Improving Hospitalizations for Children With ASD

Study Overview
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Brief Summary
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This study aims to implement and test a specific brief Applied Behavior Analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with ASD. The investigators will evaluate the impact of this program by conducting a randomized trial across both medical and psychiatric hospital settings.

Official Title
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Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention

Conditions
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Autism Spectrum Disorder, Autistic Disorder

Intervention / Treatment
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* Behavioral: Brief Analogue Functional Analysis
* Other: No Brief AFA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: documented diagnosis of an ASD based on clinical DSM-5 diagnostic criteria assessed by attending psychiatrist the presence of a significant challenging behaviors (e.g., aggression, property destruction, self-injury, elopement) admission to the VPH or medical floors individual and caregiver agreement to participate and ability to provide informed consent (and assent). Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABA Treatment Group<br>20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive Brief Analogue Functional Analysis (Brief AFA) targeted to their most problematic behavior(s) while hospitalized | Behavioral: Brief Analogue Functional Analysis<br>* The Brief AFA seeks to identify the function of the challenging behavior by creating controlled test conditions in which specific responses are provided for challenging behavior (e.g., attention, escape from task demands, access to tangible - including variants of each as needed), as well as a control condition in which continual access to attention and preferred items is provided. It consists of a 30-90-minute abbreviated analysis comprised of a single exposure to 2-5-minute test and control conditions, along with replication of applicable test conditions and a treatment probe, which provides evidence of challenging behavior function faster than other methods.<br>|
| Other: Control Group<br>20 Children - 10 hospitalized at Vanderbilt Children's Hospital and 10 hospitalized at Vanderbilt Psychiatric hospital - will receive all typical standard of care procedures while hospitalized, but will not receive Brief AFA | Other: No Brief AFA<br>* These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist | The ABC is a well-validated measure designed to assess for the presence of clinically significant challenging behavior in the areas of irritability and agitation, lethargy and social withdrawal, stereotypic behavior, hyperactivity and noncompliance, and inappropriate speech. | Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge | 
| Decrease in Length of Hospitalization | Reduction in the days hospitalized past medical clearance). | Participants will be followed from admission to discharge, an expected average of 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Scales of Severity | Attending physician's impressions of participant's clinical impairment and improvement. | Baseline and Day of Patient's Discharge (an expected average of 42 days from admission) | 
| Blinded Observational Ratings | Blinded coding of the challenging behaviors targeted in the treatment arm | Participants will be followed for duration of hospital stay, an expected average of 42 days | 
| Physician/Nurse/Family Perception of Care | The primary medical attending, lead discharge nurse staff member, and the child's primary parent will also be asked at discharge to provide both quantitative and qualitative ratings of challenges and successes during hospitalization. Caregivers will be contacted to complete a simple interview/questionnaire 3- months post-hospitalization regarding changes in the patient's medication, medical conditions, residential/classroom placement, emergency room visits or psychiatric hospitalizations since the discharge date, as well as ratings of successes implementing components of the behavioral strategies plan utilized during the hospitalization (if applicable). | Day of Patient's Discharge (an expected average of 42 days from admission) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, Autism