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

NCT07607730

RecruitingNA

Sponsor: Children's Mercy Hospital Kansas City

Conditions: Prader-Willi Syndrome

Interventions: Regulating Together group therapy

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 13 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (1)
  • Kansas City, Missouri, United States