RecruitingNot ApplicableNCT07607730

Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation

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

Sponsor

Children's Mercy Hospital Kansas City

Enrollment

10 participants

Start Date

Aug 1, 2026

Study Type

INTERVENTIONAL

Conditions

Prader-Willi Syndrome

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

Min Age: 13 YearsMax Age: 17 Years

Inclusion Criteria12

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

Exclusion Criteria5

Initiation of new psychosocial intervention within 30 days prior to first day of treatment
Presence of physical aggression in the adolescent directed towards a peer outside the home that resulted in injury within 30 days prior to screening
Presence of comorbid major neuropsychiatric illness warranting other treatment approaches
Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BEHAVIORALRegulating Together group therapy

Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions. This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Prader-Willi Syndrome.