NCT00533806

Brief Summary

This study will compare the effectiveness of family-based cognitive behavioral therapy to family-based relaxation therapy in treating young children with obsessive-compulsive disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3

Geographic Reach
1 country

3 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

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
10 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

5 years

First QC Date

September 19, 2007

Last Update Submit

March 7, 2013

Conditions

Obsessive Compulsive Disorder

Keywords

Cognitive Behavior TherapyActive ControlRelaxation TherapyYoung Children

Outcome Measures

Primary Outcomes (1)

  • Children's Yale-Brown Obsessive Compulsive Scale

    Measured immediately post-treatment and at Months 3, 6, and 12

Secondary Outcomes (1)

  • Clinical Global Improvement

    Measured immediately post-treatment and at Months 3, 6, and 12

Study Arms (2)

Cognitive behavioral therapy

EXPERIMENTAL

Participants will receive cognitive behavioral therapy.

Behavioral: Cognitive Behavior Therapy

Relaxation therapy.

ACTIVE COMPARATOR

Participants will receive relaxation therapy.

Behavioral: Relaxation Therapy

Interventions

Cognitive Behavior TherapyBEHAVIORAL

CBT includes 12 treatment sessions over 14 weeks. The sessions deliver family-based exposure with response prevention. Participants assigned to receive CBT will learn skills to help control OCD. CBT sessions will also include education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management.

Cognitive behavioral therapy
Relaxation TherapyBEHAVIORAL

Relaxation therapy includes 12 sessions delivered over 14 weeks. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing.

Relaxation therapy.

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Meets DSM-IV criteria for OCD
  • Parent willing to sign informed consent

You may not qualify if:

  • History or current diagnosis of pervasive developmental disorder(s), thought disorder, or mental retardation
  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Duke Child and Family Study Center

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Freeman J, Sapyta J, Garcia A, Compton S, Khanna M, Flessner C, FitzGerald D, Mauro C, Dingfelder R, Benito K, Harrison J, Curry J, Foa E, March J, Moore P, Franklin M. Family-based treatment of early childhood obsessive-compulsive disorder: the Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children (POTS Jr)--a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):689-98. doi: 10.1001/jamapsychiatry.2014.170.

    PMID: 24759852DERIVED

Related Links

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral TherapyRelaxation Therapy

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeutics

Study Officials

  • Jennifer B. Freeman, PhD

    Rhode Island Hospital/ Brown Medical School

    PRINCIPAL INVESTIGATOR

  • Marty Franklin, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • John S. March, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Outpatient Child Psychiatry; Staff Psychologist

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

October 1, 2007

Primary Completion

October 1, 2012

Study Completion

January 1, 2013

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

US(3)