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NCT07607730Recruiting

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

Adapting a Group Intervention for Emotion Dysregulation in Prader-Willi Syndrome

Source: ClinicalTrials.gov · Last updated 2 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
10 (estimated)
First submitted
19 May 2026
Start date
Jan 2027
Primary completion date
Sept 2027
Lead sponsor
Children's Mercy Hospital Kansas City
NCT number
NCT07607730

What you commit to

  • Study type: Interventional
  • Planned participants: 10
  • From Jan 2027 to the primary completion date, Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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

Age in the registry: 13 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Children's Mercy
Coordinator of this site? Confirm its status
Kansas CityUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.