Recruiting

Emotional Regulation

Sponsor:

Children's Mercy Hospital Kansas City

Code:

NCT07607730

Conditions

Prader-Willi Syndrome

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

Regulating Together group therapy

Study Details

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.

Conditions

Prader-Willi Syndrome

Study ID

NCT07607730

Start date

Jan, 2027

Status verified date

Aug, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Teens with Prader-Willi Syndrome and their caregiver

Participants will receive Regulating Together - the emotion dysregulation intervention

Interventions

Regulating Together group therapy

Regulating Together is the original curriculum developed for autistic youth that uses evidence-based therapeutic strategies including relaxation techniques, parent management training, and mindfulness to help regulate emotions. This study will adapt the original Regulating Together curriculum to focus on behavioral interventions to treat emotion dysregulation in Prader-Willi Syndrome.

Primary outcome measure

  • Emotion Dysregulation Inventory - Reactivity [ Time Frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed ]

Central Contacts and Locations

Central contacts

Grayson Manley, RN

816-816-6967gmanley@cmh.edu

Locations

Children's Mercy

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Grayson Manley, RN

816-816-6967gmanley@cmh.edu

Walker McKinney, PhD

816-234-3656wsmckinney@cmh.edu

Principal Investigator:

Walker McKinney, PhD

More Information

Sponsor

Children's Mercy Hospital Kansas City

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Prader-Willi Syndrome
  • Emotion dysregulation
  • aggression
  • anxiety
  • depression
  • hyperphagia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Mercy Hospital Kansas City on 2026-09-02.