Improving Hospitalizations for Children With ASD

NCT ID: NCT02339935

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Autism Spectrum Disorder Autistic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Brief Analogue Functional Analysis

Intervention Type 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.

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

Group Type OTHER

No Brief AFA

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

No Brief AFA

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Kevin Sanders

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kevin Sanders, MD

Role: PRINCIPAL_INVESTIGATOR

MEND Clinic - Director

Locations

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Vanderbilt University Medical Center - MEND Clinic

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32329237 (View on PubMed)

Other Identifiers

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141265

Identifier Type: -

Identifier Source: org_study_id

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