Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation

Children's Mercy Hospital Kansas City10 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Autism Intellectual Disabilities With Other Behavioral Symptoms

Eligibility

Sex: ALLMin age: 8 YearsMax age: 12 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Emotion Dysregulation Inventory - Reactivity

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.

Time frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Secondary Outcomes

Caregiver and Child Readiness and Satisfaction Surveys

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.

Time frame: From enrollment to end of follow up at 15 weeks

Emotion Regulation Skills Test

A child self-report measure created for Regulating Together to measure knowledge of skills taught to manage emotion dysregulation.

Time frame: 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)

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

Time frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Clinician Global Impressions - Improvement (CGI-I)

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.

Time frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Parenting Stress Index, 4th Edition, Short Form

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

Time frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Aberrant Behavior Checklist, 2nd Edition (ABC-2)

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

Time frame: From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed

Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts