Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder|
- Clinician Global Impression - Improvement Scale (Measure of patient improvement at relevent timepoints) [ Time Frame: Baseline/Post-treatment or Post-waitlist/1 and 3 Month Follow-up ] [ Designated as safety issue: No ]The CGI is a 7-point rating of treatment response anchored by 1 ("very much improved), 4 ("no change") and 7 ("very much worse"). Youth being rated by the IE as 1 ("very much improved") and 2 ("much improved") will be considered treatment responders. This measure assesses change or improvement across time and consequently is appropriate for use at multiple assessments - reflects patient improvement relative to baseline functioning. Represents change in functioning and assesses change in baseline. Appropriate for use at multiple time-points.
- CYBOCS - Childrens Yale Brown Obsessive Compulsive Scale [ Time Frame: Baseline, post-treatment/post waitlist, 1 and 3 month followup ] [ Designated as safety issue: No ]
The CY-BOCS is a 10-item semi-structured measure of obsession and compulsion severity over the previous week. Measure will be administered to the parent.
Change score (calculated as a percent change from baseline) will be used as the outcome measure.
|Study Start Date:||May 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
No Intervention: Treatment as Usual
Participants randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice.
Experimental: Immediate CBT
Therapists will work with families for 12 twice weekly sessions, each lasting up to 60 minutes implementing a developmentally appropriate modulated cognitive behavioral therapy approach. A manualized CBT protocol will be followed.
Behavioral: Cognitive Behavioral Therapy
Family based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits.
Other Name: ERP - Exposure response prevention
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447966
|United States, Florida|
|University of South Florida - Rothman Center for Neuropsychiatry|
|St. Petersburg, Florida, United States, 33701|
|Principal Investigator:||Adam B Lewin, Ph.D.||University of South Florida|