NCT07607730 Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
| NCT ID | NCT07607730 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Mercy Hospital Kansas City |
| Condition | Prader-Willi Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-08 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Walker McKinney, PhD
PRINCIPAL INVESTIGATOR
Children's Mercy
Frequently Asked Questions
Who can join the NCT07607730 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 17 Years, studying Prader-Willi Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607730 currently recruiting?
Yes, NCT07607730 is actively recruiting participants. Contact the research team at gmanley@cmh.edu for enrollment information.
Where is the NCT07607730 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT07607730 clinical trial?
NCT07607730 is sponsored by Children's Mercy Hospital Kansas City. The principal investigator is Walker McKinney, PhD at Children's Mercy. The trial plans to enroll 10 participants.