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Recruiting
NCT07607730
Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
Conditions: Prader-Willi Syndrome
Sex: All
Ages: 13 Years – 17 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: Children's Mercy Hospital Kansas City
Location: Children's Mercy Kansas City Missouri
Summary
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 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
Source: ClinicalTrials.gov (NCT07607730). StuddyBuddy aggregates publicly available trial information.