Skip to main content
OpenTrials
Completed

NCT Number: NCT02339935

Improving Hospitalizations for Children With ASD

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center - MEND Clinic

Nashville, Tennessee, 37212, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

No Brief AFA

Other

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

Primary outcomes

  1. Aberrant Behavior Checklist

    Time frame: 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

    Time frame: Participants will be followed from admission to discharge, an expected average of 42 days

    Reduction in the days hospitalized past medical clearance).

Secondary outcomes

  1. Clinical Global Impression Scales of Severity

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2015
Registry last updated
Apr 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.