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Behavior Therapy for Children and Adolescents With Obsessive-Compulsive Disorder (OCD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000386
First Posted: November 3, 1999
Last Update Posted: February 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Mental Health (NIMH)
  Purpose

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.


Condition Intervention Phase
Obsessive-Compulsive Disorder Behavioral: Exposure and Response Prevention Behavioral: Family Treatment Program Behavioral: Relaxation Training Behavioral: Behavior therapy Behavioral: Family Counseling Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Behavior Therapy for Childhood OCD

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Study Start Date: December 1998
Estimated Study Completion Date: November 2003
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must have:

Obsessive-compulsive disorder for which he/she has not received medication.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000386


Locations
United States, California
Univ. of California / Los Angeles / Neuropsychiatric Inst.
Los Angeles, California, United States, 90024-1759
Sponsors and Collaborators
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: John C. Piacentini, PhD
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00000386     History of Changes
Other Study ID Numbers: R01MH058459 ( U.S. NIH Grant/Contract )
DSIR CT-S
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: February 12, 2008
Last Verified: February 2008

Keywords provided by National Institute of Mental Health (NIMH):
Adolescence
Child
Comparative Study
Family
Female
Human
Male
Obsessive-Compulsive Disorder
Relaxation Techniques
Obsessive-Compulsive Disorder -- *therapy

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders