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New hope for chronically cranky kids: therapy trial targets severe temper outbursts

NCT ID NCT02531893

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2015

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

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

8 to 17 years

Sex

Anyone

Healthy volunteers

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

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

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How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

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