An interventional study of Tele-assessment using the TAP-P in Autism, sponsored by Vanderbilt University Medical Center. Recruiting at 1 site in United States. Open to participants aged 36 Months to 72 Months. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic
Among 603 studies in Autistic Disorder with a site in United States — 123 open to participants now, 152 under way, 3 of them phase 3. Autistic Disorder · United States.
Among the 603 studies in Autistic Disorder with a site in United States, this one is the 31st largest by planned enrollment of the 504 interventional ones that give a count, is one of 47 that started in 2026, is one of 295 with no phase, reaches primary completion later than 144 of the 150 other live ones, and was the 603rd registered.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
Browse Autistic Disorder studies →123 of the 603 studies in Autistic Disorder with a site in United States are open now. Recruiting first, the newest first:
Children's Mercy Hospital Kansas City · Sites in United States
Ages 8–12
University of Wisconsin, Madison · Sites in United States
Massachusetts General Hospital · Sites in United States
Ages 7–17
Stony Brook University · Sites in United States
Ages 12–17
Christopher John McDougle, M.D. · Sites in United States
Ages 18–50 · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 181 Autistic Disorder studies recruiting now, 33 (18%) set no upper age limit and 141 (78%) stop at 75 or younger; 146 take children under 18; 56 take healthy volunteers.
This study: 36 Months to 72 Months · all sexes · no healthy volunteers.
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603 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 55 · Phase 2 122 · Phase 3 43 · Phase 4 18
First in 1997; this study’s year is marked. 47 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 250 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Median enrollment 44 across the 504 interventional studies, 135 across the 96 observational. Of the 408 that completed or were terminated, 143 (35%) have results posted.
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73 of 603 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 835 studies on the registry; 155 are open to participants now.
Of its 126 completed or terminated interventional studies of FDA-regulated products, 92 (73%) have results posted.
Vanderbilt University Medical Center has 7 studies filed under Autistic Disorder — fewer than ten, so there is no comparison to draw.
34 of the studies in Autistic Disorder with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02914951Yale UniversityCognitive-Behavioral Therapy for Irritability in Children With Autism Spectrum Disorder and Intellectual Disability | 2026-12 |
| NCT06627205Stanford UniversitySleep Restriction Therapy (SRT) for Sleep Problems in Children With Autism | 2026-12 |
| NCT04805957Rutgers, The State University of New JerseyValidation Digital Bio-markers During Sulforaphane Treatment. | 2026-12-01 |
| NCT07421830Northeastern UniversityAn Empowering Parent Training Intervention to Increase Physical Activity in Preschool Aged Children With Autism | 2026-12-31 |
| NCT02000284University of ArkansasMitochondrial Dysfunction in Autism Spectrum Disorder | 2026-12-31 |
Add all 34 to your calendar (.ics) → With an account.
Among the 603 studies in Autistic Disorder with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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Exclusion Criteria:
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.
Behavioral: 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.
Rate of diagnostic agreement between tele-assessment and clinical best estimate in-person assessment
Tele-assessment clinicians' diagnostic impressions (i.e., autism vs not autism) will be compared to diagnostic outcome from standard in-person autism evaluation.
Time frame: Immediately following in-person diagnostic evaluation
Plan to share: Yes — Deidentified participant data will be shared in the NIMH Data Archive.
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2031, 54 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 54 months is above that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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