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
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Autistic Disorder||Behavioral: Brief Analogue Functional Analysis Other: No Brief AFA||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|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|
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.
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
- 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).
- 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).
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
|United States, Tennessee|
|Vanderbilt University Medical Center - MEND Clinic|
|Nashville, Tennessee, United States, 37212|
|Principal Investigator:||Kevin Sanders, MD||MEND Clinic - Director|