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

NCT ID: NCT03847337

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2021-09-30

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)

Conditions

Autism Spectrum Disorder; Developmental Delay

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Telehealth-Screening Tool for Autism in Toddlers (STAT)

Intervention Type: OTHER

Structured autism screening tool

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

Intervention Type: OTHER

Semi-structured autism screening tool

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).

Group Type: EXPERIMENTAL

Telehealth-Screening Tool for Autism in Toddlers (STAT)

Intervention Type: OTHER

Structured autism screening tool

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

Intervention Type: OTHER

Semi-structured autism screening tool

Interventions

Telehealth-Screening Tool for Autism in Toddlers (STAT)

Structured autism screening tool

Intervention Type: OTHER

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

Semi-structured autism screening tool

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 15 Months
• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zachary Warren

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zachary E Warren, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R21MH118539-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

190152

Identifier Type: -

Identifier Source: org_study_id