Recruiting

TAP-Preschool

Sponsor:

Vanderbilt University Medical Center

Code:

NCT07932665

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Interventions

Tele-assessment using the TAP-P

Study Details

Brief summary:

Use of tele-assessment for evaluation and diagnosis of autism in toddlers has demonstrated success in increasing service access and reducing clinical wait times, with high levels of diagnostic accuracy, clinician confidence, and family satisfaction; however, these models have not yet been rigorously evaluated within the preschool age range. The TAP-Preschool (TAP-P) was developed by the investigative team for tele-assessment of autism in preschool-aged children, with preliminary studies demonstrating utility with many children with limited verbal language and some children with more flexible verbal language. The proposed study will recruit a larger sample of children with varied language and phenotypic profiles to (1) thoroughly evaluate the psychometric properties of the TAP-P and (2) investigate child and family factors associated with diagnostic ascertainment and family satisfaction with tele-assessment to inform the creation of a decision support tool intended to recommend families for either tele- or in-person assessment, with the ultimate goal of optimizing clinical care models to serve patients in efficient ways while routing families to diagnostic care pathways that best fit their needs.

Conditions

Autism

Study ID

NCT07932665

Start date

Oct 4, 2026

Status verified date

Nov, 2026

Completion date

Apr 30, 2031

Anticipated

Primary completion date

Apr 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children 36-72 months of age;
  • Participation of a primary caregiver who can speak and understand English sufficiently to complete questionnaires and interviews;
  • Primary caregiver access to the technology required for tele assessment (e.g., smartphone, tablet, or computer with internet connection and audio/video capabilities);
  • Ability to travel to VUMC for the in-person diagnostic assessment;
  • Referral for questions related to autism, developmental delay, or developmental concerns, or have no identified concerns (to ensure phenotypic variability).

Exclusion Criteria:

  • Severe, non-corrected sensory or motor impairments (e.g., profound hearing or vision impairment, inability to ambulate) that would prevent completion of study procedures;
  • Medical or genetic conditions for which tele-assessment is inappropriate or insufficient (e.g., rare genetic syndromes, severe epilepsy, fragile medical stability)
  • Presentation with conditions requiring alternative assessment pathways incompatible with the study protocol.

Study Design

Enrollment

250 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Tele-assessment using the TAP-P

Participants will complete a tele-assessment that includes administration of the TAP-P, developmental assessment using the Developmental Profile 4 (DP-4), and clinical interview focused on characteristics of autism. Tele-assessments will be completed via HIPAA-compliant Zoom by licensed clinical psychological providers with expertise in autism assessment. The tele-assessment appointment, which will be timed, is estimated to take 90-150 minutes. Diagnostic feedback will not be provided following tele-assessment, as all participants will complete in-person assessment to determine diagnostic outcome.

Interventions

Tele-assessment using the TAP-P

The TAP-P was developed specifically for telemedicine-based autism assessment of preschool-aged children. It has distinct administration and scoring procedures for children with less verbal language (TAP-P Form 1) and those with more verbal language (TAP-P Form 2). All children first complete an initial set of clinician-guided, caregiver-mediated activities, including independent play, interactive play with caregiver, turn-taking, and bids for social responding. TAP-P Form 1 procedures include activities that elicit a child's social play, requesting strategies, and response to caregiver interference in play. TAP-P Form 2 procedures include additional caregiver-mediated activities (i.e., caregiver-led play) and clinician-mediated activities (i.e., drawing and show-and-tell activities; prompts for conversation). Following TAP-P administration, clinicians score observed child behaviors associated with possible autism.

Primary outcome measure

  • Rate of diagnostic agreement between tele-assessment and clinical best estimate in-person assessment [ Time Frame: Immediately following in-person diagnostic evaluation ]

Central Contacts and Locations

Central contacts

Laura Corona

615-936-5777Laura.L.Corona@vumc.org

Amy Swanson

amy.r.swanson@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Laura Corona

615-936-5777Laura.L.Corona@vumc.org

Amy Swanson

amy.r.swanson@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Nov 12, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-13. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-11-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.