Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Hospitalizations for Children With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02339935
Recruitment Status : Completed
First Posted : January 16, 2015
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin Sanders, Vanderbilt University

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
Autism Spectrum Disorder Autistic Disorder Behavioral: Brief Analogue Functional Analysis Other: No Brief AFA Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


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.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02339935


Locations
Layout table for location information
United States, Tennessee
Vanderbilt University Medical Center - MEND Clinic
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Kevin Sanders, MD MEND Clinic - Director
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Kevin Sanders, Principal Investigator, Vanderbilt University
ClinicalTrials.gov Identifier: NCT02339935    
Other Study ID Numbers: 141265
First Posted: January 16, 2015    Key Record Dates
Last Update Posted: April 27, 2016
Last Verified: September 2015
Keywords provided by Kevin Sanders, Vanderbilt University:
Autism Spectrum Disorder
Autism
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Autistic Disorder
Autism Spectrum Disorder
Pathologic Processes
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders