A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

This study has been completed.
Sponsor:
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00369642
First received: August 24, 2006
Last updated: August 5, 2010
Last verified: April 2008
  Purpose

Pediatric obsessive-compulsive disorder (OCD) is a chronic and often disabling illness with an estimated lifetime prevalence of 1 to 3%. Pediatric OCD is associated with significant social, educational, and familial impairment, as well as comorbid emotional and behavioral disturbances that serve to complicate the prognosis of the illness and treatment outcome. While limited open treatment trials and one controlled trial have demonstrated cognitive-behavioral therapy (CBT) to be effective for pediatric OCD, controlled trials are lacking in the literature. There are a number of incremental benefits that an intensive program for OCD may offer. First, existing outpatient interventions typically achieve treatment gains over a 15 to 20 week period. The present program typically lasts between 2 to 4 weeks, and thus may present as a more timely, cost-effective, and efficient means of treatment for some individuals. Second, given that many children and adolescents may not have access to mental health professionals who are trained in empirically grounded interventions for OCD, the present treatment setting allows youth to receive appropriate, state of the art care. Finally, evidence suggests that daily CBT may be particularly effective in treating children who have been refractory to prior treatments (e.g., medication or once per week CBT). Prior to treatment, all consenting families will be randomly assigned to either the treatment condition or a three-week wait-list control condition. Those families randomized to the wait-list condition will receive treatment immediately after the three weeks are completed. The treatment group will be administered all measures immediately before treatment, immediately after treatment, and three months after treatment. The wait-list control condition will be administered all measures upon starting the wait-list period, immediately following the conclusion of the three-week wait-list period, and after the treatment program has finished. The purpose of the current study is to evaluate the efficacy of daily cognitive-behavioral treatment for pediatric OCD.


Condition Intervention Phase
Obsessive-Compulsive Disorder
Behavioral: Cognitive-behavioral therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS; Scahill et al., 1997)
  • Clinical Global Impression - Severity (CGI-S; National Institute of Mental Health, 1985)
  • Clinical Global Improvement (CGI; Guy, 1976)

Secondary Outcome Measures:
  • Multidemisional Anxiety Scale for Children
  • Children's Depression Inventory
  • Family Accommodation Scale

Estimated Enrollment: 60
Study Start Date: October 2004
Estimated Study Completion Date: December 2006
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. CY-BOCS Total Score ≥ 16;
  2. no change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry;
  3. 7 to 17 years old; and
  4. availability of at least one parent to accompany the child to all treatment sessions.

Exclusion Criteria:

  1. history of and/or current psychosis, pervasive developmental disorder, bipolar disorder, or current suicidality measured by the ADIS-IV-P and all available clinical information;
  2. principal diagnosis other than OCD;
  3. a positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric disorders or conditions that would limit their ability to understand CBT (based on clinical interview). Participants were not excluded due to comorbid psychiatric diagnoses.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369642

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of South Florida
Investigators
Principal Investigator: Eric Storch, PhD University of Florida
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00369642     History of Changes
Other Study ID Numbers: UF212-2004
Study First Received: August 24, 2006
Last Updated: August 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Cognitive-behavioral therapy
Children
Obsessive-compulsive disorder
Intensive Cognitive-behavioral therapy
Weekly Cognitive-behavioral therapy

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

ClinicalTrials.gov processed this record on August 21, 2014