Recruiting
Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
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.
ClinicalTrials.gov IDNCT07607730
PhaseNA
Enrollment10
SponsorChildren's Mercy Hospital Kansas City
Age13 Years
SexALL
Conditions studied
Prader-Willi Syndrome
About this study
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.
Interventions
- Behavioral: Regulating 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.
Primary outcomes
- Emotion Dysregulation Inventory - Reactivity (From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed)
Eligibility information
Child Participant Inclusion Criteria:
* 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
Child Participant Exclusion Criteria:
* 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
Caregiver Inclusion Criteria:
* 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
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
Study locations
- Children's Mercy, Kansas City, Missouri 64108 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.