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

This study is testing a group therapy called "Regulating Together" to help teenagers with Prader-Willi Syndrome (PWS) and their families manage strong emotions like irritability, meltdowns, and anxiety. This therapy uses techniques like relaxation, parent training, and mindfulness. The study aims to improve how teens with PWS handle their emotions. To join, you must be 13 to 17.5 years old, have a confirmed genetic diagnosis of PWS, speak English fluently, and be willing to attend weekly group sessions. The study will measure changes in emotion regulation using a tool called the Emotion Dysregulation Inventory - Reactivity. The study is currently unclear about its status and plans to enroll up to 10 participants.

Study design
This is an interventional study with up to 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would attend 5 weeks of group therapy, twice per week. You would also complete assessments at screening, baseline, after treatment, and at 5-week and 10-week follow-ups.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about 10 weeks after therapy has completed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07607730

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

Recruiting
NAAges 13–17InterventionalTreatment
Children's Mercy Hospital Kansas City
~10 participants
Updated 2026-09-02 on ClinicalTrials.gov
What's tested:Regulating Together group therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Emotion Dysregulation Inventory - Reactivity
Measured over From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Conditions

Prader-Willi Syndrome

Explore related trials

Emotional dysregulationPrader-Willi SyndromePrader-Willi Syndrome

NCT07607730

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Mercy

    Kansas City, Missouristudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Walker McKinney, PhD · PRINCIPAL_INVESTIGATOR · Children's Mercy

Who to contact

Grayson Manley, RN
[email protected]
816-816-6967
Email the study team

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Eligibility criteria

Inclusion

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
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

Exclusion

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
Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss

What this trial measures

  • Emotion Dysregulation Inventory - ReactivityFrom enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

    The Emotion Dysregulation Inventory consists of two subscales. We will use the Reactivity subscale which captures poorly regulated negative emotional responses and a dysphoria subscale characterized by increased negative affect and lack of motivation. Minimum raw score: 0; Maximum raw score: 96; Higher scores reflect higher emotional reactivity.