Group therapy to help teens with Prader-Willi regulate emotions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study adapts the Regulating Together program into an outpatient group therapy for emotion dysregulation in adolescents with Prader-Willi Syndrome. Up to ten participants aged 13 to 17.5 years and their caregivers will complete assessments at five time points: baseline, post-treatment, and two follow-ups. The intervention consists of five weeks of group sessions, held twice weekly, focusing on practical strategies to manage irritability, meltdowns, and anxiety. The study aims to improve psychosocial outcomes by teaching emotion regulation in a structured, family-inclusive setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Mercy
  Kansas City, Missouri, United States Recruiting

Study contacts

• Principal investigator: Walker McKinney, PhD — Children's Mercy
• Study coordinator: Grayson Manley, RN
• Email: gmanley@cmh.edu
• Phone: 816-816-6967

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.