Effect of the Sit Down and Play Intervention on Neurodevelopment in Infant Visiting Well Baby Clinic using Global Scales for Early Development: A Randomized Controlled Trial

Title: Effect of the Sit Down and Play Intervention on Neurodevelopment in Infants Visiting Well Baby Clinic using Global Scales for Early Development: A Randomized Controlled Trial

Background & Rationale: Infancy is a sensitive period for rapid brain growth, influencing motor, cognitive, and socio-emotional development. Early stimulation, particularly through caregiver-infant play, fosters neural connections and developmental skills. Well-baby clinics provide a unique opportunity to integrate structured developmental interventions alongside routine health checks. The Sit Down and Play (SDP) program, involving guided, interactive play with age-appropriate toys, has shown feasibility and acceptability in enhancing parent-child interactions and early developmental outcomes in both international and Indian contexts. However, limited evidence exists on its direct impact within Indian well-baby clinic settings using standardized, globally comparable tools.

Objective: To evaluate and compare the effect of the SDP intervention on neurodevelopment in infants aged 6–14 weeks attending a well-baby clinic, using the WHO-validated Global Scales for Early Development (GSED).

Methods: This single-blinded, parallel-group randomized controlled trial will recruit 36 healthy infants (18 per group) at 6 ± 1 weeks of corrected age from a tertiary care well-baby clinic in Belagavi, India. Participants will be randomized via concealed opaque envelopes to an experimental (SDP) or control (standard care) group. The SDP group will receive three structured play sessions at 6, 10, and 14 weeks using age-appropriate toys (rattle, ring, mirror), with caregiver demonstration, supervised practice, and daily home-play encouragement. The control group will receive standard developmental guidance without toys or structured play. Neurodevelopment will be assessed at baseline and at 14 weeks using GSED Short Form (caregiver report) and Long Form (direct assessment) covering motor, language, cognitive, and socio-emotional domains.

Outcome Measures: Primary outcome – Change in GSED D-score from baseline to 14 weeks. Secondary outcomes – Parent-reported frequency of play, quality of parent-infant interaction.

Statistical Analysis: Data will be analyzed using paired and independent t-tests (or non-parametric equivalents), with p<0.05 considered significant.

Expected Impact: This study will generate evidence on the effectiveness of integrating low-cost, structured play interventions into routine infant care in India. Positive findings could support policy recommendations for embedding SDP into well-baby clinic protocols to promote early childhood development, especially in resource-limited settings.