Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exposure and Response Prevention
Family Treatment Program
Relaxation Training
Behavior therapy
Family Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder focused on measuring Adolescence, Child, Comparative Study, Family, Female, Human, Male, Obsessive-Compulsive Disorder, Relaxation Techniques, Obsessive-Compulsive Disorder -- *therapy
Eligibility Criteria
Inclusion Criteria: - Patients must have: Obsessive-compulsive disorder for which he/she has not received medication.
Sites / Locations
- Univ. of California / Los Angeles / Neuropsychiatric Inst.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000386
First Posted
November 2, 1999
Last Updated
February 8, 2008
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00000386
Brief Title
Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)
Official Title
Behavior Therapy for Childhood OCD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
Keywords
Adolescence, Child, Comparative Study, Family, Female, Human, Male, Obsessive-Compulsive Disorder, Relaxation Techniques, Obsessive-Compulsive Disorder -- *therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Exposure and Response Prevention
Intervention Type
Behavioral
Intervention Name(s)
Family Treatment Program
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Type
Behavioral
Intervention Name(s)
Behavior therapy
Intervention Type
Behavioral
Intervention Name(s)
Family Counseling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-
Patients must have:
Obsessive-compulsive disorder for which he/she has not received medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C. Piacentini, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univ. of California / Los Angeles / Neuropsychiatric Inst.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024-1759
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23774008
Citation
Kircanski K, Wu M, Piacentini J. Reduction of subjective distress in CBT for childhood OCD: nature of change, predictors, and relation to treatment outcome. J Anxiety Disord. 2014 Mar;28(2):125-32. doi: 10.1016/j.janxdis.2013.05.004. Epub 2013 May 21.
Results Reference
derived
PubMed Identifier
22024003
Citation
Piacentini J, Bergman RL, Chang S, Langley A, Peris T, Wood JJ, McCracken J. Controlled comparison of family cognitive behavioral therapy and psychoeducation/relaxation training for child obsessive-compulsive disorder. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1149-61. doi: 10.1016/j.jaac.2011.08.003. Epub 2011 Sep 22.
Results Reference
derived
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Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)
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