NCT00690729

Brief Summary

This 16-week program examines cognitive behavioral bibliotherapy to typical therapist-directed cognitive behavior therapy for children and adolescents with Obsessive Compulsive Disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

August 30, 2010

Status Verified

August 1, 2010

Enrollment Period

4.7 years

First QC Date

June 3, 2008

Last Update Submit

August 26, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Child Yale-Brown Obsessive Compulsive Scale

    12 weeks

Secondary Outcomes (7)

  • NIMH Clinician's Global Impression

    weeks 4, 8, 12, 16

  • Children's Obsessional Compulsive Inventory

    weeks 4, 8, 12, and 16

  • Child OCD Impact Scale

    weeks 4, 8, 12, 16

  • March Anxiety Scale for Children

    weeks 4, 8, 12, 16

  • Children's Depression Inventory

    weeks 4, 8, 12, 16

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Bibliotherapy - cognitive behavior therapy focusing on exposure and response prevention directed by the family

Behavioral: Cognitive Behavioral Bibliotherapy

2

ACTIVE COMPARATOR

Cognitive Behavioral Therapy - therapist-directed exposure response prevention over a 12-week period

Behavioral: Cognitive Behavioral Therapy

Interventions

Minimal therapist direction for self-guided bibliotherapy involving exposure and response prevention

1

Therapist-directed exposure and response prevention

2

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 8-18 years old
  • Primary diagnosis of Obsessive Compulsive Disorder
  • Both parent and child fluent in English
  • Parents must read at least a 7th grade reading level

You may not qualify if:

  • Primary psychiatric diagnosis other than OCD
  • Current threat of harm to self or others
  • New use or dosage change of OCD medication 60 days prior to starting program
  • Current involvement with another psychosocial therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institute of Living

Hartford, Connecticut, 06106, United States

Location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Connecticut

Waterbury, Connecticut, 06702, United States

Location

University of Connecticut

West Hartford, Connecticut, 06117, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kimberli Treadwell, Ph.D.

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 3, 2008

First Posted

June 5, 2008

Study Start

July 1, 2005

Primary Completion

March 1, 2010

Study Completion

August 1, 2010

Last Updated

August 30, 2010

Record last verified: 2010-08

Locations