomic level, according to a sampling strategy by age groups and income categories representative of the general population between 55 and 80 years of age\n4. be affiliated with the social security system,\n5. agree to take a blood sample for the biobank.\n\nFor the MRI sub-study: be between 55 and 75 years old (included). Inclusion criteria for the immune response substudy: be 70 years of age or older or participate in the MRI study; agree to take a supplemental blood sample for this substudy.\n\nExclusion Criteria:\n\nFor the main study: persons under guardianship (or more generally under protection), unable to give consent to participate.\n\nFor the MRI sub-study: have a contraindication to MRI examination (pacemaker, a valve prosthesis or any other internal electrical\u002Fmagnetic device; history of neurosurgery or aneurysm; claustrophobia; presence of metal fragments in the eyes, brain or spinal cord).","55 Years","80 Years",{"count":257,"type":20},2050,"12 Months","B cube is a new generation cohort to study the determinants and natural history of brain aging, using molecular epidemiology, in a representative sample (N=2000) of the general population from the age of 55 (the approximate age of onset of the first cognitive disorders and a target population particularly receptive to prevention messages). Special interest will be given to nutrition, a promising environmental exposure for prevention.",[261,262,263,264,265,82,266,267,268,269,270,271,24,81,272],"Brain","Aging","Cognitive Aging","Immunosenescence","Mental Processes","Neurocognitive Disorders","Cognition","Brain Diseases","Dementia","Alzheimer Disease","Mental Health","Anxiety",[274,275,276,277,278,279,280,281,282,283,284,285,286],"Epidemiologic Methods","Risk factors","Public Health","Environmental Exposure","Exposome","Dietary Exposure","Diet","Food and Nutrition","Nutritional Status","Metabolomics","Systems biology","Environmental Biomarkers","Inflammation Mediators","2025-08-08",{"date":289,"type":54},"2025-08-11",{"date":291,"type":54},"2022-03-22",{"date":293,"type":20},"2030-03-22",{"name":295,"class":126},"University Hospital, Bordeaux",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":15,"minAge":304,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":73,"phases":308,"briefSummary":309,"conditions":310,"keywords":313,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":62},"100577211","wellbeing-and-resilience-among-1-3-years-old-children-of-mothers-with-complex-mental-health-problems-a-pragmatic-clinical-trial-of-online-vipp-sd-vs-care-as-usual-100577211","NCT06795347","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usual","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial","WellCom","Inclusion Criteria:\n\n* child age 1 year, 0 months until 3 years, 0 months\n* living with their mother in the Region of Southern Denmark\n* mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk\u002Fthe Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record\n* mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record\n\nExclusion Criteria:\n\n* current in-patient status of the mother\n* current substance or alcohol abuse of the mother\n* mother has insufficient knowledge of Danish (interpreter required)\n* repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child\n* known syndrome or autism spectrum disorder of the child\n* mother or child has sensory impairment\n* sibling participating in study\n* family participating in another closely related research trial receiving an individualized video-feedback intervention\n* participating in active court proceedings","1 Year","3 Years",{"count":307,"type":20},120,[111],"Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions.\n\nMental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction.\n\nTherefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention will be tested in a randomized clinical trial comparing the intervention \"Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline\" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group.\n\nThe study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father\u002Fcohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers.\n\nThe primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study.\n\nAfter baseline assessments, participants will be randomized to either intervention or the control group.\n\nThe intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review\u002Fdiscussion of the video recordings with the mother\u002Fparents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD.\n\nParticipants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.",[311,24,312],"Child Mental Health","Child of Impaired Parents",[314,315,316,317,318,319,320],"Parental psychiatric disorder","Child mental disorders","Prevention","Socio-emotional development","Child behavioral problems","Child externalizing problems","Parental sensitivity","2025-01-25",{"date":323,"type":54},"2025-01-28",{"date":325,"type":20},"2025-02",{"date":327,"type":20},"2028-01-31",{"name":329,"class":126},"University of Southern Denmark",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":15,"minAge":338,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":73,"phases":342,"briefSummary":343,"conditions":344,"keywords":350,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":62},"100484727","a-randomized-controlled-trial-on-brief-behavioral-parent-training-100484727","NCT05591820","A Randomized Controlled Trial on Brief Behavioral Parent Training","A Randomized Controlled Trial on Brief Behavioral Parent Training Versus Care as Usual in Children With Behavioral Difficulties","PAINT-GGZ","Inclusion Criteria:\n\n* The child is aged between 2 and 12 years;\n* Parents have to identify at least four behavioral difficulties of the child that occur in the home setting and that they want to target in the training, using an adapted version of a list of target behaviors (Van den Hoofdakker et al., 2007; Hornstra et al., 2021). This list contains 29 behaviors that can be targeted in the training, such as hyperactive, impulsive, inattentive, oppositional and defiant behavior. The items are derived from target problems that parents mentioned in previous behavioral parent training groups and concern child behaviors that are commonly targeted in behavioral parent training in clinical practice, confirming ecological validity (Van den Hoofdakker et al., 2007).\n\nExclusion Criteria:\n\n* The child uses psychotropic medication (currently or in the month before the screening);\n* The child has at any time received a diagnosis of autism spectrum disorder (ASD) in clinical practice, as (parents of) children with ASD may have different needs and therefore may require different treatments than children with behavioral difficulties without ASD;\n* The child has a known IQ-score below 70, as (parents of) children with intellectual disabilities may have different needs and therefore may require different treatments than children with behavioral difficulties and typical intellectual abilities;\n* Parents received behavioral parent training aimed at reducing the behavioral difficulties of the concerned child in the year prior to the start of the study;\n* It is not a suitable period for the parents and\u002For the child to participate in the study (e.g., moving, divorce);\n* The child is not living in the same household as the parent(s) who participate(s) in the trial during at least four weekdays (to ensure that our primary outcome can be reported by the same informant(s) and that parents can apply the intervention plans at home).","2 Years","11 Years",{"count":341,"type":20},93,[111],"RATIONALE: The access to and uptake of evidence-based behavioral parent training for children with behavioral difficulties (i.e., oppositional, defiant, aggressive, hyperactive, impulsive, and inattentive behavior) are currently limited because of a scarcity of certified therapists and long waiting lists. These problems are in part due to the long and sometimes perceived as rigid nature of most evidence-based programs and result in few families starting behavioral parent training and high dropout rates. Brief and individually tailored parenting interventions may reduce these problems and make behavioral parent training more accessible.\n\nOBJECTIVES: This project aims to increase the effective use of parent training for children with behavioral difficulties by (1) examining short and longer-term effectiveness of a new, brief, individual, and individually-tailored parent training program with optional booster sessions to prevent relapse, compared to care as usual (CAU); (2) assessing the cost-effectiveness of the brief parent training program compared to CAU.\n\nSTUDY DESIGN: In this two-arm, multi-center randomized controlled trial (RCT), parents are randomly assigned (1:1 ratio) to either (a) three sessions of brief behavioral parent training with optional booster sessions, or (b) CAU, as regularly provided by the involved mental healthcare centers. The study outcomes are measured at baseline before randomization (T0), one week after the third session for parents in the brief behavioral parent training arm and eight weeks after T0 for parents in the CAU arm (first posttreatment measurement, T1), six months after T1 (second posttreatment measurement, T2) and twelve months after T1 (third posttreatment measurement, T3).\n\nSTUDY POPULATION: Parents of children who experience behavioral difficulties in the home setting and were referred to a child mental healthcare center.\n\nINTERVENTION: Parents in the intervention arm receive a short, individualized, three-session training primarily aimed at reducing children's behavioral problems. It exists of two (bi)weekly individually tailored training sessions of two hours and a third session of one hour in which the training will be evaluated, and maintenance training will be provided. After that, parents wishing to receive additional support can receive single booster sessions maximum once every four weeks and\u002For receive care as usual. Parents in the control arm receive care as usual for children's behavioral problems. The treatments in both arms are fully embedded in Dutch routine mental health care.\n\nMAIN STUDY PARAMETERS: The primary outcome is the severity of four individual target behavioral difficulties that parents want to address in the training. Secondary outcomes are parent-reported behavioral difficulties, parent-reported child well-being, parent-reported parenting behaviors, masked audio records of mealtime routines to measure parent and child behavior, parent-reported parenting stress, parent-reported parenting self-efficacy, parent-reported parental attitude towards their child, consumption and cost of mental health care, and health state utility values. We furthermore measure evaluations of the program by parents and therapists and explore whether parental attachment, parental psychopathology, parental reward responsivity, parent-reported child reward responsivity and punishment sensitivity moderate the intervention effects.",[345,346,347,348,24,349],"Disruptive Behavior","Behavior Problems","Behavioral Problems","Problem Behaviors","Behavioral Difficulties",[351,352,353,354,355,345,356,357,358,359],"Parent Training","Behavioral Parent Training","Brief Parent Training","Individually-Tailored Parent Training","Booster Sessions","Children","Randomized Controlled Trial","Clinical Trial","Brief Treatment","2024-07-30",{"date":362,"type":54},"2024-07-31",{"date":364,"type":54},"2022-10-17",{"date":366,"type":20},"2026-12",{"name":368,"class":126},"Accare",{"id":370,"slug":371,"hasResults":11,"nctId":372,"briefTitle":373,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":73,"phases":376,"briefSummary":377,"conditions":378,"keywords":4,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":381,"lastUpdatePostDateStruct":382,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":387,"locationsCount":62},"100487963","the-effects-of-primary-care-behavioral-health-in-primary-care-in-sweden-100487963","NCT05633940","The Effects of Primary Care Behavioral Health in Primary Care in Sweden","Patients:\n\nInclusion Criteria, one of following:\n\n* Adult patients who seek care for mental health problems at a participating centre,\n* Adult patients who have received any following International Classification of Diseases diagnose: F00-F99, Z56, Z73\n* Adult patients who are prescribed any psychotropic drugs with ATC codes: N05A-C, N06A) at a participating centre.\n* Adult patients who has an appointment to a behavioral health consultant at a participating centre.\n\nExclusion Criteria:\n\n• Not capable to leave informed consent.\n\nMedical staff:\n\nInclusion Criteria:\n\n• Health care professionals employed at a participating centre.\n\nExclusion Criteria:\n\n• Temporarily hired personnel, e.g. hired doctors or nurses on weekly basis.",{"count":19,"type":20},[111],"The novel multi-professional service delivery model \"Primary Care Behavioural Health\" (PCBH) has been suggested as an effective way to integrate behavioural health services into routine primary care to overcome the growing problems with psychosocial and mental health problems in primary care. In this multicenter mixed-methods pragmatic clinical trial, the implementation of PCBH in routine primary health care in a region in Sweden is investigated.",[379,380,24],"Primary Health Care","Mental Disorder","2024-04-19",{"date":383,"type":54},"2024-04-23",{"date":385,"type":54},"2021-01-01",{"date":123,"type":20},{"name":388,"class":126},"Region Östergötland"]