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OpenTrials
Completed

NCT Number: NCT03847337

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

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.

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Key information

Age range

15 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telehealth-Screening Tool for Autism in Toddlers (STAT)

Other

Structured autism screening tool

Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)

Other

Semi-structured autism screening tool

Primary outcomes

  1. Accurate Diagnosis of Autism Via Telemedicine

    Time frame: 1 day

    Number of children who are accurately diagnosed with autism via diagnostic evaluation

  2. Accurate Diagnosis of Developmental Delay Via Telemedicine

    Time frame: 1 day

    Number of children who are accurately diagnosed via diagnostic evaluation

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Feb 20, 2019
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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