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| Tracking Information | |||||
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| First Received Date ICMJE | June 3, 2008 | ||||
| Last Updated Date | June 5, 2009 | ||||
| Start Date ICMJE | July 2005 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00690729 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cognitive-Behavioral Bibliotherapy for the Treatment of Obsessive Compulsive Disorder in Children and Adolescents | ||||
| Official Title ICMJE | Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents | ||||
| 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Obsessive-Compulsive Disorder | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | July 2009 | ||||
| Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00690729 | ||||
| Responsible Party | Kimberli Treadwell/Assistant Professor, University of Connecticut | ||||
| Study ID Numbers ICMJE | H06-170 | ||||
| Study Sponsor ICMJE | University of Connecticut | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Connecticut Health Center | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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