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Telemedicine Assessment for Autism (TAP-P Trial)

N/A
Recruiting
Led By Zachary Warren, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Novel sample (n = 120): English/Spanish Speaking families with children 36-72 months of age, access to a device capable of supporting Zoom, and has not participated in a diagnostic evaluation
Be younger than 18 years old
Must not have
Initial deployment (n = 30): Severe sensorimotor impairments
Novel sample (n = 120): Severe sensorimotor impairments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trialis developing a telemedicine tool to improve access to ASD diagnosis for underserved groups, such as those with long waitlists or long distances to care.

Who is the study for?
This trial is for preschool children aged 36-72 months who may have autism. It's open to English or Spanish-speaking families with access to a device that supports Zoom. The study includes kids both previously evaluated for autism and those not yet assessed.
What is being tested?
The trial is testing the TAP-Preschool, a new telemedicine tool designed to assess the risk of autism in preschoolers remotely. It compares results from this tool with traditional in-person assessments to see if it can improve care access.
What are the potential side effects?
Since this trial involves assessment tools rather than medication, there are no direct physical side effects expected. However, participating families might experience stress or anxiety related to the use of technology and concerns about their child's development.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I speak English or Spanish, have a child aged 3-6, can use Zoom, and haven't had a diagnostic evaluation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe difficulties in feeling or moving parts of my body.
Select...
I have severe difficulties with movement and sensation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Diagnostic Certainty: In-person assessment
Diagnostic Certainty: Tele-assessment
Family Satisfaction
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Tele-assessment + In-person assessmentExperimental Treatment1 Intervention
All families will receive an in-person tele-assessment appointment and an in-person evaluation.

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
902 Previous Clinical Trials
938,351 Total Patients Enrolled
15 Trials studying Autism Spectrum Disorder
2,283 Patients Enrolled for Autism Spectrum Disorder
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,022 Total Patients Enrolled
84 Trials studying Autism Spectrum Disorder
41,102 Patients Enrolled for Autism Spectrum Disorder
Zachary Warren, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Tele-assessment + In-person assessment Clinical Trial Eligibility Overview. Trial Name: NCT05373173 — N/A
Autism Spectrum Disorder Research Study Groups: Tele-assessment + In-person assessment
Autism Spectrum Disorder Clinical Trial 2023: Tele-assessment + In-person assessment Highlights & Side Effects. Trial Name: NCT05373173 — N/A
Tele-assessment + In-person assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05373173 — N/A
~0 spots leftby Dec 2024