Trial Outcomes & Findings for Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool Children With Autism? (NCT NCT05373173)

Last Updated: 2025-08-24

Results Overview

Clinicians rated diagnostic certainty on a 4-point Likert Scale. Possible scores range from 1 to 4, with 1 indicating "Completely Uncertain," 2 indicating "Somewhat Uncertain," 3 indicating "Somewhat Certain" and 4 indicating "Completely Certain." Higher values reflect stronger clinician diagnostic certainty.

Recruitment status

COMPLETED

Study phase

Target enrollment

148 participants

Primary outcome timeframe

Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

Results posted on

2025-08-24

Participant Flow

Children were recruited together with a participating primary caregiver (i.e., parent-child dyads). Study sample size below and throughout results is reflective of parent-child dyads.

Participant milestones

Participant milestones
Measure	Tele-assessment Only Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills).	Tele-assessment + In-person Assessment Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All dyads will participate in an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.
Overall Study STARTED	30	118
Overall Study COMPLETED	30	116
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was not collected for parent participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tele-assessment Only - Children n=30 Participants Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment - Children n=118 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.	Tele-assessment Only - Parents n=30 Participants Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment - Parents n=118 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.	Total n=296 Participants Total of all reporting groups
Age, Continuous	49.3 months STANDARD_DEVIATION 9 • n=30 Participants • Age was not collected for parent participants	47.8 months STANDARD_DEVIATION 9.9 • n=118 Participants • Age was not collected for parent participants	—	—	47.82 months STANDARD_DEVIATION 9.73 • n=148 Participants • Age was not collected for parent participants
Sex: Female, Male Female	7 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	33 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	—	102 Participants n=114 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	142 Participants n=262 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.
Sex: Female, Male Male	23 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	85 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	—	12 Participants n=114 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.	120 Participants n=262 Participants • Baseline characteristics were not collected for parent participants in the Tele-assessment only arm. 4 parents in the tele-assessment + in-person arm opted not to report their gender.
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	10 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	—	7 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	26 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	105 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	—	105 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	231 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	3 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	—	6 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.	9 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 6 parents in the tele-assessment + in-person arm opted not to provide information about their ethnicity.
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	0 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	0 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	0 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) Asian	1 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	4 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	6 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	11 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	0 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	0 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	0 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) Black or African American	5 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	23 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	21 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	49 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) White	23 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	70 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	80 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	173 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) More than one race	1 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	15 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	3 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	19 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=30 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	6 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	—	8 Participants n=118 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.	14 Participants n=266 Participants • Baseline characteristics were not collected for parent participants in the tele-assessment only arm. 8 parents in the tele-assessment + in-person arm opted not to provide information about their race.
Region of Enrollment United States	30 participants n=30 Participants	118 participants n=118 Participants	30 participants n=30 Participants	118 participants n=118 Participants	296 participants n=296 Participants

PRIMARY outcome

Timeframe: Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

Population: Diagnostic certainty is analyzed for child participants only.

Outcome measures

Outcome measures
Measure	Tele-assessment Only n=30 Participants Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment n=116 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.
Diagnostic Certainty: Tele-assessment	3.07 score on a scale (range 1-4) Standard Deviation 0.83	2.85 score on a scale (range 1-4) Standard Deviation 0.99

PRIMARY outcome

Timeframe: Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes

Population: In the tele-assessment only group, 27/30 participating parents completed the post-telehealth visit satisfaction survey. In the tele-assessment + in-person assessment group, 114/118 participating parents completed the post-telehealth visit satisfaction survey. Only parents completed satisfaction surveys.

Parents will complete the Parent Perceptions of Telehealth survey to assess perceptions of tele-assessment procedures. The survey includes seven questions with three response options per questions (Very True, Somewhat True, Not True). The percentage of parents endorsing "very true" is reported.

Outcome measures

Outcome measures
Measure	Tele-assessment Only n=27 Participants Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment n=114 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.
Family Satisfaction I felt comfortable receiving feedback about my child over telehealth.	92.6 percentage endorsing "very true"	95.6 percentage endorsing "very true"
Family Satisfaction Before I started my child's telehealth visit, I understood what I would be doing.	96.3 percentage endorsing "very true"	93.0 percentage endorsing "very true"
Family Satisfaction The instructions the psychologist gave me abouthow to play with my child were easy to follow.	96.3 percentage endorsing "very true"	98.2 percentage endorsing "very true"
Family Satisfaction The activities got my child to show the behaviors I am concerned about.	38.5 percentage endorsing "very true"	51.8 percentage endorsing "very true"
Family Satisfaction The telehealth visit lasted the right amount of time.	77.8 percentage endorsing "very true"	91.2 percentage endorsing "very true"
Family Satisfaction I would recommend participating in this kind of telehealth evaluation to others.	81.5 percentage endorsing "very true"	90.4 percentage endorsing "very true"
Family Satisfaction The telehealth technology was easy to use.	100 percentage endorsing "very true"	91.9 percentage endorsing "very true"

PRIMARY outcome

Timeframe: Single timepoint: Immediately after completing tele-assessment, an average of 180 minutes

Population: Participants in the Tele-assessment only arm did not receive in-person assessment. Diagnostic certainty is analyzed for child participants only.

Outcome measures

Outcome measures
Measure	Tele-assessment Only Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment n=116 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.
Diagnostic Certainty: In-person Assessment	—	3.64 score on a scale (range 1-4) Standard Deviation 0.67

PRIMARY outcome

Timeframe: Single timepoint: Calculated immediately after completion of in-person assessment

Population: Diagnostic accuracy is calculated for child participants only.

For the preliminary tele-assessment only arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the child's existing diagnosis (autism vs not autism). For the tele-assessment + in-person assessment arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the diagnostic determination following in-person assessment (autism vs not autism).

Outcome measures

Outcome measures
Measure	Tele-assessment Only n=30 Participants Each parent-child dyad will complete a tele-assessment only. Consented dyads will complete home-based tele-assessment via Zoom that includes the TAP-Preschool. Each participant will have recent data available from comprehensive evaluation tools (ADOS-2, cognitive functioning, adaptive skills). After the session, participating caregivers will provide information about acceptability and challenges.	Tele-assessment + In-person Assessment n=116 Participants Each parent-child dyad will receive an in-person tele-assessment appointment and an in-person evaluation. All consented dyads will complete an initial home-based tele-assessment visit via Zoom that includes the TAP-Preschool and a brief symptom-focused developmental interview with a consented clinician. The initial tele-assessment session includes interviewing and developmental assessment to mimic real-world use of TAP-Preschool. After the session, the examiner will record the clinical diagnosis issued (ASD, other developmental concerns, or typical development) and complete two diagnostic certainty ratings. All initial TAP-Preschool administrations will be recorded via Zoom, and 50% of administrations (randomly selected) will be co-scored by a blinded examiner, unaware of prior assessment results and diagnostic decision, to evaluate inter-rater reliability. Within 7 days of the remote assessment, dyads will participate in an in-person diagnostic assessment including common comprehensive measures of ASD, cognitive skills, and adaptive behavior.
Diagnostic Accuracy of TAP-P	60 percentage of participants	81.9 percentage of participants

Adverse Events

Tele-assessment Only - Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tele-assessment + In-person Assessment - Children

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tele-assessment Only - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tele-assessment + In-person Assessment - Parents

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zachary Warren, Ph.D.

Vanderbilt University Medical Center

Phone: 615-875-3085

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place