Artificial-intelligence-based developmental screening for pre-school children (ages 3-6): a scoping review of deployed tools, clinical validity, equity, and implementation in guidance-center settings.

Background: Early identification of neurodevelopmental conditions during the pre-school years (ages 3-6) is critical for timely intervention, yet traditional questionnaire-based screeners suffer from low positive predictive value, late detection, and inequitable access. Artificial intelligence (AI) and machine-learning (ML) methods promise more objective, scalable identification, and two devices (Cognoa Canvas Dx, 2021; EarliPoint Evaluation, 2023) are already US Food and Drug Administration (FDA)-authorized. Recent reviews summarize the technical literature, but few address how deployed tools perform on clinical validity, equity, and real-world implementation, particularly outside high-income, English-speaking settings. Methods: Following Joanna Briggs Institute methodology and the PRISMA extension for scoping reviews (PRISMA-ScR), we searched seven databases (1 January 2020-15 June 2026) and charted primary validation studies of AI/ML developmental-screening tools for children aged 72 months or younger. We mapped tools by modality, diagnostic performance, regulatory status, geographic origin, and, as a structured analytic axis, demographic subgroup (equity) reporting and deployment readiness. Results: Sixteen primary AI-tool studies met inclusion, spanning eight modality classes (eye-tracking, multimodal questionnaire-plus-video, computer-vision home/clinical video, tablet/smartphone digital phenotyping, voice/acoustic ML, electronic-health-record risk prediction, questionnaire-based ML, and wearable sensors) and eight countries (USA, South Korea, Australia, Switzerland, France, Israel, China, Vietnam). Reported sensitivities ranged from approximately 75 to 99.2% and specificities from 78.9 to 95.5%. Only one tool demonstrated stable performance across sex, race, and ethnicity; subgroup-stratified validation was otherwise near-absent. No CE-marked autism-specific screening device was identified. Conclusions: The evidence base has broadened in modality and geography but remains autism-concentrated and equity-blind, with a wide gap between analytic accuracy and primary-care deployment. We propose equity validation, deployment-readiness reporting, and an implementation pathway for low-resource guidance-center settings as priorities.