Psychological Treatments for Youth With Severe Irritability.
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|ClinicalTrials.gov Identifier: NCT02531893|
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : April 12, 2021
When 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.
To test two whether IBT and CBT can decrease severe irritability in children and youth.
Children 8-17 years old with DMDD. Their symptoms must have started before age 10.
Participants will be screened with a review of their symptoms. Parents and participants will answer questions.
Participants can do only one or both of these treatments if they wish. Those who wish to do both will start with IBT.
Participants who do CBT will have 12-16 weekly meetings of research talk therapy. A parent will participate in part of the sessions.
Participants 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.
Participants will rate how intense their irritability is. Parents and participants will complete rating scales, questionnaires, and interviews.
Participants will do practice activities at home.
Participants doing IBT will have up to 14 sessions over 10 weeks.
Participants 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.
Participants and parents answer questions about their progress.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Psychological Treatments for Youth With Severe Irritability.|
|Actual Study Start Date :||November 17, 2015|
|Estimated Primary Completion Date :||May 8, 2022|
|Estimated Study Completion Date :||May 8, 2022|
Participants meet full DMDD criteria for IBT and either full DMDD or one of two core DMDD criteria for CBT.
- Clinical Global Impression--Improvement score [ Time Frame: Every two weeks ]Clinician administered measure to assess clinical symptoms
- Affective Reactivity Index (ARI) [ Time Frame: Every two weeks ]Clinician administered measure to assess clinical symptoms
- parent and self-report measures of depression, anxiety, anger, social status, and aggression, as well as clinician ratings of depression, anxiety, and impairment [ Time Frame: weekly ]Self- and parent-report measures to assess clinical symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531893
|Contact: Melissa A Brotman, Ph.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Melissa A Brotman, Ph.D.||National Institute of Mental Health (NIMH)|