Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation (RT-PWS)

Children's Mercy Hospital Kansas City

Status

Enrolling

Conditions

Prader-Willi Syndrome

Treatments

Behavioral: Regulating Together group therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07607730

STUDY00004042

1568503 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment

10 estimated patients

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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