Obsessive-compulsive Disorder Clinical Trial
Official title:
Behavioral Treatment of Obsessive-Compulsive Symptoms in Youth With Prader-Willi Syndrome: A Pilot Project
Verified date | July 2011 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 17 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | All Children's Hospital | St. Petersburg | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | All Children’s Hospital Johns Hopkins Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997). | Baseline, Mid-Treatment, Post-treatment | No | |
Secondary | Clinical Global Improvement (CGI; Guy, 1976). | Mid- and Post-treatment | No |
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