Improving Hospitalizations for Children With ASD

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02339935
• Other study ID #: 141265
• Status: Completed
• Phase: N/A
• First received: December 30, 2014
• Last updated: April 26, 2016
• Start date: January 2015
• Est. completion date: November 2015

Study information

• Verified date: September 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

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:
• No Brief AFA
These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center - MEND Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Clinical Global Impression Scales of Severity	Attending physician's impressions of participant's clinical impairment and improvement.	Baseline and Day of Patient's Discharge (an expected average of 42 days from admission)	No
Secondary	Blinded Observational Ratings	Blinded coding of the challenging behaviors targeted in the treatment arm	Participants will be followed for duration of hospital stay, an expected average of 42 days	No
Secondary	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).	Day of Patient's Discharge (an expected average of 42 days from admission)	No