ClinicalTrials.gov record NCT07607730
Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation
Adapting a Group Intervention for Emotion Dysregulation in Prader-Willi Syndrome
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study adapts and tests Regulating Together, a group behavioral therapy, for teenagers with Prader‑Willi syndrome and their caregivers. Up to ten teen–caregiver pairs will receive five weeks of twice-weekly 90-minute group sessions and complete assessments at screening, baseline, post-treatment, and two follow-ups. The study will collect measures of emotion dysregulation, caregiver and adolescent satisfaction, anxiety, depression, irritability, clinician-rated change, and parenting stress.
What it is studying. The study is testing an outpatient, adapted version of the Regulating Together group curriculum to address emotion dysregulation in adolescents with Prader‑Willi syndrome. It will measure changes in emotional reactivity and related psychosocial outcomes and assess acceptability and skill learning for both adolescents and caregivers.
What the researchers hope to learn. Adapt the Regulating Together curriculum for outpatient group delivery in Prader‑Willi syndrome; measure emotion dysregulation using the Emotion Dysregulation Inventory (Reactivity); assess acceptability via caregiver and adolescent satisfaction surveys; evaluate skill knowledge, parent-reported anxiety and depression (PROMIS), irritability (Aberrant Behavior Checklist-2), clinician global impressions of improvement, and parenting stress.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Behavioral
- Regulating Together group therapy
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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 description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
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.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
The teen and their caregiver will join the adapted Regulating Together group program and complete assessments at five time points (screening, baseline, post-treatment, and two follow-ups). The intervention is delivered over 5 weeks and, per the study description, participants will receive sessions twice weekly; sessions are 90 minutes and caregivers are expected to join one session virtually each week. Participants will complete questionnaires and skill‑knowledge measures, and independent clinician ratings are collected at specified visits. Families need to keep current psychiatric medications and outside behavioral treatments stable while enrolled.
How the study is structured. Interventional, single-group study with no masking: all enrolled teens and their caregivers receive the same behavioral group program. Participants attend five weeks of twice-weekly 90-minute group sessions (one session per week for caregivers may be virtual) and complete assessments at screening, baseline (week 0), post-treatment (week 5), and two follow-ups (about 5 and 10 weeks after treatment ends).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Prader-Willi syndrome
Important dates
- Study start
- January 2027 (estimated)
- Primary completion
- September 2027 (estimated)
- Study completion
- November 2027 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- Sep 2, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Principal investigator
- Walker McKinney, Assistant Professor
Children's Mercy Hospital Kansas City - Collaborators
- Foundation for Prader-Willi Research
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Grayson Manley, RN 📞 816-816-6967 ✉ gmanley@cmh.edu
Participating sites (1)
- Children's MercyRecruiting
Kansas City, Missouri, 64108 · United States
- Grayson Manley, RN · 816-816-6967 · gmanley@cmh.edu
- Walker McKinney, PhD · 816-234-3656 · wsmckinney@cmh.edu
- Walker McKinney, PhD
Terms used on this page · explanations by MedicalUpdates.ai
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- legally authorized representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- prior to screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Baseline
- Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
- follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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