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

1 septembre 2026 mis à jour par: 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.

Aperçu de l'étude

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

10

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Grayson Manley, RN
  • Numéro de téléphone: 816-816-6967
  • E-mail: gmanley@cmh.edu

Lieux d'étude

    • Missouri
      • Kansas City, Missouri, États-Unis, 64108
        • Recrutement
        • Children's Mercy
        • Contact:
          • Grayson Manley, RN
          • Numéro de téléphone: 816-816-6967
          • E-mail: gmanley@cmh.edu
        • Chercheur principal:
          • Walker McKinney, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Emotion Dysregulation Inventory - Reactivity
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clinician Global Impressions - Improvement (CGI-I)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Walker McKinney, PhD, Children's Mercy

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2027

Achèvement primaire (Estimé)

1 juin 2028

Achèvement de l'étude (Estimé)

1 août 2028

Dates d'inscription aux études

Première soumission

28 mai 2026

Première soumission répondant aux critères de contrôle qualité

28 mai 2026

Première publication (Réel)

3 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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