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Psychological Treatments for Youth With Severe Irritability.

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ClinicalTrials.gov Identifier: NCT02531893
Recruitment Status : Recruiting
First Posted : August 25, 2015
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )

Tracking Information
First Submitted Date August 22, 2015
First Posted Date August 25, 2015
Last Update Posted Date June 3, 2019
Actual Study Start Date November 17, 2015
Estimated Primary Completion Date December 20, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2015)
  • Clinical Global Impression--Improvement score [ Time Frame: Day 11 ]
  • Affective Reactivity Index (ARI) [ Time Frame: Day 11 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02531893 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 22, 2015)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Psychological Treatments for Youth With Severe Irritability.
Official Title Psychological Treatments for Youth With Severe Irritability.
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.

Detailed Description

OBJECTIVE:

This purpose of this protocol is to further the development of two potential non-pharmacologic treatments for youths with chronic, severe and impairing irritability. The first potential treatment is Interpretation Bias Training (IBT), a computer-based training designed to shift emotional judgments of ambiguous faces away from angry, and toward happy, judgments. The first component of this protocol includes a randomized, controlled trial of active IBT in youth with severe irritability. The second potential treatment is a cognitive behavioral therapy (CBT) targeting severe irritability. The goal of this protocol is to conduct a preliminary study using a randomized within-subjects multiple-baseline design to test the efficacy of a new manualized exposure-based CBT with parenting training in the treatment of severe irritability.

Objective 1: Assess the efficacy of Interpretation Bias Training (IBT) in youths with severe irritability, operationalized as those meeting criteria for DSM-5 Disruptive Mood Dysregulation Disorder (DMDD). To accomplish this objective, we will conduct a randomized, controlled trial (RCT) of active IBT in 40 youths with DMDD. Subjects will be randomized to receive four IBT training sessions (active vs. placebo, in a double-blind design) over four days followed by weekly mood ratings for two weeks. Primary outcome measures in this trial will assess changes in irritability using the Affective Reactivity Index (ARI: clinician-rated, parent-rated, and child-rated) and Clinical Global Impressions-Improvement (CGI-I). After completing the RCT, all participants will be offered four open, active IBT sessions, delivered on the same schedule as in the RCT and using the same primary outcome measures.

Objective 2: Test the efficacy of a new manualized CBT for severe, impairing irritability in youth. To accomplish this objective, we will utilize a within-subjects multiple baseline design (Onghena & Edgington, 2005; Gliner, Morgan, Harmon, & Harmon, 2000; Morgan & Morgan, 2001). The children will be randomized to their start times. Clinical ratings, as well as parent- and child- report ratings will be obtained every two weeks (plus or minus two days) during both the baseline and active periods. This is not an RCT. All children will receive active CBT following variable (randomized) start times. Consistent with the manual we will continue to meet with children and their parents utilizing newly manualized exposure-based CBT procedures, such as eliciting hierarchies of irritability inducing events, exposure exercises (e.g., in-vivo, role-play, imaginal) and parent training. We will conduct the CBT on N=40 youth with severe, impairing irritability. Primary outcome measures for CBT will assess changes in irritability using the ARI (clinician-rated, parent-rated, and child-rated) and CGI-I.

Secondary Objective 1a and 1b: Assess the effect of IBT on clinical measures of depression, anxiety, and functional impairment.

Secondary Objective 2: Assess the effect of the CBT for irritability on clinical measures of depression, anxiety, and functional impairment.

Subjects can participate in one or both of these potential treatments. If they opt to do both, there will be a four-week wash-out period between treatments.

STUDY POPULATION:

The study is taking place at the National Institutes of Health (NIH). All outpatients, ages 8-17, enrolled in NIMH-DIRP Protocol 02-M-0021, who are in stable treatment in the community will be invited to participate in this study.

DESIGN:

The first part of the protocol will involve conducting a randomized controlled trial of IBT in 40 youths who meet criteria for DMDD. The goal of this novel, potential treatment is to decrease the severity of the child s irritability.

The second part of the protocol will involve conducting a randomized within-subjects multiple-baseline trial of CBT targeting severe irritability including N=40 youth.

Subjects can elect to participate in the IBT randomized controlled trial only, CBT treatment or both. If subjects elect to participate in both IBT and CBT, there will be a one-month wash-out period in between.

OUTCOME MEASURES:

The main outcome measures will assess changes in irritability using the ARI (clinician-rated, parent-rated, and child-rated, original and revised versions for IBT and CBT, respectively) and CGI-I. Secondary measures include parent and self-report measures of depression, anxiety, anger, social status, and aggression, as well as clinician ratings of depression, anxiety, and impairment. Data for ecological momentary assessments (EMA) will be collected using secure technology, with procedures approved by the NIMH ISSO; subjects and their caregivers will be asked a set of questions relating to recent experiences and emotions

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • DMDD (Disruptive Mood Dysregulation Disorder)
  • ADHD (Attention Deficit Hyperactivity Disorder)
  • ODD (Oppositional Defiant Disorder)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2015)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 30, 2022
Estimated Primary Completion Date December 20, 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Melissa A Brotman, Ph.D. (301) 435-6645 brotmanm@mail.nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02531893
Other Study ID Numbers 150182
15-M-0182
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Mental Health (NIMH) )
Study Sponsor National Institute of Mental Health (NIMH)
Collaborators Not Provided
Investigators
Principal Investigator: Melissa A Brotman, Ph.D. National Institute of Mental Health (NIMH)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date May 29, 2019