Regulating Together for Intellectual Disability and Autism: A Group Behavioral Therapy for for Emotion Dysregulation
Purpose
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.
Conditions
- Autism
- Intellectual Disabilities With Other Behavioral Symptoms
- Intellectual Disability
Eligibility
- Eligible Ages
- Between 8 Years and 12 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Children with autism and co-occurring intellectual disability and their caregiver |
Participants will receive Regulating Together - the emotion dysregulation intervention |
|
Recruiting Locations
Kansas City, Missouri 64108
More Details
- Status
- Recruiting
- Sponsor
- Children's Mercy Hospital Kansas City
Detailed Description
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.