Actively Recruiting

Age: 8Years - 17Years
All Genders
NCT02531893

Psychological Treatments for Youth With Severe Irritability.

Led by National Institute of Mental Health (NIMH) · Updated on 2026-05-07

200

Participants Needed

1

Research Sites

650 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: 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. Objective: To test two whether IBT and CBT can decrease severe irritability in children and youth. Eligibility: Children 8-17 years old with DMDD. Their symptoms must have started before age 10. Design: 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. ...

CONDITIONS

Official Title

Psychological Treatments for Youth With Severe Irritability.

Who Can Participate

Age: 8Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 8 and 17 years
  • Enrolled in NIMH DIRP protocol 02-M-0021
  • Meet DSM-5 criteria for DMDD with symptoms starting before age 10
  • Abnormal mood with anger or irritability present most days, noticeable to others
  • Markedly increased reactivity to negative emotions, occurring at least three times a week
  • Symptoms present for at least 12 months without symptom-free periods over two months
  • Severe symptoms in at least one setting and mild symptoms in a second setting
  • Fluent in English
  • Minimal response to current treatment (CGI-S score of 3 or more)
  • No planned changes in psychiatric treatment two weeks before and during study periods
Not Eligible

You will not qualify if you...

  • Presence of bipolar symptoms such as elevated mood, grandiosity, decreased need for sleep, or increased goal-directed activity
  • History of hypomanic or manic episodes lasting more than one day
  • Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or PTSD
  • IQ less than 70
  • Symptoms caused by drug abuse or medical/neurological conditions
  • Alcohol or substance abuse within three months prior to enrollment
  • Current diagnosis of major depressive disorder

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

M

Melissa A Brotman, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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