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

NCT00742664 | Completed Phase 1

• 1 other identifier: FPWR-CBT-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prader Willi Syndrome; Obsessive-compulsive Disorder

Keywords

Prader-Willi Syndrome; Compulsive behavior; Hoarding; Obsessive-compulsive disorder; Children; Treatment; genetically; confirmed; diagnosis

Outcome Measures

Primary Outcomes (1)

• Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS; Scahill et al., 1997).

  Baseline, Mid-Treatment, Post-treatment

Secondary Outcomes (1)

• Clinical Global Improvement (CGI; Guy, 1976).

  Mid- and Post-treatment

Study Arms (2)

1

EXPERIMENTAL

Will receive 12 sessions of twice weekly psychotherapy targeting obsessive-compulsive symptoms.

Behavioral: Cognitive-behavioral therapy

2

PLACEBO COMPARATOR

Behavioral: Wait-list control

Interventions

Cognitive-behavioral therapy BEHAVIORAL

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.

1

Wait-list control BEHAVIORAL

The subject will not receive active treatment during this interval.

2

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child must have a genetically confirmed diagnosis of PWS;
• 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);
• Stable on any psychotropic medications for 8 weeks prior to study entry;
• Between the ages of 6 and 17 years as the present measures are valid for use in this age span;
• At least one parent available to accompany the child to all sessions; and
• English speaking.

You may not qualify if:

• Current suicidal intent or risk;
• A positive diagnosis in the caregiver of mental retardation, psychosis, or other psychiatric conditions that would limit their ability to understand psychotherapy.

Sponsors & Collaborators

• University of South Florida: lead
• Johns Hopkins All Children's Hospital: collaborator

Study Sites (1)

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

MeSH Terms

Conditions

Prader-Willi Syndrome; Obsessive-Compulsive Disorder; Compulsive Behavior; Hoarding; Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Anxiety Disorders; Mental Disorders; Impulsive Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Eric Storch, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 26, 2008
• First Posted: August 28, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: August 8, 2011

Record last verified: 2011-07

Locations

US (1)