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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Children's Mercy Hospital Kansas City • ClinicalTrials.gov ID: NCT07607730

Registry updated: 2026-09-02
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Description

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

  • 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.

Eligibility criteria

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

Conditions

Prader-Willi Syndrome

Locations

  • Children's Mercy — Kansas City, Missouri, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record