Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
Recruiting · NCT07607730 · Interventional (participants receive a specific treatment) · Lead sponsor: Children's Mercy Hospital Kansas City
View the official record on ClinicalTrials.gov →Interventions studied
Regulating Together group therapy
What this trial is about
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.
Who can take part
Age range
13 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Children's Mercy - Kansas City, Missouri, United States