Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder

NCT ID: NCT00533806

Last Updated: 2013-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2013-01-31

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.

Detailed Description

Obsessive-compulsive disorder (OCD) is a type of anxiety disorder that affects approximately 1 in 200 children. Although feelings of anxiety, fear, and uncertainty are a normal part of life and growing up, for some children these feelings and emotions become chronic, relentless, and progressively worse if left untreated. OCD is characterized by obsessions, or repeated unsettling thoughts, causing a person to perform repeated actions called compulsions. Children are typically not diagnosed with OCD until they are between the ages of 8 and 12, leaving many young children undiagnosed. Additionally, no psychotherapy treatments have been designed for young children who are under the age of 8 and have OCD. The purpose of this study is to develop and evaluate a family-based treatment program for children, ages 5 to 8, who have been diagnosed with OCD.

Participants in this open-label study will be randomly assigned to receive either cognitive behavior therapy (CBT) or relaxation therapy for 12 sessions over a period of 14 weeks. All children will undergo a 3-hour screening that will include a psychiatric evaluation and the completion of questionnaires. Parents of participating children will attend the first two treatment sessions without their children during which they will be introduced to the treatment program and will learn various skills to be used throughout treatment. The other 10 1-hour sessions will be attended by both the parent and child. Participants assigned to receive CBT will learn skills to help control OCD. Education about OCD, family therapy, parent training to manage child behavior problems, and anxiety management will be included in the CBT sessions. Participants assigned to receive relaxation therapy will discuss general family functioning, issues related to OCD, and other behavioral problems the child may be experiencing. Treatment will also include education about OCD; affective education, during which participants will learn how to recognize feelings; muscle relaxation techniques; and guided imagery. Participants in both treatment groups will receive weekly homework assignments after each session to practice skills learned. Parents will also be asked to monitor their child's behavior and practice the learned skills with their child as often as possible. If treatment has not been successful after the 14-week period, the child will be offered an alternative treatment. All participants will be assessed before treatment; at 5, 9, and 14 weeks of treatment; and at 3, 6, and 12 months after treatment.

Conditions

Obsessive Compulsive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive behavioral therapy

Participants will receive cognitive behavioral therapy.

Group Type: EXPERIMENTAL

Cognitive Behavior Therapy

Intervention Type: BEHAVIORAL

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.

Relaxation therapy.

Participants will receive relaxation therapy.

Group Type: ACTIVE_COMPARATOR

Relaxation Therapy

Intervention Type: BEHAVIORAL

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.

Interventions

Cognitive Behavior Therapy

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.

Intervention Type: BEHAVIORAL

Relaxation Therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jennifer B. Freeman

Director, Outpatient Child Psychiatry; Staff Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer B. Freeman, PhD

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital/ Brown Medical School

Marty Franklin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

John S. March, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Child and Family Study Center

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

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

Providence, Rhode Island, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 24759852 (View on PubMed)

Related Links

http://www.ocfoundation.org

Click here to visit the Obsessive Compulsive Foundation's Web site

Other Identifiers

R01MH079217

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 84-CTS

Identifier Type: -

Identifier Source: secondary_id

R01MH079217

Identifier Type: NIH

Identifier Source: org_study_id

View Link