Improving Hospitalizations for Children With ASD

Not Applicable

Completed

• Conditions: Autistic Disorder; Autism Spectrum Disorder

• Registration Number: NCT02339935
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-30
• Study Start: 2015-01
• Study First Submitted QC: 2015-01-15
• Study First Posted: 2015-01-16
• Status Verified: 2015-09
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2016-04-26
• Last Update Posted: 2016-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Aberrant Behavior Checklist	Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge	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.
Decrease in Length of Hospitalization	Participants will be followed from admission to discharge, an expected average of 42 days	Reduction in the days hospitalized past medical clearance).

Secondary Outcome Measures

Name	Time	Method
Blinded Observational Ratings	Participants will be followed for duration of hospital stay, an expected average of 42 days	Blinded coding of the challenging behaviors targeted in the treatment arm
Physician/Nurse/Family Perception of Care	Day of Patient's Discharge (an expected average of 42 days from admission)	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).
Clinical Global Impression Scales of Severity	Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)	Attending physician's impressions of participant's clinical impairment and improvement.

Trial Locations

Locations (1)

Vanderbilt University Medical Center - MEND Clinic; 🇺🇸 Nashville, Tennessee, United States