Family Based Treatment of Early Childhood Obsessive Compulsive Disorder

Sponsor
Rhode Island Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00055068
Collaborator
National Institute of Mental Health (NIMH) (NIH)
38
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47.1
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Study Details

Study Description

Brief Summary

This study will evaluate a treatment program for young children with Obsessive Compulsive Disorder (OCD) and their families.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy (CBT)
  • Behavioral: Relaxation Training
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Family Based Treatment of Early Childhood OCD
Study Start Date :
Mar 1, 2002
Study Completion Date :
Feb 1, 2006

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Obsessive Compulsive Disorder (OCD)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rhode Island Hospital/Brown University Providence Rhode Island United States 02903

    Sponsors and Collaborators

    • Rhode Island Hospital
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00055068
    Other Study ID Numbers:
    • R21MH060669
    • R21MH060669
    • DSIR CT-S
    First Posted:
    Feb 20, 2003
    Last Update Posted:
    May 7, 2014
    Last Verified:
    Feb 1, 2008

    Study Results

    No Results Posted as of May 7, 2014