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Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)

3. Juni 2026 aktualisiert von: Walker McKinney, Children's Mercy Hospital Kansas City

Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability

The goal of this study is to help children with autism and a co-occurring intellectual disability and their families learn practical strategies for managing issues like irritability, aggression, and other challenging behaviors. The main objective of this study is:

To adapt current Regulating Together materials to create an outpatient group program for emotion dysregulation in autism and co-occurring intellectual disability (ASD + ID) that will improve psychosocial outcomes for youth with ASD + ID.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Up to ten children with autism and co-occurring Intellectual Disability (ASD + ID) ages 8 to 12 years and their caregivers will be enrolled in the study. This study is being done to develop and test a behavior therapy to help children with ASD + ID 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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

10

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studienorte

  • Vereinigte Staaten
    • Missouri
      • Kansas City, Missouri, Vereinigte Staaten, 64108
        • Rekrutierung
        • Children's Mercy
        • Kontakt:
        • Hauptermittler:
          • Walker McKinney, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Child Participant Inclusion Criteria:

  • Males, females, or non-binary youth between 8 and 12 years of age
  • Confirmed diagnosis of Autism Spectrum Disorder (ASD)
  • Confirmed diagnosis of Intellectual Disability
  • Fluent in spoken English.
  • Use of flexible phrase speech or greater
  • Meeting clinically significant emotion dysregulation criteria
  • Willing to participate in twice weekly 90-minute sessions
  • Family is willing to keep prescribed psychiatric medication and outside behavioral interventions stable
  • Parent, guardian, or legally authorized representative (LAR) 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 child directed towards a peer outside the home (i.e., non-siblings) that resulted in injury within 30 days prior to screening. Other significant disruptive, aggressive, self-injurious, or sexually inappropriate behavior felt to be dangerous or overly disruptive to the group sessions will be reviewed by the study team on an individual basis.
  • 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 ASD+ID 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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
Verhalten: 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 Autism with a co-occurring intellectual disability.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Emotion Dysregulation Inventory - Reactivity
Zeitfenster: 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. The investigators 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Clinician Global Impressions - Improvement (CGI-I)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Caregiver and Child Readiness and Satisfaction Surveys
Zeitfenster: From enrollment to end of follow up at 15 weeks
The investigators will assess acceptability as reflected in the average caregiver and child satisfaction rating measured using two study-specific measures. Caregivers will complete the Caregiver Readiness and Satisfaction Survey and children will complete the Child Readiness and Satisfaction Survey.
From enrollment to end of follow up at 15 weeks

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Children's Mercy Hospital Kansas City

Mitarbeiter

National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Oktober 2026

Primärer Abschluss (Geschätzt)

1. September 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Mai 2026

Zuerst gepostet (Tatsächlich)

3. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00004069
  • KL2TR002367 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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