Improving Hospitalizations for Children With ASD

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Autistic Disorder
• Intervention / Treatment: Behavioral: Brief Analogue Functional Analysis; Other: No Brief AFA

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Vanderbilt University Medical Center - MEND Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABA Treatment Group; 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; 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.
Other: Control Group; 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; These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Kevin Sanders, MD, MEND Clinic - Director

Publications and helpful links

General Publications

• Sanders K, Staubitz J, Juarez AP, Marler S, Browning W, McDonnell E, Altstein L, Macklin EA, Warren Z. Addressing Challenging Behavior During Hospitalizations for Children with Autism: A Pilot Applied Behavior Analysis Randomized Controlled Trial. Autism Res. 2020 Jul;13(7):1072-1078. doi: 10.1002/aur.2308. Epub 2020 Apr 23.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: January 15, 2015
• First Posted (Estimate): January 16, 2015

Study Record Updates

• Last Update Posted (Estimate): April 27, 2016
• Last Update Submitted That Met QC Criteria: April 26, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Autism; Autism Spectrum Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Disease; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 141265