Telemedicine Assessments for Autism

Overseen By Laura Corona, Ph.D.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Severe sensorimotor impairment, severe epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

720 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate a telemedicine tool called TELE-ASD-PEDS (TAP), which assists in assessing autism symptoms in toddlers. Researchers seek to compare TAP with traditional in-person assessments and determine its effectiveness across diverse families and healthcare providers. Participants may receive both a tele-assessment and an in-person evaluation or only tele-assessments. The trial seeks toddlers aged 18 to 42 months, living within three hours of specific sites, whose parents have access to the necessary technology for tele-assessments. As an unphased study, this trial offers families the chance to contribute to innovative research that could improve autism assessments for diverse communities.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the TELE-ASD-PEDS (TAP) is safe for assessing autism spectrum disorder symptoms in toddlers?

Research has shown that online assessments for autism spectrum disorder (ASD) are safe and well-received. Studies indicate that telehealth tools, such as the TELE-ASD-PEDS (TAP), achieve 80-91% accuracy in diagnosing ASD, demonstrating effectiveness without major safety issues for families.

One study with 144 toddlers found that tele-assessment methods for ASD had a high accuracy rate of 92%, supporting their reliability and safety. Families and healthcare providers have expressed high satisfaction with these online assessments, further confirming their safety and effectiveness.

When combined with in-person evaluations, research suggests that telehealth for ASD assessments is a safe and practical choice. Overall, both online and in-person methods are safe, with no major problems reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using tele-assessment for autism because it offers a flexible and accessible way to evaluate individuals without needing them to travel to a clinic. This approach can save time and reduce stress for families, making it a more convenient option compared to traditional, in-person evaluations. By using tele-assessment, clinicians can reach a wider range of patients, especially those in remote or underserved areas, potentially speeding up the diagnosis process and allowing for earlier intervention. Additionally, the trial is comparing tele-assessment alone and in combination with in-person assessment, which could help determine the most effective and efficient method for diagnosing autism spectrum disorder.

What evidence suggests that the TELE-ASD-PEDS is effective for assessing autism?

Research shows that tools like the TELE-ASD-PEDS (TAP) effectively check autism symptoms in children. Studies have found that tele-assessment results closely match those from traditional in-person evaluations, proving their reliability. For example, one study found that doctors correctly diagnosed autism in 85% of children using tele-assessment methods. The TAP tool diagnosed autism in about 71% of children tested, though some may need further tests. In this trial, participants will receive either a tele-assessment only or a combination of tele-assessment and in-person assessment. These findings suggest that tele-assessments can serve as a dependable alternative to in-person assessments for diagnosing autism. ^{1 3 6 7 8}

Who Is on the Research Team?

Zachary Warren, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for parents or guardians of toddlers aged 18-42 months who may have autism. Participants must be over 18, speak English well enough to follow the study procedures, live within a 3-hour drive from the study sites, and have access to technology with internet and audio-visual capabilities for tele-assessment.

Inclusion Criteria

You and your primary caregiver live within a 3-hour drive of one of the study sites (either VUMC or UC Davis).

You can speak and understand English well enough to take part in the study and answer questions.

The parent or legal guardian of a child will be involved in the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tele-assessment

Participants receive an in-home telemedicine assessment for ASD using the TAP

Approximately 2 weeks

1 telemedicine visit

In-person Assessment

Participants in the experimental group attend a traditional, in-person evaluation for autism spectrum disorder

Approximately 2 weeks

1 in-person visit

Follow-up

Participants are monitored for service access, family engagement, and family perceptions of the diagnostic process

6 months

7 follow-up points (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Tele-assessment + in-person assessment
• Tele-assessment only

Trial Overview

The study is testing a telemedicine tool called TELE-ASD-PEDS (TAP) designed for assessing autism symptoms in toddlers at home. It compares the effectiveness of TAP assessments done remotely with traditional in-person evaluations.

How Is the Trial Designed?

Group I: Tele-assessment + in-person assessment Experimental Treatment 1 Intervention

Participants in this group will receive a tele-assessment using the TAP and will attend a traditional, in-person evaluation for autism spectrum disorder in a clinic setting.

Group II: Tele-assessment only Active Control 1 Intervention

Participants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.

Tele-assessment + in-person assessment is already approved in United States for the following indications:

Approved in United States as TELE-ASD-PEDS for:

• Autism Spectrum Disorder (ASD) diagnosis in toddlers

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Telemedicine models for diagnosing and intervening in children with autism spectrum disorder (ASD) have been developed, focusing on both synchronous and asynchronous methods to meet patient needs during the COVID-19 pandemic.

These models aim to provide preliminary assessments and support for families, enhancing parent involvement and improving children's social communication skills, while not replacing in-person evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2 and Later of COVID-19 Lockdown: Is it Possible to Perform Remote Diagnosis and Intervention for Autism Spectrum Disorder? An Online-Mediated Approach. Narzisi, A.[2020]

A tele-assessment procedure for diagnosing autism spectrum disorder (ASD) was successfully implemented for 335 children aged 14-78 months, allowing clinicians to determine an ASD diagnosis for 85% of the participants during the COVID-19 pandemic.

The study found that specific repetitive behaviors were predictive of an ASD diagnosis, and the caregiver-delivered assessment tool (TELE-ASD-PEDS) was effective for children aged 36 months and older with delayed language, highlighting the potential of telemedicine to improve access to diagnostic services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tele-assessment of young children referred for autism spectrum disorder evaluation during COVID-19: Associations among clinical characteristics and diagnostic outcome. McNally Keehn, R., Enneking, B., Ryan, T., et al.[2023]

A clinical trial involving 144 toddlers showed that tele-assessment methods for autism spectrum disorder (ASD) achieved a high diagnostic agreement of 92% when compared to traditional in-person assessments.

Both clinicians and caregivers expressed satisfaction with the tele-assessment process, indicating its acceptability as a viable option for identifying ASD in young children, although further refinement of these methods is suggested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Trial of the Accuracy of Novel Telehealth Instruments for the Assessment of Autism in Toddlers. Corona, LL., Wagner, L., Hooper, M., et al.[2023]

The COVID-19 pandemic has led to an increased acceptance of telemedicine for assessing young children at risk for autism spectrum disorder (ASD), with diagnostic providers reporting positive experiences with this method.

The TELE-ASD-PEDS tool was utilized across seven sites, demonstrating clinical acceptability and diagnostic utility for ASD tele-assessment, indicating its potential for future use in practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitioning to Telemedicine During COVID-19: Impact on Perceptions and Use of Telemedicine Procedures for the Diagnosis of Autism in Toddlers. Wagner, L., Weitlauf, AS., Hine, J., et al.[2022]

Younger children receiving educational services for autism spectrum disorder (ASD) may benefit more from virtual assessments, while older patients with psychiatric histories may require in-person evaluations for better diagnostic clarity.

The study indicates that specific patient characteristics, such as age and family history of ASD, can help determine the most suitable assessment method (virtual vs. in-person) for effective diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Patient Characteristics to Understand Which Children May Receive Diagnostic Clarity in a Virtual Autism Spectrum Disorder Evaluation. Phelps, RA., Sample, E., Greene, RK., et al.[2022]

The study introduces a caregiver-mediated tele-assessment model for autism spectrum disorder (ASD) in young children, developed in response to healthcare disruptions caused by the COVID-19 pandemic.

Preliminary data indicate positive outcomes and provider perceptions regarding the effectiveness of tele-assessments, highlighting its potential as a viable alternative to traditional in-person assessments during times of social distancing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the TELE-ASD-PEDS for Autism Evaluations in Response to COVID-19: Preliminary Outcomes and Clinician Acceptability. Wagner, L., Corona, LL., Weitlauf, AS., et al.[2022]

A telemedicine assessment procedure for diagnosing Autism Spectrum Disorder (ASD) showed preliminary feasibility and accuracy, with 62% of children diagnosed remotely, although 20% of in-person diagnoses were missed by telemedicine.

Families reported high satisfaction with the telemedicine process, indicating its acceptability, but clinicians expressed uncertainty in 13% of cases, highlighting areas for improvement in diagnostic confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Identification of ASD Through Telemedicine: Potential Value for Underserved Populations. Juárez, AP., Weitlauf, AS., Nicholson, A., et al.[2019]

Telemedicine shows promise as an effective alternative for screening and diagnosing Autism Spectrum Disorder (ASD), potentially reducing the long wait times parents currently face for assessments.

A systematic review of 26 studies revealed that telemedicine applications for ASD had varying sensitivity (0.70 to 1) and specificity (0.38 to 1), indicating that while some tools are effective, more rigorous studies with larger sample sizes are needed to fully evaluate their reliability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth screening, assessment, and diagnosis of autism spectrum disorder. Liu, M., Ma, Z.[2022]

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Studies have shown that telehealth methods used in virtual autism assessments are between 80-91% accurate in diagnosing autism spectrum disorder ...