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

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03847337
• Other study ID #: 190152
• Secondary ID: 1R21MH118539-01
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Months to 3 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Developmental Delay

Intervention

Other:
• Telehealth-Screening Tool for Autism in Toddlers (STAT)
Structured autism screening tool
• Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)
Semi-structured autism screening tool

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accurate Diagnosis of Autism Via Telemedicine	Number of children who are accurately diagnosed with autism via diagnostic evaluation	1 day
Primary	Accurate Diagnosis of Developmental Delay Via Telemedicine	Number of children who are accurately diagnosed via diagnostic evaluation	1 day