Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
|ClinicalTrials.gov Identifier: NCT00533806|
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : March 11, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obsessive Compulsive Disorder||Behavioral: Cognitive Behavior Therapy Behavioral: Relaxation Therapy||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||127 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Family Based Treatment for Early Childhood OCD|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||January 2013|
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.
- Children's Yale-Brown Obsessive Compulsive Scale [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ]
- Clinical Global Improvement [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533806
|United States, North Carolina|
|Duke Child and Family Study Center|
|Durham, North Carolina, United States, 27705|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic|
|Providence, Rhode Island, United States, 02903|
|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|