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Trial NCT00000386

Resource URI: http://static.linkedct.org/resource/trials/NCT00000386
linkedct:brief_title Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)
linkedct:condition <http://static.linkedct.org/resource/condition/9124>
linkedct:criteria Inclusion Criteria: - Patients must have: Obsessive-compulsive disorder for which he/she has not received medication.
linkedct:description To evaluate a standardized multicomponent cognitive behavioral treatment program for child and adolescent obsessive-compulsive disorder (OCD). The treatment program consists of individual Exposure and Response Prevention (ERP) for the OCD child plus a concurrent family intervention designed to reduce OCD-related family conflict, facilitate family disengagement from the affected child's OCD behavior, and rebuild normal family interaction patterns. The ERP/Family Treatment Program is compared with Relaxation Training (RT). OCD is a chronic, often disabling disorder in childhood that has been associated with increased rates of parental psychopathology and significant disruptions in family relationships and functioning. Preliminary studies suggest that ERP is an effective treatment for children with OCD although no controlled trials to this effect have been published. RT was selected as the comparison treatment because of its credibility as an anxiety treatment and familiarity to potential subjects. RT has been used as a comparison condition for at least 2 randomized controlled ERP trials for adult OCD and shown to be ineffective in treating this disorder. Although it has long been hypothesized that family participation in treatment may be helpful, this is the first controlled study incorporating a systematic manualized family treatment component. Participants are randomly assigned to receive either the combined ERP/Family Treatment Program (n=56) or RT (n=24). Both treatments are delivered over 12 90-minute outpatient sessions according to detailed treatment manuals.Youth and families undergo comprehensive and systematic, including behavioral, assessments by blind clinical evaluators at baseline, monthly during treatment, post-treatment and 2 follow-up evaluations over 6 months. Treatment outcome is examined in multimodal fashion and across multiple functional domains with a special emphasis on family contextual variables. The impact of baseline functioning, including family context, and initial change over time on treatment outcome is also systematically evaluated.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 17 Years
linkedct:eligibility_minimum_age 8 Years
linkedct:end_date November 2003
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000386
rdfs:label Trial NCT00000386
linkedct:lastchanged_date February 8, 2008
linkedct:lead_sponsor_agency National Institute of Mental Health (NIMH)
linkedct:location <http://static.linkedct.org/resource/location/209835>
linkedct:nct_id NCT00000386
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Behavior Therapy for Childhood OCD
linkedct:org_study_id R01 MH58459
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/28660>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000386>
linkedct:phase Phase 3
linkedct:secondary_id DSIR CT-S
linkedct:source National Institute of Mental Health (NIMH)
linkedct:start_date December 1998
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary The purpose of this study is to evaluate a behavioral treatment program for children and adolescents with OCD and their families. Exposure and Response Prevention (ERP) behavior therapy, in which the patient is gradually exposed to the object or situation that causes anxiety and is taught to refrain from responding in a compulsive manner, is combined with family counseling (Family Treatment Program). This treatment will be compared to Relaxation Training (RT). OCD is a long-term, often disabling disorder that can cause significant family disruption. ERP is a promising treatment for children with OCD, and it is thought that family participation (through the Family Treatment Program) may be a helpful addition. RT is a common treatment for anxiety. Patients are assigned randomly (like tossing a coin) to receive either the ERP/Family Treatment Program or RT. Both treatments will be delivered over 12 90-minute outpatient sessions to youngsters and their families. All participants (patients and family members) will be assessed for treatment response each month during treatment, after treatment is finished, and then at 2 follow-up visits over the following 6 months. A child/adolescent may be eligible for this study if he/she: Has obsessive-compulsive disorder (OCD), is medication-free, and is 8 to 17 years old.
rdf:type linkedct:trials
linkedct:verification_date February 2008