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Improving Hospitalizations for Children With ASD

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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

Tracking Information
First Submitted Date  ICMJE December 30, 2014
First Posted Date  ICMJE January 16, 2015
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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.
  • 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2015)
  • 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.
  • 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
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Hospitalizations for Children With ASD
Official Title  ICMJE Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Autism Spectrum Disorder
  • Autistic Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Behavioral: Brief Analogue Functional Analysis
  • 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
    Intervention: Other: No Brief AFA
Publications * Sanders K, Staubitz J, Juárez 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2016)
36
Original Estimated Enrollment  ICMJE
 (submitted: January 15, 2015)
40
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02339935
Other Study ID Numbers  ICMJE 141265
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kevin Sanders, Vanderbilt University
Study Sponsor  ICMJE Vanderbilt University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kevin Sanders, MD MEND Clinic - Director
PRS Account Vanderbilt University
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP