Clinical trial NCT00533806: Comparing the Effectiveness of Two Family-based Therapies in Treating Young Children With Obsessive-Compulsive Disorder
Official title: Family Based Treatment for Early Childhood OCD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive Compulsive Disorder
Keywords: Cognitive Behavior Therapy
Active Control
Relaxation Therapy
Young Children
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2007-09-21
Enrollment: 127
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale
timeFrame: Measured immediately post-treatment and at Months 3, 6, and 12
Secondary outcomes:
measure: Clinical Global Improvement
timeFrame: Measured immediately post-treatment and at Months 3, 6, and 12
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Providence
country: United States
facility: Brown Medical School/ Rhode Island Hospital/ Pediatric Anxiety Research Clinic
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital/ Brown Medical School
name: Jennifer B. Freeman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Marty Franklin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: John S. March, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.