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Clinical Trials/NCT00690729
NCT00690729CompletedNot Applicable

Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents

UConn Health6 sites in 1 country22 target enrollmentStarted: July 1, 2005Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
22
Locations
6
Primary Endpoint
Child Yale-Brown Obsessive Compulsive Scale

Study Overview

Brief Summary

This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.

Detailed Description

This study is designed to compare self-directed bibliotherapy and therapist-directed cognitive behavioral therapy for children and adolescents with Obsessive Compulsive Disorder (OCD). Both treatments involve exposure and response prevention (EX/RP), in which the child confronts OCD fears and is asked to refrain from compulsive rituals (such as repetitive handwashing, counting, etc.). Participants are requested to complete an initial evaluation to determine diagnosis, and four follow-up evaluations to assess symptom severity and change due to treatment for a total of 16 weeks. Participant involvement to self-directed bibliotherapy versus traditional cognitive-behavioral treatment will be determined through random assignment.

In the bibliotherapy condition, the child or adolescent will meet with a therapist twice over the course of treatment, along with a parent. The therapist will discuss a self-directed program of EX/RP to be implemented at a pace deemed appropriate by child and parent at their own home. The child and parent will be provided with a manual designed to instruct them how to cope with Obsessive Compulsive Disorder. This treatment involves the parent and child reading the book, performing exercises, and monitoring symptoms on a weekly basis for 8 weeks.

In the therapist-directed treatment condition, the child or adolescent will meet weekly with a therapist along with their parent. The therapist, parent, and child will work together to design and implement a program of EX/RP. This treatment involves performing exercises, monitoring symptoms on a weekly basis, and completing homework assignments. Parents will be asked to help coach their child with at-home exercises challenging the Obsessive Compulsive Disorder. This treatment lasts 12 weeks.

Evaluations will be conducted following the completion of each treatment to assess the efficacy of each treatment on OCD symptoms. The treatment and evaluations for OCD are provided free of charge.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
8 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Ages 8-18 years old
  • Primary diagnosis of Obsessive Compulsive Disorder
  • Both parent and child fluent in English
  • Parents must read at least a 7th grade reading level

Exclusion Criteria

  • Primary psychiatric diagnosis other than OCD
  • Current threat of harm to self or others
  • New use or dosage change of OCD medication 60 days prior to starting program
  • Current involvement with another psychosocial therapy

Outcomes

Primary Outcomes

Child Yale-Brown Obsessive Compulsive Scale

Time Frame: 12 weeks

Secondary Outcomes

  • NIMH Clinician's Global Impression(weeks 4, 8, 12, 16)
  • Children's Obsessional Compulsive Inventory(weeks 4, 8, 12, and 16)
  • Child OCD Impact Scale(weeks 4, 8, 12, 16)
  • March Anxiety Scale for Children(weeks 4, 8, 12, 16)
  • Children's Depression Inventory(weeks 4, 8, 12, 16)
  • Child Behavior Checklist(weeks 4, 8, 12, 16)
  • Family Assessment Measure III(weeks 4, 8, 12, 16)

Investigators

Sponsor
UConn Health
Sponsor Class
Other

Study Sites (6)

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