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

This study has been completed.
Sponsor:
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00690729
First received: June 3, 2008
Last updated: August 26, 2010
Last verified: August 2010

June 3, 2008
August 26, 2010
July 2005
March 2010   (final data collection date for primary outcome measure)
Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00690729 on ClinicalTrials.gov Archive Site
  • NIMH Clinician's Global Impression [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Children's Obsessional Compulsive Inventory [ Time Frame: weeks 4, 8, 12, and 16 ] [ Designated as safety issue: No ]
  • Child OCD Impact Scale [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • March Anxiety Scale for Children [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Children's Depression Inventory [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Child Behavior Checklist [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
  • Family Assessment Measure III [ Time Frame: weeks 4, 8, 12, 16 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents
Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive-Compulsive Disorder
  • Behavioral: Cognitive Behavioral Bibliotherapy
    Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention
  • Behavioral: Cognitive Behavioral Therapy
    Therapist-directed exposure and response prevention
  • Experimental: 1
    Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family
    Intervention: Behavioral: Cognitive Behavioral Bibliotherapy
  • Active Comparator: 2
    Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period
    Intervention: Behavioral: Cognitive Behavioral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
August 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00690729
H06-170
No
Kimberli Treadwell/Assistant Professor, University of Connecticut
University of Connecticut Health Center
Not Provided
Principal Investigator: Kimberli Treadwell, Ph.D. University of Connecticut
University of Connecticut Health Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP