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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00533806 |
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 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Family Based Treatment for Early Childhood OCD |
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.
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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.
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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.
Ages Eligible for Study: | 5 Years to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Molly Choate, PhD | 401-793-8284 | mchoate@lifespan.org |
Contact: Alexandra K. Ogata, AB | 401-444-3003 | aogata@lifespan.org |
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 |
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 |
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 |
Cognitive Behavior Therapy Active Control Relaxation Therapy Young Children |
Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder |
Pathologic Processes Disease |