Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Primary Purpose
Obsessive-Compulsive Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy (CBT)
Relaxation Training
Sponsored by
About this trial
This is an interventional treatment trial for Obsessive-Compulsive Disorder
Eligibility Criteria
Inclusion Criteria: Obsessive Compulsive Disorder (OCD)
Sites / Locations
- Rhode Island Hospital/Brown University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00055068
First Posted
February 19, 2003
Last Updated
May 6, 2014
Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00055068
Brief Title
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Official Title
Family Based Treatment of Early Childhood OCD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rhode Island Hospital
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
5. Study Description
Brief Summary
This study will evaluate a treatment program for young children with Obsessive Compulsive Disorder (OCD) and their families.
Detailed Description
Childhood onset OCD is a serious condition that may be a predictor of illness in adulthood. To date, no OCD psychotherapy trials have specifically focused on early childhood. Development of interventions for childhood onset OCD that address both developmental considerations and familial relationships is necessary.
Participants are randomly assigned to receive 12 sessions of either Cognitive Behavioral Therapy (CBT) or Relaxation Training (RT) over the course of 14 weeks. The CBT treatment is designed to lessen anxiety by addressing specific OCD symptoms. The relaxation intervention addresses generalized feelings of anxiety with the expectation that OCD symptoms may benefit indirectly. The clarity, completeness, acceptability, and feasibility of both interventions is assessed. A 3-month post-treatment follow-up is also conducted.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obsessive-Compulsive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
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:
Obsessive Compulsive Disorder (OCD)
Facility Information:
Facility Name
Rhode Island Hospital/Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18356758
Citation
Freeman JB, Garcia AM, Coyne L, Ale C, Przeworski A, Himle M, Compton S, Leonard HL. Early childhood OCD: preliminary findings from a family-based cognitive-behavioral approach. J Am Acad Child Adolesc Psychiatry. 2008 May;47(5):593-602. doi: 10.1097/CHI.0b013e31816765f9.
Results Reference
derived
Links:
URL
http://www.anxiouskids.org
Description
Click here for more information about anxiety in children.
Learn more about this trial
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
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