Clinical trial Recruiting at 1 site Observational Ages 8 to 17

Psychological treatments for children with severe irritability

Official title: Psychological Treatments for Youth With Severe Irritability

Run by National Institutes of Health Clinical Center (CC) · NCT02531893 · Data updated 2026-11-12

This study is testing two types of therapy to see if they can help kids and teens with severe irritability feel better.

Quick facts

Study typeObservational
Ages8 Years to 17 Years
SexAll
Enrollment200 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedNovember 17, 2015
Main results expectedMay 8, 2028
Study endsMay 8, 2028
Registry record updatedNovember 9, 2026
Trial IDNCT02531893 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children aged 8-17 who have been diagnosed with DMDD and exhibit symptoms that began before age 10.

Probably not a fit

Patients who do not meet the diagnostic criteria for DMDD or are outside the age range of 8-17 may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of two psychological treatments, Interpretation Bias Training (IBT) and Cognitive Behavioral Therapy (CBT), for children and youth aged 8-17 diagnosed with Disruptive Mood Dysregulation Disorder (DMDD). Participants will undergo screening to assess their symptoms, and they can choose to participate in one or both treatments. The IBT involves computer-based training to alter emotional judgments, while the CBT consists of 12-16 weekly therapy sessions. The study will measure changes in irritability through parent and clinician assessments.

Why it matters

Potential benefit: If successful, this study could provide effective non-pharmacological treatment options for children suffering from severe irritability.

How similar studies have gone: Other studies have shown promise in using psychological treatments for similar conditions, but this specific approach is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
* INCLUSION CRITERIA:

Inclusion criteria for both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:

1. Age 8-17 years
2. Must be enrolled into NIMH DIRP protocol 02-M-0021, Characterization and Pathophysiology of Severe Mood and Behavioral Dysregulation in children and youth.
3. 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 \[b or c\]):

   * Must meet all of the following:

     1. Diagnosis must first be made between ages 6-18 years
     2. Abnormal mood (specifically, anger and/or 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).
     3. Compared to his/her 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/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week.
   * 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.
   * The onset of symptoms must be prior to age 10 years.
   * 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.
4. Patients must be fluent in English

   1. All instruments have not been validated in other languages.
   2. Psychotherapy will be designed and conducted in English.
5. On the basis of record review and interviews with child and parent, the research team agrees that the child s response to his/her current treatment is no more than minimal (i.e. CGI-S of 3 or more).
6. Must have no planned changes in outpatient psychiatric treatment regimen, which can include psychotropic medications and/or psychotherapeutic interventions, two weeks prior to enrollment and throughout the three weeks of training and post-training assessment.

EXCLUSION CRITERIA:

Exclusion criteria both Interpretation Bias Training and Cognitive Behavioral Therapy Studies:

1. The individual exhibits any of these cardinal bipolar symptoms:

   1. Elevated or expansive mood.
   2. Grandiosity or inflated self-esteem.
   3. Decreased need for sleep.
   4. Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences).
   5. A history of hypomanic or manic symptoms that occurred in distinct episodes lasting more than 1 day.
2. Meets DSM 5 criteria for schizophrenia, schizophreniform disorder, schizoaffective illness, Autism Spectrum Disorder, or posttraumatic stress disorder.
3. IQ\<70
4. The symptoms are due to the direct physiologic effects of a drug of abuse, or to a general medical or neurological condition.
5. Meets criteria for alcohol or substance abuse three months prior to enrollment.
6. 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/resolved or remitted major depressive disorder; only those with a current diagnosis need to be excluded.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Melissa A Brotman, Ph.D. — National Institute of Mental Health (NIMH)
  • Study coordinator: Melissa A Brotman, Ph.D.
  • Email: melissa.brotman@nih.gov
  • Phone: (301) 435-6645

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.