[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249912":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":22,"responsibleParty":43,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":10,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":10,"studyType":58,"phases":10,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Irritable youth",null,"Participants meet full DMDD criteria for IBT and either full DMDD or one of two core DMDD criteria for CBT.",[13],{"name":14,"affiliation":15,"role":16},"Melissa A Brotman, Ph.D.","National Institute of Mental Health (NIMH)","PRINCIPAL_INVESTIGATOR",[18],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","(301) 435-6645","melissa.brotman@nih.gov",[23],{"facility":24,"status":25,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"National Institutes of Health Clinical Center","RECRUITING","Bethesda","Maryland","20892","United States","US",{"type":32,"coordinates":33},"Point",[34,35],-77.10026,38.98067,{"lat":35,"lon":34},[38],{"name":39,"role":19,"phone":40,"phoneExt":41,"email":42},"For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":44,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100249912","psychological-treatments-for-youth-with-severe-irritability-100249912",false,"NCT02531893","Psychological Treatments for Youth With Severe Irritability.","Psychological Treatments for Youth With Severe Irritability","* INCLUSION CRITERIA:\n\nInclusion criteria for both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. Age 8-17 years\n2. Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.\n3. Must meet DSM 5 diagnostic criteria for DMDD which are (for CBT, must meet lifetime history of either DMDD or one of two core DMDD criteria \\[b or c\\]):\n\n   * Must meet all of the following:\n\n     1. Diagnosis must first be made between ages 6-18 years\n     2. Abnormal mood (specifically, anger and\u002For irritability), present at least half of the day most days, and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers).\n     3. Compared to his\u002Fher peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest 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. Such events occur, on average, at least three times a week.\n   * The symptoms in b and c above are currently present and have been present for at least 12 months without any symptom-free periods exceeding two months.\n   * The onset of symptoms must be prior to age 10 years.\n   * The symptoms are severe in at least one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers). In addition, there are at least mild symptoms (verbal aggression) in a second setting.\n4. Patients must be fluent in English\n\n   1. All instruments have not been validated in other languages.\n   2. Psychotherapy will be designed and conducted in English.\n5. 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).\n6. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and\u002For psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.\n\nEXCLUSION CRITERIA:\n\nExclusion criteria both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:\n\n1. The individual exhibits any of these cardinal bipolar symptoms:\n\n   1. Elevated or expansive mood.\n   2. Grandiosity or inflated self-esteem.\n   3. Decreased need for sleep.\n   4. Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).\n   5. A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.\n2. Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.\n3. IQ\\\u003C70\n4. The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.\n5. Meets criteria for alcohol or substance abuse three months prior to enrollment.\n6. Meets DSM 5 criteria for current major depressive disorder. The rationale for the exclusion of youth with MDD is because the two novel interventions being tested are contraindicated for those with major depressive disorder. However, there is no contraindication to participation for those with treated\u002Fresolved or remitted major depressive disorder; only those with a current diagnosis need to be excluded.","ALL","8 Years","17 Years",{"count":56,"type":57},200,"ESTIMATED","OBSERVATIONAL","Background:\n\nWhen children have severe irritability and temper outbursts, they can be so cranky or angry that it leads to problems at home, in school, and with friends. This is called Disruptive Mood Dysregulation Disorder (DMDD) and there have been no psychological treatments developed specifically for children with this problem. Researchers think two forms of therapy, Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT), might help children with DMDD.\n\nObjective:\n\nTo test two whether IBT and CBT can decrease severe irritability in children and youth.\n\nEligibility:\n\nChildren 8-17 years old with DMDD. Their symptoms must have started before age 10.\n\nDesign:\n\nParticipants will be screened with a review of their symptoms. Parents and participants will answer questions.\n\nParticipants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.\n\nParticipants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.\n\nParticipants will talk about what makes them irritable and how it affects them. They may be put in situations that might make them annoyed or irritable.\n\nParticipants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.\n\nParticipants will do practice activities at home.\n\nParticipants doing IBT will have up to 14 sessions over 10 weeks.\n\nParticipants will view 15 faces, one at a time, on a computer. They will choose if the face looks happy or angry on a computer. Sometimes the computer gives feedback. Participants will complete some sessions at the NIH and some at home.\n\nParticipants and parents answer questions about their progress.",[61],"Irritability",[63,64,65,66],"Interpretation Bias Training","Cognitive Behavioral Therapy","Children","Natural History","2026-07-01",{"date":69,"type":70},"2026-07-02","ACTUAL",{"date":72,"type":70},"2015-11-17",{"date":74,"type":57},"2028-05-08",{"name":15,"class":6},1]