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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jennifer B. Freeman, Rhode Island Hospital
ClinicalTrials.gov Identifier:
NCT00533806
First received: September 19, 2007
Last updated: March 7, 2013
Last verified: March 2013

September 19, 2007
March 7, 2013
October 2007
October 2012   (final data collection date for primary outcome measure)
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 ]
Children's Yale-Brown Obsessive Compulsive Scale [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ]
Complete list of historical versions of study NCT00533806 on ClinicalTrials.gov Archive Site
Clinical Global Improvement [ Time Frame: Measured immediately post-treatment and at Months 3, 6, and 12 ] [ Designated as safety issue: No ]
Clinical Global Improvement [ Time Frame: Measured immediatley post-treatment and at Months 3, 6, and 12 ]
Not Provided
Not Provided
 
Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Obsessive Compulsive Disorder
  • 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.
  • 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.
  • Experimental: Cognitive behavioral therapy
    Participants will receive cognitive behavioral therapy.
    Intervention: Behavioral: Cognitive Behavior Therapy
  • Active Comparator: Relaxation therapy.
    Participants will receive relaxation therapy.
    Intervention: Behavioral: Relaxation Therapy
Freeman J, Sapyta J, Garcia A, Compton S, Khanna M, Flessner C, FitzGerald D, Mauro C, Dingfelder R, Benito K, Harrison J, Curry J, Foa E, March J, Moore P, Franklin M. Family-based treatment of early childhood obsessive-compulsive disorder: the Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children (POTS Jr)--a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):689-98. doi: 10.1001/jamapsychiatry.2014.170.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
127
January 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
5 Years to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533806
R01 MH079217, R01MH079217, DSIR 84-CTS
Yes
Jennifer B. Freeman, Rhode Island Hospital
Rhode Island Hospital
National Institute of Mental Health (NIMH)
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
Rhode Island Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP