Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
Primary Purpose
Obsessive Compulsive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavior Therapy
Relaxation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive Compulsive Disorder focused on measuring Cognitive Behavior Therapy, Active Control, Relaxation Therapy, Young Children
Eligibility 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
Sites / Locations
- Duke Child and Family Study Center
- University of Pennsylvania
- Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive behavioral therapy
Relaxation therapy.
Arm Description
Participants will receive cognitive behavioral therapy.
Participants will receive relaxation therapy.
Outcomes
Primary Outcome Measures
Children's Yale-Brown Obsessive Compulsive Scale
Secondary Outcome Measures
Clinical Global Improvement
Full Information
NCT ID
NCT00533806
First Posted
September 19, 2007
Last Updated
March 7, 2013
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00533806
Brief Title
Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
Official Title
Family Based Treatment for Early Childhood OCD
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive Compulsive Disorder
Keywords
Cognitive Behavior Therapy, Active Control, Relaxation Therapy, Young Children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavioral therapy
Arm Type
Experimental
Arm Description
Participants will receive cognitive behavioral therapy.
Arm Title
Relaxation therapy.
Arm Type
Active Comparator
Arm Description
Participants will receive relaxation therapy.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavior Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Children's Yale-Brown Obsessive Compulsive Scale
Time Frame
Measured immediately post-treatment and at Months 3, 6, and 12
Secondary Outcome Measure Information:
Title
Clinical Global Improvement
Time Frame
Measured immediately post-treatment and at Months 3, 6, and 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer B. Freeman, PhD
Organizational Affiliation
Rhode Island Hospital/ Brown Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marty Franklin, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John S. March, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Child and Family Study Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24759852
Citation
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.
Results Reference
derived
Links:
URL
http://www.anxiouskids.org
Description
Click here to learn more about The Pediatric Anxiety Research Clinic
URL
http://www.ocfoundation.org
Description
Click here to visit the Obsessive Compulsive Foundation's Web site
Learn more about this trial
Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
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