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

Not Applicable

Completed

• Conditions: Developmental Delay; Autism Spectrum Disorder
• Interventions: Other: Telehealth-Screening Tool for Autism in Toddlers (STAT); Other: Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)

• Registration Number: NCT03847337
• Lead Sponsor: 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.

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-20
• Study Start: 2019-03-04
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-10
• Results First Submitted: 2022-10-31
• Results First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Results First Posted: 2022-11-29
• Last Update Posted: 2022-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

Inclusion Criteria

• Children who have been diagnosed with autism or developmental delay

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Previously diagnosed	Telehealth-Screening Tool for Autism in Toddlers (STAT)	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).
New to diagnosis	Telehealth-Screening Tool for Autism in Toddlers (STAT)	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).
New to diagnosis	Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)	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).
Previously diagnosed	Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)	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).

Primary Outcome Measures

Name	Time	Method
Accurate Diagnosis of Autism Via Telemedicine	1 day	Number of children who are accurately diagnosed with autism via diagnostic evaluation
Accurate Diagnosis of Developmental Delay Via Telemedicine	1 day	Number of children who are accurately diagnosed via diagnostic evaluation

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States