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NCT00055068 Clinical Trial

Family Based Treatment of Early Childhood Obsessive Compulsive Disorder

Obsessive-Compulsive Disorder Clinical Trial

Official title:
Family Based Treatment of Early Childhood OCD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00055068
Other study ID # R21MH060669
Secondary ID R21MH060669DSIR
Status Completed
Phase Phase 3
First received February 19, 2003
Last updated May 6, 2014
Start date March 2002
Est. completion date February 2006

Study information
Verified date February 2008
Source Rhode Island Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date February 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria:

- Obsessive Compulsive Disorder (OCD)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Cognitive Behavioral Therapy (CBT)

• Relaxation Training

Locations
Country Name City State
United States Rhode Island Hospital/Brown University Providence Rhode Island

Sponsors (2)
Lead Sponsor Collaborator
Rhode Island Hospital National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

See also
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Terminated NCT00758966 - Naltrexone SR and Fluoxetine Combination Therapy in Subjects With Obsessive-Compulsive Disorder Phase 2
Completed NCT00742664 - Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project Phase 1/Phase 2
Completed NCT00523718 - Riluzole Augmentation in Treatment-refractory Obsessive-compulsive Disorder Phase 2
Completed NCT00074815 - Treatment of Obsessive Compulsive Disorder in Children Phase 3

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