A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
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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 |
- 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)
- 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 |
Inclusion Criteria:
- CY-BOCS Total Score ≥ 16;
- no change in psychotropic medication (if applicable) for at least 8 weeks prior to study entry;
- 7 to 17 years old; and
- availability of at least one parent to accompany the child to all treatment sessions.
Exclusion Criteria:
- 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;
- principal diagnosis other than OCD;
- 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| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| 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 Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013