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

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.

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.

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