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

Primary Purpose

Obsessive-Compulsive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Bibliotherapy
Cognitive Behavioral Therapy
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obsessive-Compulsive Disorder

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Living
  • University of Connecticut
  • University of Connecticut
  • University of Connecticut

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family

Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period

Outcomes

Primary Outcome Measures

Child Yale-Brown Obsessive Compulsive Scale

Secondary Outcome Measures

NIMH Clinician's Global Impression
Children's Obsessional Compulsive Inventory
Child OCD Impact Scale
March Anxiety Scale for Children
Children's Depression Inventory
Child Behavior Checklist
Family Assessment Measure III

Full Information

First Posted
June 3, 2008
Last Updated
August 26, 2010
Sponsor
UConn Health
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1. Study Identification

Unique Protocol Identification Number
NCT00690729
Brief Title
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Official Title
Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UConn Health

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family
Arm Title
2
Arm Type
Active Comparator
Arm Description
Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Bibliotherapy
Intervention Description
Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
Therapist-directed exposure and response prevention
Primary Outcome Measure Information:
Title
Child Yale-Brown Obsessive Compulsive Scale
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
NIMH Clinician's Global Impression
Time Frame
weeks 4, 8, 12, 16
Title
Children's Obsessional Compulsive Inventory
Time Frame
weeks 4, 8, 12, and 16
Title
Child OCD Impact Scale
Time Frame
weeks 4, 8, 12, 16
Title
March Anxiety Scale for Children
Time Frame
weeks 4, 8, 12, 16
Title
Children's Depression Inventory
Time Frame
weeks 4, 8, 12, 16
Title
Child Behavior Checklist
Time Frame
weeks 4, 8, 12, 16
Title
Family Assessment Measure III
Time Frame
weeks 4, 8, 12, 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberli Treadwell, Ph.D.
Organizational Affiliation
University of Connecticut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
University of Connecticut
City
Storrs
State/Province
Connecticut
ZIP/Postal Code
06269
Country
United States
Facility Name
University of Connecticut
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06702
Country
United States
Facility Name
University of Connecticut
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06117
Country
United States

12. IPD Sharing Statement

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

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