Psychological treatments for children with severe irritability

Psychological Treatments for Youth With Severe Irritability

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 type: Observational
• Enrollment: 200 (estimated)
• Ages: 8 Years to 17 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT02531893 on ClinicalTrials.gov

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.

Who should consider this trial

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

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.

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

Eligibility 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 this trial is running

Bethesda, Maryland

• 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.

Conditions Irritability; Interpretation Bias Training; Cognitive Behavioral Therapy; Children; Natural History