Prader-Willi Syndrome Clinical Trials

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Adapting a Group Intervention for Emotion Dysregulation in Prader-Willi Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this study is to help teens with Prader-Willi Syndrome (PWS) and their families learn practical strategies for managing issues like irritability, meltdowns, and anxiety. The main objective of the study is: To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in Prader-Willi Syndrome (PWS) that will improve psychosocial outcomes for youth with PWS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 17
Healthy Volunteers: f
View:

• Ages 13-17.5 years

• Confirmed genetic diagnosis of Prader-Willi Syndrome

• Fluent in spoken English

• Adolescent's use of flexible phrase speech or greater

• Meeting clinically significant emotional dysregulation criteria

• Willing to participate in weekly 90-minute group sessions

• Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable

• Parent, guardian, or legally authorized representative must provide written permission on behalf of the participant

• Age ≥ 18 years

• Lives and cares for their child with PWS for \> 50% of the year

• Fluent in spoken English

• Willing to participate in twice weekly 90-minute sessions, including one virtual session weekly

Locations
United States
Missouri
Children's Mercy
RECRUITING
Kansas City
Contact Information
Primary
Grayson Manley, RN
gmanley@cmh.edu
816-816-6967
Time Frame
Start Date: 2026-08
Estimated Completion Date: 2027-11
Participants
Target number of participants: 10
Treatments
Experimental: Teens with Prader-Willi Syndrome and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
Related Therapeutic Areas
Sponsors
Collaborators: Foundation for Prader-Willi Research
Leads: Children's Mercy Hospital Kansas City

This content was sourced from clinicaltrials.gov