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Psychological Treatments for Youth With Severe Irritability.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531893
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : May 26, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Study Description
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Brief Summary:

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 or disease
Irritability

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Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Psychological Treatments for Youth With Severe Irritability
Actual Study Start Date : November 17, 2015
Estimated Primary Completion Date : May 8, 2028
Estimated Study Completion Date : May 8, 2028
Groups and Cohorts
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Group/Cohort
Irritable youth
Participants meet full DMDD criteria for IBT and either full DMDD or one of two core DMDD criteria for CBT.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical Global Impression--Improvement score [ Time Frame: Every two weeks ]
    Clinician administered measure to assess clinical symptoms

  2. Affective Reactivity Index (ARI) [ Time Frame: Every two weeks ]
    Clinician administered measure to assess clinical symptoms


Secondary Outcome Measures :
  1. parent and self-report measures of irritability, depression, anxiety, anger, social status, and aggression, as well as clinician ratings of depression, anxiety, and impairment [ Time Frame: Weekly ]
    Self- and parent-report measures to assess clinical symptoms


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02531893


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

Locations
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United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY dial 711    ccopr@nih.gov   
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Melissa A Brotman, Ph.D. National Institute of Mental Health (NIMH)
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT02531893    
Other Study ID Numbers: 150182
15-M-0182
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: May 26, 2023
Last Verified: March 14, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .No individual participant data (IPD) will be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) ):
Interpretation Bias Training
Cognitive Behavioral Therapy
Children
Natural History