Family Based Treatment of Early Childhood Obsessive Compulsive Disorder - Tabular View

Tracking Information
First Received Date ^ICMJE	February 19, 2003
Last Updated Date	February 21, 2008
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00055068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Family Based Treatment of Early Childhood Obsessive Compulsive Disorder
Official Title ^ICMJE	Family Based Treatment of Early Childhood OCD
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.
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Condition ^ICMJE	Obsessive-Compulsive Disorder
Intervention ^ICMJE	Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Relaxation Training
Study Arms / Comparison Groups
Publications *	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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	38
Completion Date	February 2006
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Obsessive Compulsive Disorder (OCD)
Gender	Both
Ages	5 Years to 8 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00055068
Responsible Party
Study ID Numbers ^ICMJE	R21 MH60669, DSIR CT-S
Study Sponsor ^ICMJE	National Institute of Mental Health (NIMH)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Mental Health (NIMH)
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP