Autism Spectrum Disorder Clinical Trial
Official title:
Improving Hospitalizations for Children With ASD: Testing the Cost and Clinical Efficacy of Integrated Behavioral Intervention
Verified date | September 2015 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
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: |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center - MEND Clinic | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
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 |
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