Adapting DBT for Children With DMDD: Pilot RCT (NCT01862549) | Clinical Trial Compass
CompletedNot Applicable
Adapting DBT for Children With DMDD: Pilot RCT
United States43 participantsStarted 2013-05
Plain-language summary
This study examines feasibility and preliminary efficacy of Dialectical Behavior Therapy adapted to children (DBT-C). DBT-C as compared to treatment-as-usual (TAU) is hypothesized to have lower drop-out rate, and higher treatment attendance and satisfaction. Further, DBT-C as compared to TAU will have significantly greater reduction in symptoms of Disruptive Mood Dysregulation disorder, including verbal and behavioral outbursts and angry/irritable mood.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Ages 7 years 0 months to 12 years 11 months
. Meet criteria for Disruptive Mood Dysregulation Disorder on DSM-IV
. Stabilized on psychiatric medication (at least 6 weeks).
. Able to be treated on the outpatient basis
Exclusion criteria
. Documented cognitive disability ( if records are not available will use \< 85 IQ on Wechsler Intelligence Scale for Children-IV Information and Block Design subtests).
. Current diagnosis of a psychotic disorder (on K-SADS-PL)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Attendance and drop-out rate measure
Timeframe: 32 weeks
2
Therapy Satisfaction Questionnaire
Timeframe: 32 weeks
3
Therapist Satisfaction Questionaire
Timeframe: 32 weeks
4
Psychosocial Treatment Compliance Scale
Timeframe: 32 weeks
Trial details
NCT IDNCT01862549
SponsorWeill Medical College of Cornell University