Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
| Status: | Archived |
|---|---|
| Conditions: | Psychiatric, Women's Studies |
| Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | September 2008 |
| End Date: | December 2010 |
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.
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.
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