Tele-assessment + In-person assessment for Autism Spectrum Disorders

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Autism Spectrum Disorders+2 More
Tele-assessment + In-person assessment - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Families seeking evaluation for autism spectrum disorder (ASD) often face barriers such as low availability of specialists, lengthy waitlists, and long distances to tertiary care diagnostic centers. This is especially true for children from traditionally underserved groups and communities. Without innovative approaches for enhanced identification of ASD, families and clinicians will continue to struggle with accessing and providing care. Telemedicine offers tremendous potential for addressing this need, but there are few psychometrically sound, validated tools that can be administered remotely, via telehealth platforms. This team of investigators developed and conducted a preliminary evaluation of a novel parent-administered, clinician-guided tele-diagnostic tool, the TAP (TELE-ASD-PEDS), designed specifically for direct-to-home and community clinic use with toddlers. Remote administration of the TAP yielded a very high level of agreement with blinded comprehensive evaluation regarding ASD risk classification. Subsequently, the unanticipated broad dissemination of the TAP during COVID-19 demonstrated its value for traditionally underserved groups, spanning broad geographies. Although promising, this work was limited by its specific focus on toddlers with ASD concerns. A telemedicine tool designed for the unique context and population of preschool-aged children referred for diagnostic assessment could have tremendous value in terms of both accurate identification as well as family engagement with service. In the current work, the investigators will now evaluate the performance, usability, and utility of the TAP-Preschool, a new telemedicine tool for ASD risk assessment in preschoolers, through a clinical trial. The TAP-Preschool was developed through a computationally informed co-production in which the targeted population were recruited as active partners in designing the tool. The investigators will gather critical data not only regarding its structure and accuracy, but also its potential deployment across systems responsible for engaging children and families from underserved groups in meaningful service. This work has potential to transform the ASD evaluation process and dramatically improve care access for traditionally underserved groups.

Eligible Conditions
  • Autism Spectrum Disorders
  • Autism Spectrum Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Autism Spectrum Disorders

Study Objectives

7 Primary · 0 Secondary · Reporting Duration: Through study completion, an average of 2 years

NPV will be calculated immediately after the last participant completes their in-person assessment
Negative Predictive Value (NPV) of the TAP-Preschool
PPV will be calculated immediately after the last participant completes their in-person assessment
Positive Predictive Value (PPV) of the TAP-Preschool
Sensitivity will be calculated immediately after the last participant completes their in-person assessment
Sensitivity of the TAP-Preschool
Specificity will be calculated immediately after the last participant completes their in-person assessment
Specificity of the TAP-Preschool
Year 2
Diagnostic Certainty: In-person assessment
Diagnostic Certainty: Tele-assessment
Family Satisfaction

Trial Safety

Safety Progress

1 of 3

Other trials for Autism Spectrum Disorders

Trial Design

1 Treatment Group

Tele-assessment + In-person assessment
1 of 1
Experimental Treatment

150 Total Participants · 1 Treatment Group

Primary Treatment: Tele-assessment + In-person assessment · No Placebo Group · N/A

Tele-assessment + In-person assessment
Behavioral
Experimental Group · 1 Intervention: Tele-assessment + In-person assessment · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 years

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,522 Previous Clinical Trials
1,814,440 Total Patients Enrolled
Vanderbilt University Medical CenterLead Sponsor
768 Previous Clinical Trials
591,964 Total Patients Enrolled
Zachary Warren, PhDPrincipal InvestigatorVanderbilt University Medical Center

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 19th, 2021

Last Reviewed: October 10th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.