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| Descriptive Information Fields | |||||
| 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 | ||||
| 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 † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Child Yale-Brown Obsessive Compulsive Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | 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 ] |
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| Condition † | Obsessive-Compulsive Disorder | ||||
| Intervention † | Behavioral: Cognitive Behavioral Bibliotherapy Behavioral: Cognitive Behavioral Therapy |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 30 | ||||
| Start Date † | July 2005 | ||||
| Completion Date | July 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 8 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00690729 | ||||
| Organization ID | H06-170 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | University of Connecticut | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | University of Connecticut | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | June 3, 2008 | ||||
| Last Updated Date | June 3, 2008 | ||||
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