Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project

This study has been completed.
Sponsor:
Collaborator:
All Children’s Hospital Johns Hopkins Medicine
Information provided by:
University of South Florida
ClinicalTrials.gov Identifier:
NCT00742664
First received: August 26, 2008
Last updated: August 4, 2011
Last verified: July 2011
  Purpose

Obsessive-compulsive (OC) symptoms are often present among youth with Prader-Willi Syndrome (PWS). They are also associated with considerable problems in the daily functioning of the child and his/her family. Although medication and behavioral treatments exist that target OC symptoms among youth without PWS, these treatments have not been thoroughly adapted for this population nor scientifically tested. Although medication has been helpful in addressing OC symptoms in several published case reports, the associated efficacy is modest and the potential for side effects is a realistic concern. Given that behavioral treatment for OC symptoms has superior efficacy to pharmacotherapy in youth without PWS without the accompanying risk for adverse side effects, it follows that an adapted version of behavioral therapy may hold promise in treating clinically problematic OC symptoms in youth with PWS. Thus, the purpose of the proposed grant is to develop and pilot-test a behavioral treatment for OC symptoms for use in youth with PWS. This study will allow us to develop and test a treatment protocol aimed at reducing OC symptoms that are clinically problematic and negatively impact functioning and quality of life in the child and his/her family.


Condition Intervention Phase
Prader Willi Syndrome
Obsessive-compulsive Disorder
Behavioral: Cognitive-behavioral therapy
Behavioral: Wait-list control
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997). [ Time Frame: Baseline, Mid-Treatment, Post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Improvement (CGI; Guy, 1976). [ Time Frame: Mid- and Post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: September 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Will receive 12 sessions of twice weekly psychotherapy targeting obsessive-compulsive symptoms.
Behavioral: Cognitive-behavioral therapy
The manual is informed by behavioral principles and provides a structured, replicable manner of treating OC symptoms in youth with PWS. The treatment is individual in nature, includes a strong family component (i.e., teaching parents to be their child's coach/therapist), and lasts for approximately 12 sessions, held in a twice-weekly format. In addition, the protocol includes several specific components: education about OC symptoms (i.e., etiology, behavioral function, etc.), developing a hierarchy of rituals to target, exposure and response prevention exercises, promoting adaptive familial responses to child behaviors, and relapse prevention and problem solving future situations.
Placebo Comparator: 2 Behavioral: Wait-list control
The subject will not receive active treatment during this interval.

Detailed Description:

Background: Obsessive-compulsive (OC) symptoms in youth with Prader-Willi Syndrome (PWS) are commonly present and associated with considerable functional impairment to the child and his/her family. Although pharmacological and behavioral treatments exist that target OC symptoms among youth without PWS, these treatments have not been systematically adapted for this population nor rigorously tested. Furthermore, although pharmacological interventions have shown promise in PWS in case reports, the efficacy is modest and the potential for side effects has been documented in youth with and without PWS. Given that behavioral treatment for OC symptoms has superior efficacy to pharmacotherapy in youth without PWS, without the accompanying risk for adverse side effects, it follows that an adapted version of this modality may hold promise in treating clinically problematic OC symptoms in youth with PWS.

Objectives: There are two primary study objectives: First, to develop a well-specified behaviorally oriented psychotherapy protocol that addresses OC symptoms, both food and non-food related, in youth with PWS. Second, to conduct a randomized wait-list controlled trial of the protocol in 12 youth with PWS.

Study Design: There will be two phases to this study: Phase I - Therapy development/manual writing and a small open trial; and Phase II - a small wait-list controlled pilot trial. Briefly, Phase I will concentrate on developing the treatment protocol through a process that draws on expert opinion coupled with focused interviews with parents. Based on this, a preliminary manual developed by the investigators will be piloted in 6 youth with PWS. Phase II will involve a preliminary test of the protocol in a sample of 12 families. This trial will focus primarily on feasibility issues (versus efficacy) in order to refine the manual, develop process measures to evaluate therapist's competence and adherence to manualized guidelines, train evaluators in assessment tasks, and develop data collection and coding systems. Six youth will be randomized to receive the treatment protocol, while 6 will participate in a wait-list of an equivalent time period. Diagnostic and symptom severity assessments will be conducted at appropriate time points (e.g., Screening, Baseline, Post-treatment) by a blinded, trained independent evaluator.

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The child must have a genetically confirmed diagnosis of PWS;
  2. CY-BOCS Compulsion Score ≥ 8. The Compulsion Scale Score is being used as youth with PWS may have difficulty understanding or identifying the connection between obsessional thoughts and subsequent rituals. Therefore, use of the Total Score may provide an inaccurate depiction of symptoms (Storch et al., 2005);
  3. Stable on any psychotropic medications for 8 weeks prior to study entry;
  4. Between the ages of 6 and 17 years as the present measures are valid for use in this age span;
  5. At least one parent available to accompany the child to all sessions; and
  6. English speaking.

Exclusion Criteria:

  1. Current suicidal intent or risk;
  2. A positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric conditions that would limit their ability to understand psychotherapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742664

Locations
United States, Florida
All Children's Hospital
St. Petersburg, Florida, United States, 33701
Sponsors and Collaborators
University of South Florida
All Children’s Hospital Johns Hopkins Medicine
Investigators
Principal Investigator: Eric Storch, Ph.D. University of South Florida
  More Information

No publications provided

Responsible Party: Eric Storch, Ph.D., Associate Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT00742664     History of Changes
Other Study ID Numbers: FPWR-CBT-001
Study First Received: August 26, 2008
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Prader-Willi Syndrome
Compulsive behavior
Hoarding
Obsessive-compulsive disorder
Children
Treatment
genetically
confirmed
diagnosis

Additional relevant MeSH terms:
Prader-Willi Syndrome
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Mental Retardation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn
Obesity
Overnutrition
Nutrition Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 22, 2014