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Improving Hospitalizations for Children With ASD

Primary Purpose

Autism Spectrum Disorder, Autistic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Analogue Functional Analysis
No Brief AFA
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, Autism

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Medical Center - MEND Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

ABA Treatment Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
Decrease in Length of Hospitalization
Reduction in the days hospitalized past medical clearance).

Secondary Outcome Measures

Clinical Global Impression Scales of Severity
Attending physician's impressions of participant's clinical impairment and improvement.
Blinded Observational Ratings
Blinded coding of the challenging behaviors targeted in the treatment arm
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).

Full Information

First Posted
December 30, 2014
Last Updated
April 26, 2016
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT02339935
Brief Title
Improving Hospitalizations for Children With ASD
Official Title
Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autistic Disorder
Keywords
Autism Spectrum Disorder, Autism

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABA Treatment Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Other
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Brief Analogue Functional Analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Brief AFA
Intervention Description
These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention
Primary Outcome Measure Information:
Title
Aberrant Behavior Checklist
Description
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.
Time Frame
Change from Baseline ABC at Hospital Discharge (an expected average of 42 days) and 3-Months Post-Discharge
Title
Decrease in Length of Hospitalization
Description
Reduction in the days hospitalized past medical clearance).
Time Frame
Participants will be followed from admission to discharge, an expected average of 42 days
Secondary Outcome Measure Information:
Title
Clinical Global Impression Scales of Severity
Description
Attending physician's impressions of participant's clinical impairment and improvement.
Time Frame
Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)
Title
Blinded Observational Ratings
Description
Blinded coding of the challenging behaviors targeted in the treatment arm
Time Frame
Participants will be followed for duration of hospital stay, an expected average of 42 days
Title
Physician/Nurse/Family Perception of Care
Description
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).
Time Frame
Day of Patient's Discharge (an expected average of 42 days from admission)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Sanders, MD
Organizational Affiliation
MEND Clinic - Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center - MEND Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32329237
Citation
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.
Results Reference
derived

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Improving Hospitalizations for Children With ASD

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