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

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT07607730
Status
Recruiting

Conditions

  • Prader-Willi Syndrome

Eligibility Criteria

Sex
ALL
Age
13 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Regulating Together group therapy — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Teens with Prader-Willi Syndrome and their caregiver
    Participants will receive Regulating Together - the emotion dysregulation intervention

Primary Outcome Measure

Emotion Dysregulation Inventory - Reactivity [ Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's MercyKansas CityMissouri64108
Grayson Manley, RN
816-816-6967
Walker McKinney, PhD
816-234-3656
Walker McKinney, PhD (PRINCIPAL_INVESTIGATOR)

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