Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder

Obsessive Compulsive Disorder Clinical Trial

Official title:

Family Based Treatment for Early Childhood OCD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533806
• Other study ID #: R01MH079217
• Secondary ID: R01MH079217DSIR
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2007
• Last updated: March 7, 2013
• Start date: October 2007
• Est. completion date: January 2013

Study information

• Verified date: March 2013
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.

Description:

Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.

Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 8 Years

Eligibility

Inclusion Criteria:

• Meets DSM-IV criteria for OCD

• Parent willing to sign informed consent

Exclusion Criteria:

• History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation

• Psychotic symptoms

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive Compulsive Disorder
• Obsessive-Compulsive Disorder

Intervention

Behavioral:
• Cognitive Behavior Therapy
CBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management.
• Relaxation Therapy
Relaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing.

Locations

Country	Name	City	State
United States	Duke Child and Family Study Center	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Children's Yale-Brown Obsessive Compulsive Scale		Measured immediately post-treatment and at Months 3, 6, and 12	No
Secondary	Clinical Global Improvement		Measured immediately post-treatment and at Months 3, 6, and 12	No

External Links

•   Click here to learn more about The Pediatric Anxiety Research Clinic
•   Click here to visit the Obsessive Compulsive Foundation's Web site