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

Trial Summary

What is the purpose of this trial?

The investigators propose to evaluate the use of a telemedicine tool, the TELE-ASD-PEDS (TAP), that is designed to assess for autism spectrum disorder (ASD) symptoms in toddlers. The TAP was developed at VUMC by a team of clinical psychologists with expertise in the early identification of ASD. The TAP has been studied in controlled laboratory settings, with high levels of family and clinician satisfaction, as well as excellent agreement with blinded comprehensive ASD evaluation. The TAP has also been used to complete direct-to-home telemedicine assessments during the COVID-19 pandemic. However, the investigators have not yet compared direct-to-home assessments using the TAP with gold standard, in-person ASD assessments. It has also not yet been studied in a diverse sample of families or with providers outside of VUMC. This study will allow the investigators to address those gaps.

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 data supports the effectiveness of the treatment Tele-assessment + in-person assessment, TELE-ASD-PEDS, TAP for autism?

Research shows that tele-assessment, including the TELE-ASD-PEDS tool, can effectively diagnose autism in children, especially those aged 36 months or older with delayed language. During the COVID-19 pandemic, telemedicine allowed clinicians to diagnose autism in 85% of cases, suggesting it can be a reliable alternative to in-person assessments. ^{1 2 3 4 5}

Is telemedicine assessment for autism safe for humans?

The research on telemedicine assessments for autism, such as TELE-ASD-PEDS and TAP, does not report any safety concerns. These assessments have been used successfully to diagnose autism in young children, especially during the COVID-19 pandemic, and families have reported high satisfaction with the process. ^{1 3 4 5 6}

How is the Tele-assessment + in-person assessment treatment for autism different from other treatments?

This treatment is unique because it uses telemedicine to conduct assessments for autism, allowing for remote diagnosis through a novel tool called TELE-ASD-PEDS. This approach is particularly beneficial for families in different locations, providing access to high-quality diagnostic services without the need for in-person visits. ^{2 4 5 7 8}

Research Team

Zachary Warren, Ph.D.

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Identifying Patient Characteristics to Understand Which Children May Receive Diagnostic Clarity in a Virtual Autism Spectrum Disorder Evaluation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A Randomized Trial of the Accuracy of Novel Telehealth Instruments for the Assessment of Autism in Toddlers. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Use of the TELE-ASD-PEDS for Autism Evaluations in Response to COVID-19: Preliminary Outcomes and Clinician Acceptability. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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

5. England 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. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Early Identification of ASD Through Telemedicine: Potential Value for Underserved Populations. [2019]

7. Switzerland 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. [2020]

8. United States 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. [2022]