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

Purpose

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.

Condition

  • Prader-Willi Syndrome

Eligibility

Eligible Ages
Between 13 Years and 17 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Children's Mercy
Kansas City, Missouri 64108
Contact:
Grayson Manley, RN
816-816-6967
gmanley@cmh.edu

More Details

Status
Recruiting
Sponsor
Children's Mercy Hospital Kansas City

Study Contact

Grayson Manley, RN
816-816-6967
gmanley@cmh.edu

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.