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

1 september 2026 bijgewerkt door: 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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Grayson Manley, RN
  • Telefoonnummer: 816-816-6967
  • E-mail: gmanley@cmh.edu

Studie Locaties

    • Missouri
      • Kansas City, Missouri, Verenigde Staten, 64108
        • Werving
        • Children's Mercy
        • Contact:
        • Hoofdonderzoeker:
          • Walker McKinney, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Children with autism and co-occurring intellectual disability and their caregiver
Participants will receive Regulating Together - the emotion dysregulation intervention
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Emotion Dysregulation Inventory - Reactivity
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Clinician Global Impressions - Improvement (CGI-I)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 oktober 2027

Primaire voltooiing (Geschat)

1 juni 2028

Studie voltooiing (Geschat)

1 augustus 2028

Studieregistratiedata

Eerst ingediend

28 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 mei 2026

Eerst geplaatst (Werkelijk)

3 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 september 2026

Laatste update ingediend die voldeed aan QC-criteria

1 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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