Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation (RT-PWS)

May 26, 2026 updated by: Walker McKinney, Children's Mercy Hospital Kansas City

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Up to ten children with Prader-Willi Syndrome (PWS) ages 13 to 17.5 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help teenagers with PWS calm their emotions. Participants will complete assessments at five time points:

Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Grayson Manley, RN
  • Phone Number: 816-816-6967
  • Email: gmanley@cmh.edu

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Walker McKinney, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Teens with Prader-Willi Syndrome and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emotion Dysregulation Inventory - Reactivity
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
The Emotion Dysregulation Inventory consists of two subscales. We will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation. Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver and Adolescent Readiness and Satisfaction Surveys
Time Frame: From enrollment to end of follow up at 15 weeks
We will assess acceptability as reflected in the average caregiver and adolescent satisfaction rating measured using two study-specific measures. Caregivers will complete the Caregiver Readiness and Satisfaction Survey (CRS) and adolescents will complete the Adolescent Readiness and Satisfaction Survey (ARS).
From enrollment to end of follow up at 15 weeks
Clinician Global Impressions - Improvement (CGI-I)
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
A trained, independent clinician will rate the CGI at T3 and T5. The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Emotion Regulation Skills Test
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Caregiver-report measures to measure change in internalizing symptoms. For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Aberrant Behavior Checklist, 2nd Edition (ABC-2)
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors. Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Parenting Stress Index, 4th Edition, Short Form
Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system. Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Mercy Hospital Kansas City

Collaborators

Foundation for Prader-Willi Research

Investigators

  • Principal Investigator: Walker McKinney, PhD, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00004042
  • 1568503 (Other Grant/Funding Number: Foundation for Prader-Willi Research)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Risk for participant identification due to small sample and narrow geographic area

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prader-Willi Syndrome

Clinical Trials on Regulating Together group therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe