New hope for chronically cranky kids: therapy trial targets severe temper outbursts
NCT ID NCT02531893
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 15 times
Summary
This study tests two psychological treatments—Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT)—for children aged 8 to 17 with severe irritability and temper outbursts, a condition called Disruptive Mood Dysregulation Disorder (DMDD). Participants will receive up to 16 weekly CBT sessions or up to 14 IBT computer sessions over 10 weeks. The goal is to see if these therapies can reduce irritability and improve daily functioning.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cognitive Behavioral Therapy (CBT) and Interpretation Bias Training (IBT)
- What this could lead to
- If successful, this could provide the first psychological treatments specifically designed to help children with severe irritability and temper outbursts.
- What could go wrong
- This is an early-stage study with no prior results for these specific treatments in DMDD. The therapies may not reduce irritability more than no treatment, and results may not apply to all children.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2015
- Expected to finish
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May 2028
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
All outpatients, ages 8-17, enrolled in NIMH-DIRP Protocol 02-M-0021, and who are on stable, community treatment will be invited to participate in this study.
- Ages
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8 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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