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
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.
To test two whether IBT and CBT can decrease severe irritability in children and youth.
Children 8-17 years old with DMDD. Their symptoms must have started before age 10.
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|
|DMDD (Disruptive Mood Dysregulation Disorder) ADHD (Attention Deficit Hyperactivity Disorder) ODD (Oppositional Defiant Disorder)|
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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.
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.
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.
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|
|Estimated Enrollment :||200 participants|
|Official Title:||Psychological Treatments for Youth With Severe Irritability.|
|Actual Study Start Date :||November 17, 2015|
|Estimated Primary Completion Date :||December 20, 2022|
|Estimated Study Completion Date :||December 30, 2022|
- Clinical Global Impression--Improvement score [ Time Frame: Day 11 ]
- Affective Reactivity Index (ARI) [ Time Frame: Day 11 ]
- 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 ]
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
|Contact: Melissa A Brotman, Ph.D.||(301) email@example.com|
|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 Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Melissa A Brotman, Ph.D.||National Institute of Mental Health (NIMH)|