Children's Mercy
Kansas City, Missouri, 64108, United States
Location status: Recruiting
Location contact
Grayson Manley, RN
CONTACT
Walker McKinney, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07624448
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.
Interested in participating?
Request Info8 year–12 year
All sexes
Interventional
Not applicable
Kansas City, Missouri, 64108, United States
Location status: Recruiting
Grayson Manley, RN
CONTACT
Walker McKinney, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Child Participant Inclusion Criteria:
Child Participant Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
-Presence of any major sensory impairment that would limit participating in the material including blindness or uncorrected hearing loss
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Children's Mercy Hospital Kansas City
Other
Adapting a Group Intervention for Emotion Dysregulation in Autism and Intellectual Disability
Acronym: RT-ID
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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