Improving Hospitalizations for Children With ASD

NCT02339935 | Completed

• 1 other identifier: 141265
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder; Autistic Disorder

Keywords

Autism Spectrum Disorder; Autism

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Clinical Global Impression Scales of Severity

  Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)

• Blinded Observational Ratings

  Participants will be followed for duration of hospital stay, an expected average of 42 days

• Physician/Nurse/Family Perception of Care

  Day of Patient's Discharge (an expected average of 42 days from admission)

Study Arms (2)

ABA Treatment Group

EXPERIMENTAL

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

Control Group

OTHER

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

Interventions

Brief Analogue Functional Analysis BEHAVIORAL

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.

ABA Treatment Group

No Brief AFA OTHER

These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center - MEND Clinic

Nashville, Tennessee, 37212, United States

Location

Related Publications (1)

• 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.

  PMID: 32329237 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Kevin Sanders, MD

  MEND Clinic - Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 16, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 27, 2016

Record last verified: 2015-09

Locations

US (1)