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Comparing the Effectiveness of Two Family-Based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), March 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00533806
  Purpose

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.


Condition Intervention Phase
Obsessive Compulsive Disorder
Behavioral: Cognitive Behavior Therapy
Behavioral: Relaxation Therapy
Phase III

MedlinePlus related topics: Anxiety Obsessive-Compulsive Disorder
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Family Based Treatment for Early Childhood OCD

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Children's Yale-Brown Obsessive Compulsive Scale [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Improvement [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 124
Study Start Date: October 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental 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.
B: Active Comparator 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.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533806

Contacts
Contact: Molly Choate, PhD 401-793-8284 mchoate@lifespan.org
Contact: Alexandra K. Ogata, AB 401-444-3003 aogata@lifespan.org

Locations
United States, North Carolina
Duke Child and Family Study Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Jeffrey Sapyta, PhD     919-416-2451     jeffrey.sapyta@duke.edu    
Principal Investigator: John S. March, MD            
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Martin Franklin, PhD     215-573-3708     marty@mail.med.upenn.edu    
Principal Investigator: Martin Franklin, PhD            
United States, Rhode Island
Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic Recruiting
Providence, Rhode Island, United States, 02903
Contact: Molly Choate, PhD     401-793-8284     mchoate@lifespan.org    
Contact: Alexandra K. Ogata, AB     401-444-3003     aogata@lifespan.org    
Principal Investigator: Jennifer B. Freeman, PhD            
Sponsors and Collaborators
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
  More Information

Click here to learn more about The Pediatric Anxiety Research Clinic  This link exits the ClinicalTrials.gov site
Click here to visit the Obsessive Compulsive Foundation's Web site  This link exits the ClinicalTrials.gov site

Responsible Party: Rhode Island Hospital ( Jennifer Freeman )
Study ID Numbers: R01 MH079217, DSIR 84-CTS
Study First Received: September 19, 2007
Last Updated: March 6, 2008
ClinicalTrials.gov Identifier: NCT00533806  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Cognitive Behavior Therapy
Active Control
Relaxation Therapy
Young Children

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Obsessive-Compulsive Disorder

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 30, 2009