Family Based Treatment of Early Childhood Obsessive Compu... | NCT00055068

Studies
Family Based Treatment of Early Childhood Obsessive Compulsive Disorder

NCT00055068

Sponsor

Rhode Island Hospital

Status

Completed

Last Update Posted

May 7, 2014Estimated

Enrollment

38Estimated

Phase

Phase 3

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy (CBT)
Relaxation Training

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R21MH060669	U.S. NIH Grant/Contract		View source
DSIR CT-S

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2002

Primary Completion Date

Not provided

Completion Date

Feb 2006

First Submitted Date

Feb 19, 2003

First Submission Date that Met QC Criteria

Feb 19, 2003

First Posted Date

Feb 20, 2003Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2014

Last Update Posted Date

May 7, 2014Estimated

Name	Class
National Institute of Mental Health (NIMH)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obsessive Compulsive Disorder (OCD)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

8 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rhode Island Hospital/Brown University		Providence	Rhode Island	02903	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18356758	Derived	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.

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D015928	Cognitive Behavioral Therapy
D012064	Relaxation Therapy

ID	Term
D001521	Behavior Therapy
D011613	Psychotherapy
D004191	Behavioral Disciplines and Activities
D026441	Mind-Body Therapies

Name	Type	Description	Arm Group Labels	Other Names
Cognitive Behavioral Therapy (CBT)	Behavioral
Relaxation Training	Behavioral