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

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

Detailed Description
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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.

Official Title
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Cognitive-Behavioral Treatment of Obsessive Compulsive Disorder in Children and Adolescents

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Bibliotherapy
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family | Behavioral: Cognitive Behavioral Bibliotherapy<br>* Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention<br>|
| Active Comparator: 2<br>Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period | Behavioral: Cognitive Behavioral Therapy<br>* Therapist-directed exposure and response prevention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Yale-Brown Obsessive Compulsive Scale |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIMH Clinician's Global Impression |  | weeks 4, 8, 12, 16 | 
| Children's Obsessional Compulsive Inventory |  | weeks 4, 8, 12, and 16 | 
| Child OCD Impact Scale |  | weeks 4, 8, 12, 16 | 
| March Anxiety Scale for Children |  | weeks 4, 8, 12, 16 | 
| Children's Depression Inventory |  | weeks 4, 8, 12, 16 | 
| Child Behavior Checklist |  | weeks 4, 8, 12, 16 | 
| Family Assessment Measure III |  | weeks 4, 8, 12, 16 |