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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002367 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with autism and co-occurring intellectual disability and their caregiver | Experimental | Participants will receive Regulating Together - the emotion dysregulation intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Regulating Together group therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to end of follow up at 15 weeks |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grayson Manley, RN | Contact | 816-816-6967 | gmanley@cmh.edu |
| Name | Affiliation | Role |
|---|---|---|
| Walker McKinney, PhD | Children's Mercy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy | Recruiting | Kansas City | Missouri | 64108 | United States |
Risk for participant identification due to small sample and narrow geographic area
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| Emotion Regulation Skills Test | 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) | 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 |
| 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. | 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 | 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 | From enrollment to the end of their follow up appointment, about 10 weeks after therapy has completed |
| ID | Term |
|---|---|
| D001321 | Autistic Disorder |
| D008607 | Intellectual Disability |
| D000374 | Aggression |
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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