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Regulating Together for Prader-Willi Syndrome: A Group Behavioral Therapy for Emotion Dysregulation (RT-PWS)

31 augusti 2026 uppdaterad av: Walker McKinney, Children's Mercy Hospital Kansas City

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

10

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Grayson Manley, RN
  • Telefonnummer: 816-816-6967
  • E-post: gmanley@cmh.edu

Studieorter

  • Förenta staterna
    • Missouri
      • Kansas City, Missouri, Förenta staterna, 64108
        • Rekrytering
        • Children's Mercy
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Walker McKinney, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn

Tar emot friska volontärer

Nej

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Teens with Prader-Willi Syndrome and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
Beteende: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Emotion Dysregulation Inventory - Reactivity
Tidsram: From 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.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Caregiver and Adolescent Readiness and Satisfaction Surveys
Tidsram: From enrollment to end of follow up at 15 weeks
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).
From enrollment to end of follow up at 15 weeks
Clinician Global Impressions - Improvement (CGI-I)
Tidsram: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Emotion Regulation Skills Test
Tidsram: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depression Scales (Parent-Proxy)
Tidsram: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Aberrant Behavior Checklist, 2nd Edition (ABC-2)
Tidsram: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
Parenting Stress Index, 4th Edition, Short Form
Tidsram: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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
From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Children's Mercy Hospital Kansas City

Samarbetspartners

Foundation for Prader-Willi Research

Utredare

  • Huvudutredare: Walker McKinney, PhD, Children's Mercy

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 januari 2027

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

19 maj 2026

Först inskickad som uppfyllde QC-kriterierna

19 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00004042
  • 1568503 (Annat bidrag/finansieringsnummer: Foundation for Prader-Willi Research)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

Risk for participant identification due to small sample and narrow geographic area

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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