- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07624448
Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation (RT-ID)
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
Statut
Les conditions
Intervention / Traitement
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
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Grayson Manley, RN
- Numéro de téléphone: 816-816-6967
- E-mail: gmanley@cmh.edu
Lieux d'étude
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Missouri
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Kansas City, Missouri, États-Unis, 64108
- Recrutement
- Children's Mercy
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Contact:
- Grayson Manley, RN
- Numéro de téléphone: 816-816-6967
- E-mail: gmanley@cmh.edu
-
Chercheur principal:
- Walker McKinney, PhD
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
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
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.
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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
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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.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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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
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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.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Emotion Regulation Skills Test
Délai: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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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
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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
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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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
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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
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
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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
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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
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From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed
|
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Caregiver and Child Readiness and Satisfaction Surveys
Délai: From enrollment to end of follow up at 15 weeks
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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.
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From enrollment to end of follow up at 15 weeks
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Walker McKinney, PhD, Children's Mercy
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Troubles du spectre autistique
- Comportement moteur aberrant dans la démence
- Manifestations neurologiques
- Maladies du système nerveux
- Les troubles mentaux
- Symptômes comportementaux
- Manifestations neurocomportementales
- Troubles neurodéveloppementaux
- Troubles envahissants du développement de l'enfant
- Conditions pathologiques, signes et symptômes
- Comportement
- Signes et symptômes
- Comportement social
- Trouble autistique
- Déficience intellectuelle
- Agression
Autres numéros d'identification d'étude
- STUDY00004069
- KL2TR002367 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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