[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"oppositional-defiant-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:oppositional-defiant-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,52,64,101,126,156,184,214,240,268,289,306,338,360,379],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"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":20,"type":21},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.",[25,26,27,28],"Irritability","Disruptive Mood Dysregulation Disorder","Oppositional Defiant Disorder","Attention Deficit Hyperactivity Disorder",[25,30,31,32,33,34,35,36,37,38],"Parent Management Training","Psychosocial Treatment","Exposure Therapy","Children","ANGER","Pediatric","Cognitive Behavioral Therapy","Psychoeducation","Supportive Therapy","NOT_YET_RECRUITING","2026-07-10",{"date":42,"type":43},"2026-07-13","ACTUAL",{"date":45,"type":21},"2026-07-16",{"date":47,"type":21},"2037-12-31",{"name":49,"class":50},"National Institute of Mental Health (NIMH)","NIH",1,{"id":53,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":55,"keywords":56,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":63,"locationsCount":51},"100641449",{"count":20,"type":21},[25,26,27,28],[25,30,31,32,33,34,35,36,37,38],"2026-07-01",{"date":59,"type":43},"2026-07-02",{"date":61,"type":21},"2026-07-07",{"date":47,"type":21},{"name":49,"class":50},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":16,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":51},"100596199","testing-a-measurement-feedback-app-to-improve-data-quality-supervision--outcomes-in-behavioral-health-100596199","NCT07042347","Testing a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health","RCT of a Measurement Feedback App to Improve Data Quality, Supervision & Outcomes in Behavioral Health","Footsteps","Inclusion Criteria:\n\n* Aides must be working with at least one client in school who meets the following criteria: 1) between 3-17 years, 2) has a diagnosis associated with a challenging behavior (e.g., autism spectrum disorder, attention deficit hyperactivity disorder, oppositional defiant disorder) as indicated on their treatment plan, and 3) receiving 1:1 aide support.\n* Supervisors must be employed by a community behavior health agency and supervise a participating aide. The investigators will recruit supervisors in dyads and not triads (i.e., no supervisors with two \\[or more\\] aides) to ensure there are 30 supervisor-aide dyads in total).\n\nExclusion Criteria:\n\n* Aides who participated in the pilot trial of the Footsteps will be excluded from participating to recruit a sample naïve to Footsteps and the control app.",true,"18 Years",{"count":75,"type":21},200,"INTERVENTIONAL",[78],"NA","The goal of this clinical trial is to test whether a smartphone-based data collection and feedback application (\"Footsteps\") improves the quality of behavioral data collected by one-to-one aides and leads to better youth mental health outcomes in school-aged youth (ages 4-17) who receive one-to-one support in schools.\n\nThe main questions it aims to answer are:\n\n1. Does the Footsteps app improve aides' data collection quality (i.e., consistency, timeliness, and completeness)?\n2. Does Footsteps use lead to improved youth behavioral health outcomes (e.g., SDQ, YTP scores)?\n3. Does Footsteps improve communication and supervision processes between aides and clinical supervisors?\n\nResearchers will compare aides using Footsteps to those using a \"data collection only\" control app to see if Footsteps leads to higher quality data collection, enhanced supervisory communication, and better youth outcomes.\n\nParticipants will:\n\n* Use either Footsteps or a control app to record de-identified data on one client's behaviors and skills over 12 weeks\n* Complete biweekly online surveys about data collection experiences, youth progress, and aide-supervisor communication\n* Participate in a virtual intake and post-trial meeting\n* (For a subset) Participate in a 30-45 minute qualitative interview about their experience using the app",[81,82,83,27],"Autism","Challenging Behavior","ADHD",[85,86,87,88,89],"data collection","Behavioral Health Technician (BHT)","behavioral economics","implementation science","supervisory processes","RECRUITING","2026-05-07",{"date":93,"type":43},"2026-05-08",{"date":95,"type":43},"2026-04-08",{"date":97,"type":21},"2028-06-30",{"name":99,"class":100},"University of Pennsylvania","OTHER",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":108,"maxAge":18,"enrollmentInfo":109,"targetDuration":4,"studyType":76,"phases":111,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":51},"100579963","phase-1-pathways-2-success-100579963","NCT06831123","Pathways 2 Success","Pathways 2 Success: A Study of School-Based Prevention Programs Supporting Positive Adolescent Development","Inclusion Criteria:\n\n1. A 9th or 10th grade student in a partner school district\n2. Referral due to elevated social\u002Femotional risk indicated on a standardized screening tool or a referral from school support staff due to concerns about school-based conduct problems\n3. Adolescents and their parents must be fluent in English\n\nExclusion Criteria:\n\n1. Currently receiving special education services (i.e., an IEP) due to a behavioral or emotional disturbance\n2. Existing diagnoses of autism spectrum disorder, pervasive developmental disorders, developmental\u002Fintellectual disability, or serious psychiatric disorders requiring specialized mental health treatment (e.g., psychosis, bipolar, substance use disorder, etc.)","13 Years",{"count":110,"type":21},120,[112,113],"PHASE1","PHASE2","This study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. High school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. Assessments related to intervention outcomes will be completed by adolescents, parents\u002Fguardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.",[116,27],"Conduct Disorder","2026-04-09",{"date":119,"type":43},"2026-04-13",{"date":121,"type":43},"2025-03-12",{"date":123,"type":21},"2027-02-28",{"name":125,"class":100},"University of Minnesota",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":76,"phases":136,"briefSummary":137,"conditions":138,"keywords":142,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":51},"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.","6 Years","12 Years",{"count":75,"type":21},[78],"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.",[139,140,141,28,116,27],"Disruptive Behavior Disorder","Emotional Disorder","Behavioural Disorder",[143,144,28,116,27,145,146],"Emotional and Behavioural Disorders","Disruptive Behaviour Disorder","Parenting Skills","Behavioural Parenting Training","2026-03-16",{"date":149,"type":43},"2026-03-17",{"date":151,"type":43},"2022-10-01",{"date":153,"type":21},"2027-09",{"name":155,"class":100},"Centre for Addiction and Mental Health",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":73,"enrollmentInfo":163,"targetDuration":4,"studyType":76,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":51},"100628053","actsocially-the-dissimilarities-of-act-for-changing-internalizing-and-externalizing-symptomatology-in-adolescence-100628053","NCT07456631","ACTsocially: The (Dis)Similarities of ACT for Changing Internalizing and Externalizing Symptomatology in Adolescence","ACTsocially","Inclusion Criteria:\n\nStudy I:\n\n* Main diagnosis of Oppositional Defiant Disorder (ODD)\n* Meeting diagnostic criteria for Social Anxiety Disorder (SAD)\n\nStudy II:\n\n* Main diagnosis of Social Anxiety Disorder (SAD)\n* Meeting diagnostic criteria for Oppositional Defiant Disorder (ODD)\n\nExclusion Criteria (applies to both studies):\n\n* Impaired cognitive development based on school records\n* Presence of psychotic symptoms according to the diagnostic interview\n* Diagnosis of autism spectrum disorder according to the diagnostic interview\n* Currently undergoing another psychological intervention for a psychiatric condition\n\nNote: Comorbid conditions other than the co-occurrence of ODD and SAD will not be considered exclusion criteria.",{"count":164,"type":21},54,[78],"Social functioning, fundamental to adolescent's development and mental health, may be impaired by polarizing problematic social functioning, namely externalizing symptoms manifested by Oppositional Defiant Disorder and internalizing symptoms portrayed by Social Anxiety Disorder. Despite their high prevalence and similar associated impairments, interventions targeting these disorders are differently conceived. Alternatively, Acceptance and Commitment Therapy (ACT) proposes that those apparently dissimilar social difficulties are rooted in similar processes. Though research has shown ACTs' efficacy in changing adults' internalizing and externalizing symptoms, studies on the potential of ACT in changing those problematics in adolescence are still scarce. This project proposes to conduct three clinical trials to test the efficacy and (dis)similarities of an transdiagnostic ACT intervention for changing internalizing and externalizing symptomatology in adolescents. It will amplify the transdiagnostic and evidence-based application of ACT to adolescents presenting polarizing disorders in the social functioning spectrum.",[168,27],"Social Anxiety Disorder (SAD)",[170,171,27,172,173,174],"Acceptance and Commitment Therapy","Adolescents","Social Anxiety Disorder","Psychological Flexibility","Psychological Inflexibility","2026-03-06",{"date":177,"type":43},"2026-03-10",{"date":179,"type":43},"2023-09-01",{"date":181,"type":21},"2027-09-30",{"name":183,"class":100},"University of Coimbra",{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":76,"phases":194,"briefSummary":195,"conditions":196,"keywords":202,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":51},"100585460","step-by-step-evaluation-of-a-stepped-care-model-100585460","NCT06902649","Step-by-Step: Evaluation of a Stepped Care Model","Step-by-Step: Evaluation of a Stepped Care Model for Anger, Defiant, or Aggressive Behavior in Children and Adolescents","Inclusion Criteria:\n\n* Families with children aged 8-16 years who have difficulty controlling anger or exhibit defiant or aggressive behavior. The child\u002Fadolescent meets 3 of the diagnostic criteria for Oppositional Defiant Disorder or 2 criteria for Conduct Disorder indicating aggressive behavior.\n* Medication for the child can remain stable.\n* Parents need to be able to read and engage with materials in Swedish\n\nExclusion Criteria:\n\n* Families with children younger than 8 years old or who have already turned 17, or who do not exhibit defiant or aggressive behaviors according to the first inclusion criterion.\n* Children with severe depression, suicidal behavior, bipolar disorder, psychosis, eating disorders, severe autism (level 2 and 3), diagnosed intellectual disability, or ongoing criminal behavior assessed to require interventions other than the study's interventions are excluded.\n* Children\u002Fadolescents with other ongoing psychological treatments for the same condition or assessed by the clinician in need of other interventions\n* Parents and children with epilepsy or migraines","16 Years",{"count":193,"type":21},210,[78],"The primary aim of this project is to examine the effectiveness of a stepped care model of interventions for children's defiant or aggressive behavior problems. The stepped model consists of a brief internet-based parenting support program (Step 1). For those with continued need of additional interventions, Step 2 includes access to one of following interventions: b) a Cognitive Behavior Therapy (CBT) -Virtual Reality (VR)-assisted parenting support program, b) a Cognitive Behavior Therapy -Virtual Reality-assisted child intervention, or c) standard interventions\u002Fsupport at the family's unit\u002Fclinic and continued access to the study's internet-based parenting support program, after which the family may choose CBT-VR for the child or the parent.",[197,198,27,199,200,201],"Child Behavior Problem","Disruptive Behavior","Conduct Problems","Aggression","Anger",[198,197,203,204,205],"Cognitive behavior therapy","Virtual Reality","Parenting support program","2026-03-04",{"date":175,"type":43},{"date":209,"type":43},"2025-04-02",{"date":211,"type":21},"2027-08-31",{"name":213,"class":100},"Karolinska Institutet",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":4,"studyType":76,"phases":224,"briefSummary":225,"conditions":226,"keywords":228,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":236,"leadSponsor":238,"locationsCount":239},"100608402","effects-and-implementation-of-a-brief-version-of-parent-child-interaction-therapy-100608402","NCT07201090","Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy","Effects and Implementation of a Brief Version of Parent-Child Interaction Therapy, Supplemented by Videos and Virtual Reality-films","Inclusion Criteria:\n\n* Child aged 2-7 years\n* Elevated disruptive behavior (ECBI score \\>114)\n* Parent speaks Swedish or English\n\nExclusion Criteria:\n\n* Child or family requiring more urgent intervention\n* Parent condition that prevents VR use (e.g., epilepsy, severe migraine, adverse VR experiences)","2 Years","7 Years",{"count":5,"type":21},[78],"The aim of this study is to evaluate the effects and feasibility of a shortened version of Parent-Child Interaction Therapy (PCIT), supplemented with video vignettes of parenting skills and 360-virtual reality (VR)-films for parents of children aged 2-7 years with disruptive behavior problems. The main questions the study aims to answer, using a Single-Case Experimental Design, are:\n\n1. How feasible and acceptable is the implementation of brief PCIT-VR in Sweden?\n2. What are the preliminary effects of brief PCIT-VR?\n3. How do parents and clinicians experience brief PCIT-VR?\n\nFamilies at child and adolescent psychiatry clinics will receive up to 10 PCIT sessions. Caregivers complete quantitative assessments before, during, after treatment, and at 6-months follow-up, and are asked to participate in interviews after PCIT. Feasibility and acceptability of brief PCIT VR is evaluated, as well as effectiveness outcomes, including changes in child disruptive behavior and parenting skills. Within-group analyses will examine trends in outcome measures over time.",[227,198,27],"Conduct Disorders in Children",[229,230,231],"Parent training","Parent-Child Interaction Therapy","Virtual reality","2025-09-29",{"date":234,"type":43},"2025-10-01",{"date":234,"type":21},{"date":237,"type":21},"2026-12-31",{"name":213,"class":100},2,{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":134,"maxAge":248,"enrollmentInfo":249,"targetDuration":4,"studyType":76,"phases":251,"briefSummary":252,"conditions":253,"keywords":255,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":264,"leadSponsor":266,"locationsCount":51},"100606928","is-mentalization-based-therapy-more-effective-than-treatment-as-usual-for-adolescents-with-dissocial-disorders-100606928","NCT07181928","Is Mentalization-based Therapy More Effective Than Treatment-as-usual for Adolescents With Dissocial Disorders?","Is Mentalization-based Therapy More Effective for Adolescents With Disruptive and Dissocial Disorders Than TAU-plus (Emotion-focused Parent Training With Supportive Child Psychiatric Care)?","MEDAL","Inclusion Criteria:\n\n* Primary diagnosis of Oppositional defiant disorder (ODD) \u002F Conduct-dissocial disorder (CDD) (ICD-11: 6C90-6C91; ICD-10: F91.0-F91.9; DSM-5: 312.81, 313.81)\n* Aged 12 to 19 years\n* Living with their parents\n* Provide written informed consent (plus parental consent for minors)\n* At least one parent provides written informed consent and agrees to active participation in treatment and study, including randomization\n\nExclusion Criteria:\n\n* Severe acute substance dependence requiring inpatient detoxification\n* Acute psychotic symptoms or early-onset schizophrenia\n* Neurological impairments or intellectual disability (IQ \\\u003C 80)\n* Insufficient proficiency in German\n* Other clinical contraindications for outpatient psychotherapy (e.g., acute suicidality)","19 Years",{"count":250,"type":21},90,[78],"The goal of this clinical trial is to investigate if Mentalization-based therapy (MBT) is superior to enhanced usual care (treatment-as-usual-plus (TAU-plus)) for adolescents with disruptive behavior or dissocial disorders.\n\nMBT is an intervention that aims to improve mentalizing. Mentalizing is the ability to reflect on mental states in oneself and others that motivate behavior. TAU-plus consists of psychiatric care for the adolescent, along with additional emotion-focused skills training for the parents.\n\nParticipants will be randomized in one of two groups using one study center.",[254,27],"Conduct Disorders in Adolescence",[256,257,116,258,259],"Adolescence","MBT","Externalizing behaviour disorders","Treatment-as-usual","2025-09-16",{"date":262,"type":43},"2025-09-18",{"date":234,"type":21},{"date":265,"type":21},"2028-08-31",{"name":267,"class":100},"University Hospital Heidelberg",{"id":269,"slug":270,"hasResults":11,"nctId":271,"briefTitle":272,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":274,"targetDuration":4,"studyType":76,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":51},"100547632","digital-dyadic-family-based-intervention-to-improve-sleep-in-children-with-odd-and-their-parents-nitecapp-sincc-pilot-100547632","NCT06410495","Digital Dyadic Family Based Intervention to Improve Sleep in Children with ODD and Their Parents: NiteCAPP SINCC (Pilot)","Inclusion criteria:\n\n1. Child ages 8-17 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child\u002Fparent participation in another randomized research project\n4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment\n5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation",{"count":275,"type":21},30,[78],"In this proposal a brief web-based cognitive behavioral treatment for insomnia (CBT-I) for children with oppositional defiant disorder (ODD) and their parents is iteratively adapted and tested for acceptability, feasibility, and preliminary efficacy.",[27,279],"Insomnia Chronic","2025-03-24",{"date":282,"type":43},"2025-03-28",{"date":284,"type":43},"2024-05-01",{"date":286,"type":21},"2025-12-01",{"name":288,"class":100},"University of South Florida",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":134,"enrollmentInfo":296,"targetDuration":4,"studyType":76,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":305,"locationsCount":51},"100543009","sleep-cope-sleep-intervention-for-oppositional-children-100543009","NCT06350292","SLEEP-COPE: Sleep Intervention for Oppositional Children","SLEEP-COPE: Sleep Enhancement and Effective Parenting for Children with Oppositional and Problematic Expressions","Inclusion criteria:\n\n1. Child ages 8-12 with ODD (prior diagnosis) and insomnia\n2. Child and parent English proficiency.\n\nInsomnia:\n\n1. complaints of difficulties falling asleep, staying asleep, or early morning awakening by child report or parent observation for 3+ mos\n2. daytime dysfunction (mood, cognitive, social, academic) due to insomnia\n3. baseline diaries and actigraphy indicate \\>30 mins. of sleep onset latency, wake after sleep onset, or early morning awakening (time between last awakening and out of bed time) on 6+ nights\n\nExclusion criteria:\n\n1. Parent unable to provide informed consent or child unable to provide assent\n2. Family unwilling to accept random assignment\n3. Child\u002Fparent participation in another randomized research project\n4. Parent unable to complete forms or implement treatment procedures due to cognitive impairment\n5. Child untreated medical comorbidity, including other sleep disorders (e.g., apnea, epilepsy, psychotic disorders, suicidal ideation\u002Fintent, \\[frequent\\] parasomnias)\n6. Child psychotropic or other medications that alter sleep with the exceptions of stimulants, sleep medications, and\u002For melatonin\n7. Child participation in non-pharmacological treatment (including CBT) for sleep outside current trial\n8. Parent report of inability to undergo Holter Monitoring or actigraphy (e.g., extreme sensitivity, behavioral outbursts)\n9. Other conditions adversely affecting trial participation",{"count":297,"type":21},25,[78],"Children with Oppositional Defiant Disorder (ODD) are at risk for insomnia, arousal dysfunction, mood problems, and noncompliance. Cognitive behavioral treatment for insomnia (CBT-I) holds promise for improving insomnia and related concerns. Telehealth delivery will reduce the burden of in-person sessions, particularly in areas where there is low mental healthcare access. Telehealth CBT-I is efficacious in adults and children but has not been tested in children with ODD. The proposed trial is the next logical step - development and iterative testing of SLEEP-COPE, a brief dyadic telehealth CBT-I for children with ODD and their parents.",[279,27],{"date":282,"type":43},{"date":303,"type":43},"2024-04-01",{"date":234,"type":21},{"name":288,"class":100},{"id":307,"slug":308,"hasResults":11,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":76,"phases":316,"briefSummary":317,"conditions":318,"keywords":325,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":334,"leadSponsor":336,"locationsCount":239},"100488223","big-feelings-a-study-on-childrens-emotions-in-therapy-100488223","NCT05637320","Big Feelings: A Study on Children's Emotions in Therapy","Biobehavioural Regulation of Negative Emotion as a Transdiagnostic Mechanism of Children's Psychotherapy","Inclusion Criteria:\n\n* Child must be between the ages of 8 and 15 years old and have English proficiency\n* Parents must be over the age of 18 and have English proficiency\n* Must be seeking psychosocial treatment for concerns related to anxiety, depression, or disruptive behaviours\n\nExclusion Criteria:\n\n* Child has low cognitive functioning that would prevent active participation in research tasks\n* Child reports active suicidality that requiring acute care or hospital intervention\n* Child meets criteria for psychosis, schizophrenia spectrum disorders, eating disorders or autism spectrum disorders\n* Child does not assent to participate in the study","15 Years",{"count":315,"type":21},202,[78],"The goal of this clinical trial is to learn about how psychotherapy works for children and adolescents aged 8 - 15 with anxiety, depression, trauma, or disruptive behaviour. The main question it aims to answer is:\n\n• Is the biobehavioural regulation of negative emotion a transdiagnostic mechanism of treatment response in psychotherapy for children with anxiety, depression, trauma and\u002For disruptive behaviour?\n\nChildren and their parents will be randomly assigned to an evidence-based, transdiagnostic treatment (the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems; MATCH-ADTC) or a waitlist control condition. Participants in both groups will complete a baseline assessment, weekly measures consisting of brief symptom scales and medication tracking, and quarterly assessments every 3 months. Following the intervention\u002Fwaitlist period, our team will conduct post-test assessments. All assessments, except for the weekly surveys, will consist of symptom scales, clinical interviews, experimental tasks and physiological measures.",[319,320,321,116,27,322,323,324],"Anxiety Disorders","Depressive Disorder","Mood Disorders","Regulation, Emotion","Child Behavior Disorders","Trauma and Stressor Related Disorders",[326,327,328,329],"Child psychotherapy","Emotion regulation","Physiology","Mechanism of change","2025-01-27",{"date":332,"type":43},"2025-01-29",{"date":151,"type":43},{"date":335,"type":21},"2027-12-31",{"name":337,"class":100},"University of Guelph",{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":191,"enrollmentInfo":345,"targetDuration":4,"studyType":76,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":357,"leadSponsor":359,"locationsCount":4},"100559106","pilot-study-of-parent-training-with-role-plays-in-virtual-reality-for-parents-of-children-with-behavior-problems-100559106","NCT06559813","Pilot Study of Parent Training With Role-plays in Virtual Reality for Parents of Children With Behavior Problems","Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Parents of Children With Anger, Oppositional or Aggressive Behaviors","INCLUSION CRITERIA:\n\nParents:\n\n* Parent of a child aged 8-16 years\n* The parent perceives that the child has oppositional, angry or aggressive behaviors, and\u002For that there are parent-child conflicts at home.\n* The child's behavior is elevated on a measure targeting behavioral problems (SDQ conduct problems subscale)\n\nEXCLUSION CRITERIA\n\nParent treatment:\n\n* Parent of a child under 8 years or over 16 years of age\n* The child does not currently exhibit oppositional, angry or aggressive behaviors\n* Child diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors\n* Parent has epilepsy or migraine",{"count":346,"type":21},10,[78],"The main aim of this pilot trial is to evaluate preliminary effects and feasibility of a new parent training program for parents of children aged 8-16 years with disruptive behavior (e.g., angry, aggressive or defiant behavior). The parent training program is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR).\n\nThe main questions the project aims to answer are:\n\n* What are the preliminary effects of the CBT-VR parent training program?\n* What is the level of parent engagement in the CBT-VR parent training program?\n* What are the experiences of parents and therapists of the CBT-VR parent training program?\n\nThe CBT-VR parenting program is delivered at clinics during individual sessions. Parents will answer quantitative measurements before, during, and after treatment. Within-group analyses will be conducted to examine experiences and preliminary effects of the program. Parents and clinicians are also asked to participate in a qualitative interview after the program has ended.",[197,198,27,199,200,350],"Parent-Child Relations",[198,197,352,204],"Parenting","2024-08-15",{"date":355,"type":43},"2024-08-19",{"date":355,"type":21},{"date":358,"type":21},"2024-11-30",{"name":213,"class":100},{"id":361,"slug":362,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":4,"eligibilityCriteria":366,"healthyVolunteers":11,"sex":16,"minAge":367,"maxAge":191,"enrollmentInfo":368,"targetDuration":4,"studyType":76,"phases":369,"briefSummary":370,"conditions":371,"keywords":372,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":375,"startDateStruct":376,"completionDateStruct":377,"leadSponsor":378,"locationsCount":4},"100559105","pilot-study-of-cognitive-behavior-therapy-with-role-plays-in-virtual-reality-for-children-with-behavior-problems-100559105","NCT06559800","Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Behavior Problems","Step by Step - Pilot Study of Cognitive Behavior Therapy With Role-plays in Virtual Reality for Children With Anger, Oppositional or Aggressive Behaviors","Inclusion Criteria:\n\n* Child\u002Fyouth aged between 10-16 years with increased levels of anger or disruptive behaviors,\n* The child's behavior problems is elevated on questions targeting behavioral problems (SDQ conduct problems subscale).\n\nExclusion Criteria:\n\n* Child\u002Fyouth is below 10 years or above 16 years of age\n* No increased levels of anger or disruptive behaviors\n* Child\u002Fyouth is diagnosed with autism, serious depression, psychosis, eating disorder, or self-harm behaviors\n* Child\u002Fyouth has epilepsy or migraine","10 Years",{"count":346,"type":21},[78],"The main aim of this small pilot trial is to evaluate preliminary effects and feasibility of the child intervention YourSkills for child disruptive behavior (e.g., enhanced anger or aggressive behavior) when evaluated in Sweden for children\u002Fyouth aged 10-16 years. YourSkills is based on cognitive behavioral therapy (CBT) and includes practicing of skills in virtual reality (VR).\n\nThe main questions the project aims to answer are:\n\n* What are the preliminary effects of the child\u002Fyouth CBT-VR-program?\n* What is the level of child\u002Fyouth engagement in the CBT-VR program?\n* What are the experiences of parents, children\u002Fyouth and therapists of the program?\n\nThe CBT-VR program is delivered at clinics during ten individual sessions. Parents will answer quantitative measurements before and after treatment, children will answer quantitative measurements before, during and after treatment. Within- group analyses will be conducted to examine experiences and preliminary effects of the program. Parents, children and clinicians are also asked to participate in a qualitative interview after the program has ended.",[197,198,27,199,200,201],[373,374,203,231],"Disruptive behavior","Child behavior problems",{"date":355,"type":43},{"date":355,"type":21},{"date":358,"type":21},{"name":213,"class":100},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":4,"eligibilityCriteria":385,"healthyVolunteers":72,"sex":16,"minAge":133,"maxAge":134,"enrollmentInfo":386,"targetDuration":4,"studyType":76,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":51},"100531069","emotion-regulation-as-a-moderator-of-two-different-treatments-for-children-with-odd-100531069","NCT06194994","Emotion Regulation as a Moderator of Two Different Treatments for Children With ODD","Emotion Regulation as a Moderator of Two Different Treatments for Children With Oppositional Defiant Disorder: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Diagnosed with Oppositional Defiant Disorder\n* Icelandic speaking (child and parent\u002Fguardian)\n\nExclusion Criteria:\n\n* IQ below 70 (full scale score)",{"count":387,"type":21},196,[78],"The goal of this randomized controlled trial is to is to test emotion regulation as a moderator of two different treatments for children with Oppositional Defiant Disorder (ODD). The main question it aims to answer is whether treatment gains be increased when children with ODD receive a treatment congruent with their emotion regulation skill problems. Participants will be divided into two groups based on their response patterns; a high emotion dysregulation group and a low emotion dysregulation group. Within each group, children will then be randomly assigned to either a behavioral parent training intervention or a child directed treatment involving problem solving and emotion regulation skills.",[27],[27,392,393],"Emotion Regulation","Child Psychopathology","2024-01-05",{"date":396,"type":43},"2024-01-08",{"date":398,"type":43},"2024-01-04",{"date":400,"type":21},"2029-12",{"name":402,"class":100},"University of Iceland"]