AzTrials
AzTrials

Prader-Willi SyndromeRT-PWSNCT07607730

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

A study testing Regulating Together group therapy in people with Prader-Willi Syndrome, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Prader-Willi Syndrome
What is being tested?
Regulating Together group therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Jan 2027to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grayson Manley, RN contact

816-816-6967

gmanley@cmh.edu

United States1 site, 1 recruiting

  • Children's Mercy

    Kansas City, Missouri, 64108

    Grayson Manley, RN, 816-816-6967, gmanley@cmh.edu

    Walker McKinney, PhD, 816-234-3656, wsmckinney@cmh.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

Up to ten children with Prader-Willi Syndrome (PWS) ages 13 to 17.5 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help teenagers with PWS calm their emotions. Participants will complete assessments at five time points:

Screening (T1); Week 0: Baseline visit (T2); Week 5: Post Active Treatment (T3); Week 10: 5 week follow-up (T4); and Week 15: 10 week follow-up (T5). Participants will receive 5 weeks of intervention, twice per week, following the T2 visit.

Being tested
Regulating Together group therapy
Keywords
Prader-Willi Syndrome, Emotion dysregulation, aggression, anxiety, depression, hyperphagia
Medical subject headings
Prader-Willi Syndrome, Aggression, Anxiety Disorders, Depression, Hyperphagia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regulating Together group therapyBehavioural

    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.

Study groups in NCT07607730
Study groupRoleWhat they receive
Teens with Prader-Willi Syndrome and their caregiverExperimentalParticipants will receive Regulating Together - the emotion dysregulation intervention
Receives: Behavioral: Regulating Together group therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Emotion Dysregulation Inventory - Reactivity

    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.

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Secondary outcomes (6)

  1. Caregiver and Adolescent Readiness and Satisfaction Surveys

    We will assess acceptability as reflected in the average caregiver and adolescent satisfaction rating measured using two study-specific measures. Caregivers will complete the Caregiver Readiness and Satisfaction Survey (CRS) and adolescents will complete the Adolescent Readiness and Satisfaction Survey (ARS).

    Measured: From enrollment to end of follow up at 15 weeks

  2. Emotion Regulation Skills Test

    A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)

    Caregiver-report measures to measure change in internalizing symptoms. For both measures: minimum raw value: 13; maximum raw value: 65; higher scores reflect greater anxiety/depression

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

  4. Aberrant Behavior Checklist, 2nd Edition (ABC-2)

    Irritability subscale; a caregiver-report measures to measure change in irritability and related challenging behaviors. Minimum score: 0; Maximum score: 45; higher scores reflect greater irritability

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

  5. Clinician Global Impressions - Improvement (CGI-I)

    A trained, independent clinician will rate the CGI at T3 and T5. The CGI-I provides a qualitative measure of treatment response through a rating from 1=very much improved to 7=very much worse.

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

  6. Parenting Stress Index, 4th Edition, Short Form

    A caregiver-report questionnaire measuring the magnitude of stress in the parent-child system. Minimum score: 36; Maximum score: 180; Higher scores reflect greater parental stress

    Measured: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07607730
Sponsor's protocol ID
STUDY00004042
Other IDs
1568503
Acronym
RT-PWS
Status last verified
Aug 2026
First submitted
19 May 2026
Last updated
2 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Risk for participant identification due to small sample and narrow geographic area

Questions about this trial

What is this clinical trial studying?

A study testing Regulating Together group therapy in people with Prader-Willi Syndrome, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Grayson Manley, RN (816-816-6967, gmanley@cmh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07607730.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in