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

NCT07607730 | Recruiting

• 2 other identifiers: STUDY000040421568503
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prader-Willi Syndrome

Keywords

Prader-Willi Syndrome; Emotion dysregulation; aggression; anxiety; depression; hyperphagia

Outcome Measures

Primary Outcomes (1)

• Emotion Dysregulation Inventory - Reactivity

  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 Outcomes (6)

• Caregiver and Adolescent Readiness and Satisfaction Surveys

  From enrollment to end of follow up at 15 weeks

• Emotion Regulation Skills Test

  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)

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

• Aberrant Behavior Checklist, 2nd Edition (ABC-2)

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

• Clinician Global Impressions - Improvement (CGI-I)

  From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Study Arms (1)

Teens with Prader-Willi Syndrome and their caregiver

EXPERIMENTAL

Participants will receive Regulating Together - the emotion dysregulation intervention

Behavioral: Regulating Together group therapy

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.

Teens with Prader-Willi Syndrome and their caregiver

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• Foundation for Prader-Willi Research: collaborator

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64108, United States

RECRUITING

Related Links

• Children's Mercy Find a Study page
• Sponsor website

MeSH Terms

Conditions

Prader-Willi Syndrome; Aggression; Anxiety Disorders; Depression; Hyperphagia

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Walker McKinney, PhD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grayson Manley, RN

CONTACT

816-816-6967; gmanley@cmh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)