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Autism Spectrum DisorderNCT05047224

Addressing Disparities in Autism Spectrum Disorder Diagnosis Using a Direct-to-home Telemedicine Tool

A study testing Tele-assessment + in-person assessment and Tele-assessment only in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 42 months
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Tele-assessment + in-person assessment and Tele-assessment only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
664 participants
Where
1 siteUnited States
Study dates
3 Dec 2021to 6 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 42 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Child between 18 and 42 months of age
  • Child and primary caregiver live within a 3-hour driving radius of one of the sites (i.e., VUMC or UC Davis)
  • Age 18 years or older
  • Parent or legal guardian of participating child
  • Has access to technology (e.g., phone, laptop, or tablet with internet connection and audio-visual capabilities) to connect to the tele-assessment platform
  • Sufficient facility with English to participate in the procedures and complete study measures.

Who cannot join

  • Severe sensorimotor impairment that cannot be corrected and would interfere with completion of study activities
  • Medical conditions for which tele-evaluation of ASD symptoms is likely to be inappropriate or complex (i.e., rare genetic syndromes, severe epilepsy, fragile health).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UC Davis MIND Institute

    Sacramento, California, 95817

Other trials in United States

About this study

Official title: Addressing Disparities in ASD Diagnosis Using a Direct-to-home Telemedicine Tool: Evaluation of Diagnostic Accuracy, Psychometric Properties, and Family Engagement

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.

Read the detailed description

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. This study will recruit 360 toddlers (18-42 months of age) across two sites (VUMC and the University of California, Davis). All toddlers will receive in-home telemedicine assessment for ASD using the TAP. This study has two aims. The first aim will randomize participants to receive either (1) telemedicine assessment and an in-person ASD assessment or (2) telemedicine-based assessment only. The investigators will measure diagnostic accuracy of the TAP in comparison to gold standard, in-person ASD assessment. The investigators will also assess test-retest reliability, inter-rater reliability, and the sensitivity, specificity, and positive predictive value of the TAP. In the second aim, all 360 families will be followed over six months to evaluate service access, family engagement, and family perceptions of the diagnostic process.

Being tested
Tele-assessment + in-person assessment, Tele-assessment only
Keywords
autism spectrum disorder, tele-assessment
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-assessment + in-person assessmentBehavioural

    Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.

  • Tele-assessment onlyBehavioural

    Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.

Study groups in NCT05047224
Study groupRoleWhat they receive
Tele-assessment + in-person assessmentExperimentalParticipants 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.
Receives: Behavioral: Tele-assessment + in-person assessment
Tele-assessment onlyActive comparatorParticipants in this group will receive a tele-assessment using the TAP, followed by a second, shorter tele-assessment.
Receives: Behavioral: Tele-assessment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accuracy of the TAP

    The investigators will compare diagnoses made from the tele-assessment using TAP to those from in-person evaluation. We will calculate the percent agreement between diagnoses assigned in each condition.

    Measured: Baseline to completion of in-person autism evaluation, approximately two weeks

  2. Validity of the TAP

    Validity of the TAP will be measured by assessing the psychometric properties of the tool. Estimated performance metrics will include positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity of the TAP.

    Measured: Baseline to completion of in-person autism evaluation, approximately two weeks

Secondary outcomes (4)

  1. Family perceptions of tele-assessment

    Family perceptions of tele-assessment will be measured by the Parent Perceptions of Telemedicine (PPT) survey. The PPT is an 11-question survey. Seven questions are measured on a three-point scale and will provide quantitative data. Each question ranges from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate more positive perceptions of tele-assessment.

    Measured: Baseline

  2. Family satisfaction with diagnostic services

    Family satisfaction with diagnostic services will be measured by the Parent Service Satisfaction (PSS) survey. The PSS is an 7-question survey. Questions are measured on a three-point scale ranging from 1 (not true) to 3 (very true). Possible survey scores can range from 7 to 21. Higher scores indicate higher satisfaction with diagnostic services.

    Measured: Baseline and six-month follow-up

  3. Family empowerment

    Family empowerment will be measured using the Family Empowerment Scale (FES), which asks questions about caregiver self-efficacy related to understanding, navigating, and supporting their child's needs. The FES is an 24-question survey. Questions are measured on a five-point scale ranging from 1 (never) to 5 (very often). Possible survey scores can range from 24 to 120. Higher scores indicate greater self-perceived empowerment.

    Measured: Baseline and six-month follow-up

  4. Child service access and utilization

    Child service access and use will be measured using the Service Access and Utilization (SAU) questionnaire. The questionnaires asks about receipt of Part C early intervention services as well as private therapy services. Caregivers will complete the questionnaire at seven time points (approximately 15, 30, 45, 60, 90, 120, and 180 days following initial evaluation). At each time point, caregivers will endorse service milestones they have reached (e.g., scheduled an evaluation with the Part C service system, created an Individualized Family Service Plan, began services). We will calculate time to each milestone for each participant.

    Measured: Baseline to six-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2021
  2. Study start3 Dec 2021
  3. Primary completion10 Mar 2026
  4. Study completion6 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
664 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05047224
Sponsor's protocol ID
210760
Other IDs
1R01MH127228-01
Status last verified
Aug 2026
First submitted
7 Sep 2021
Last updated
21 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gangi DN, Corona L, Wagner L, Weitlauf A, Warren Z, Ozonoff S. In-home Tele-assessment for Autism in Toddlers: Validity, Reliability, and Caregiver Satisfaction with the TELE-ASD-PEDS. J Dev Behav Pediatr. 2025 Jun 17;46(3):e261-e268. doi: 10.1097/DBP.0000000000001358.

    PubMed 40526421

  • Ozonoff S, Gangi D, Corona L, Foster T, Hill MM, Honaker M, Maqbool S, Ni R, Nicholson A, Parikh C, Stone C, Spitler AK, Swanson A, Vehorn A, Wagner L, Weitlauf A, Warren Z. Measuring Developmental Delays: Comparison of Parent Report and Direct Testing. J Autism Dev Disord. 2025 Dec;55(12):4492-4498. doi: 10.1007/s10803-024-06292-8. Epub 2024 Feb 26.

    PubMed 38407697

Questions about this trial

What is this clinical trial studying?

A study testing Tele-assessment + in-person assessment and Tele-assessment only in people with Autism Spectrum Disorder, run by Vanderbilt University Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy of the TAP (time frame: Baseline to completion of in-person autism evaluation, approximately two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05047224, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.

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