Improving Hospitalizations for Children With ASD

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT02339935
Collaborator
(none)
36
1
2
10
3.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Brief Analogue Functional Analysis
  • Other: No Brief AFA
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  1. 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.

  2. 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

  3. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center - MEND Clinic Nashville Tennessee United States 37212

Sponsors and Collaborators

  • Vanderbilt University

Investigators

  • Principal Investigator: Kevin Sanders, MD, MEND Clinic - Director

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Kevin Sanders, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT02339935
Other Study ID Numbers:
  • 141265
First Posted:
Jan 16, 2015
Last Update Posted:
Apr 27, 2016
Last Verified:
Sep 1, 2015
Keywords provided by Kevin Sanders, Principal Investigator, Vanderbilt University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2016