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

March 7, 2013 updated by: Jennifer B. Freeman, Rhode Island Hospital

Family Based Treatment for Early Childhood OCD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

127

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Child and Family Study Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognitive behavioral therapy
Participants will receive cognitive behavioral therapy.
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.
Active Comparator: Relaxation therapy.
Participants will receive relaxation therapy.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Children's Yale-Brown Obsessive Compulsive Scale
Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12
Measured immediately post-treatment and at Months 3, 6, and 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Improvement
Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12
Measured immediately post-treatment and at Months 3, 6, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhode Island Hospital

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Jennifer B. Freeman, PhD, Rhode Island Hospital/ Brown Medical School
  • Principal Investigator: Marty Franklin, PhD, University of Pennsylvania
  • Principal Investigator: John S. March, MD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 21, 2007

Study Record Updates

Last Update Posted (Estimate)

March 11, 2013

Last Update Submitted That Met QC Criteria

March 7, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH079217 (U.S. NIH Grant/Contract)
  • DSIR 84-CTS (Division of Services and Intervention Research)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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