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NCT02531893 · ClinicalTrials.gov registry record
Psychological Treatments for Youth With Severe Irritability.
A clinical trial of Irritability, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT02531893: Recruiting study of Irritability, sponsored by National Institute of Mental Health (NIMH).
NCT02531893 is a study of Irritability that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 200 participants, above the 94-participant average among 3 other Irritability trials with a reported enrollment target (113% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02531893, a study of Irritability, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Clinician administered measure to assess clinical symptoms
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2015-11-17 |
| Est. Completion | 2028-05-08 |
What NCT02531893 shows while recruiting
NCT02531893 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 94-participant average among 3 other Irritability trials with a reported enrollment target (113% higher).
The record links to 1 condition, with Irritability appearing as the primary indexed condition, and to 0 interventions.
NCT02531893 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02531893 about?
NCT02531893 is a clinical study titled "Psychological Treatments for Youth With Severe Irritability.". 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...
What is the current status of trial NCT02531893?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2015-11-17. Estimated completion is 2028-05-08.
What conditions does trial NCT02531893 study?
This clinical trial studies the following conditions: Irritability.
Who is sponsoring clinical trial NCT02531893?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02531893 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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