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Psychological Treatments for Youth With Severe Irritability.

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 23, 2017 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
ClinicalTrials.gov Identifier:
NCT02531893
First received: August 22, 2015
Last updated: April 21, 2017
Last verified: March 23, 2017
  Purpose

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.


Condition
DMDD (Disruptive Mood Dysregulation Disorder)
ADHD (Attention Deficit Hyperactivity Disorder)
ODD (Oppositional Defiant Disorder)

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Psychological Treatments for Youth With Severe Irritability.

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Clinical Global Impression--Improvement score [ Time Frame: Day 11 ]
  • Affective Reactivity Index (ARI) [ Time Frame: Day 11 ]

Secondary Outcome Measures:
  • parent and self-report measures of depression, anxiety, anger, social status, and aggression, as well as clinician ratings of depression, anxiety, and impairment [ Time Frame: Day 11 ]

Estimated Enrollment: 200
Study Start Date: August 13, 2015
Estimated Study Completion Date: December 30, 2022
Estimated Primary Completion Date: August 1, 2019 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    1. Must meet all of the following:

      • Diagnosis must first be made between ages 6-18 years
      • 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).
      • 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.
    2. 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.
    3. The onset of symptoms must be prior to age 10 years.
    4. 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. (A) For Interpretation Bias Training (IBT) RCT:

    1. 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).
    2. 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.

5. (B) For Cognitive Behavior Therapy (CBT):

  1. 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).
  2. Patients can be medication-free, on psychotropic medication, and/or in psychotherapeutic treatment.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02531893

Contacts
Contact: Melissa A Brotman, Ph.D. (301) 435-6645 brotmanm@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Melissa A Brotman, Ph.D. National Institute of Mental Health (NIMH)
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02531893     History of Changes
Other Study ID Numbers: 150182
15-M-0182
Study First Received: August 22, 2015
Last Updated: April 21, 2017

Keywords provided by National Institutes of Health Clinical Center (CC):
Irritability
Disruptive Mood
Tantrums
Frustration
Interpretation Bias
Emotional Judgment
Cognitive-Behavioral
Exposure
Research Psychotherapy

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 24, 2017