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.
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
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
Single group
Regulating Together group therapy
BehavioralRegulating 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.
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.
Caregiver and Adolescent Readiness and Satisfaction Surveys
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).
Emotion Regulation Skills Test
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
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
Aberrant Behavior Checklist, 2nd Edition (ABC-2)
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
Click on the lead sponsor to view all of their trials.
Children's Mercy Hospital Kansas City
Lead sponsor
Foundation for Prader-Willi Research
Collaborator
