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Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism

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ClinicalTrials.gov Identifier: NCT03847337
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : April 25, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Zachary Warren, Vanderbilt University Medical Center

Brief Summary:
In this study, the investigators are trying to find new ways to screen for autism spectrum disorder (ASD) in young children. The investigators want to see if people like pediatricians can screen children for ASD while a psychologist watches on a monitor. The investigators are testing two screening tools. The investigators want to see if they are good at identifying children with ASD and children without ASD. The investigators hope this research will make it easier for families to get answers when there are concerns for ASD.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Developmental Delay Other: Telehealth-Screening Tool for Autism in Toddlers (STAT) Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS) Not Applicable

Detailed Description:
The investigators will evaluate and compare two telemedicine assessment tools (TELE-STAT and TELE-ASD-PEDS) that could allow parents or naive providers in remote locations to complete an Autism Spectrum Disorder (ASD) risk assessment via telemedicine consultation via an expert psychologist. These tools will be low cost, compliant with privacy rules, easily deployed in community practice settings, and explicitly designed to work within paradigms that may be pragmatically and financially viable for systems of care housing remote clinicians. These telemedicine tools could provide methodologies wherein children could be rapidly linked to and appropriately assessed by ASD experts within practice locations where the children are currently receiving care. In turn, these children, who without such assessment may wait months or over a year in many circumstances to access assessments and interventions, may be able to receive appropriate ASD assessments within days or weeks of screening/surveillance concerns within practice settings where the children are already accessing and familiar with (i.e., minimizing loss to referral and follow-up)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Can Novel Telemedicine Tools Reduce Disparities Related to Early Identification of Autism
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: New to diagnosis
We will test two telemedicine tools with children who have not been previously diagnosed with autism or developmental delay. The two telemedicine tools are the Screening Tool for Autism in Toddlers (TELE-STAT) and the Autism Spectrum Disorder (ASD-PEDS).
Other: Telehealth-Screening Tool for Autism in Toddlers (STAT)
Structured autism screening tool

Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Semi-structured autism screening tool

Experimental: Previously diagnosed
We will test two telemedicine tools with children who have been previously diagnosed with autism or developmental delay. The two telemedicine tools are the Screening Tool for Autism in Toddlers (TELE-STAT) and the Autism Spectrum Disorder (ASD-PEDS).
Other: Telehealth-Screening Tool for Autism in Toddlers (STAT)
Structured autism screening tool

Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Semi-structured autism screening tool




Primary Outcome Measures :
  1. Accurate diagnosis of autism via telemedicine [ Time Frame: 1 day ]
    Number of children who are accurately diagnosed with autism as verified by medical record

  2. Accurate diagnosis of developmental delay via telemedicine [ Time Frame: 1 day ]
    Number of children who are accurately diagnosed via diagnostic evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who have been diagnosed with autism or developmental delay

Exclusion Criteria:

  • Children with genetic disorders
  • Children with medical complexities, such as blindness or deafness
  • Children whose families do not speak English

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): NCT03847337


Contacts
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Contact: Amy G Nicholson, MA 6153438748 amy.g.nicholson@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Sponsors and Collaborators
Vanderbilt University Medical Center
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Zachary E Warren, PhD Vanderbilt University Medical Center

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Responsible Party: Zachary Warren, Associate Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03847337     History of Changes
Other Study ID Numbers: 190152
1R21MH118539-01 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zachary Warren, Vanderbilt University Medical Center:
telemedicine

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders