Clinical trial NCT00690729: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Lead sponsor: UConn Health
Sponsor class: OTHER
First posted: 2008-06-05
Enrollment: 22
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Yale-Brown Obsessive Compulsive Scale
timeFrame: 12 weeks
Secondary outcomes:
measure: NIMH Clinician's Global Impression
timeFrame: weeks 4, 8, 12, 16
measure: Children's Obsessional Compulsive Inventory
timeFrame: weeks 4, 8, 12, and 16
measure: Child OCD Impact Scale
timeFrame: weeks 4, 8, 12, 16
measure: March Anxiety Scale for Children
timeFrame: weeks 4, 8, 12, 16
measure: Children's Depression Inventory
timeFrame: weeks 4, 8, 12, 16
measure: Child Behavior Checklist
timeFrame: weeks 4, 8, 12, 16
measure: Family Assessment Measure III
timeFrame: weeks 4, 8, 12, 16
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Institute of Living
state: Connecticut
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Waterbury
country: United States
facility: University of Connecticut
state: Connecticut
city: West Hartford
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
affiliation: University of Connecticut
name: Kimberli Treadwell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: