Culturally Adapted Home-Based Intervention to Improve Child’s Development in Arab Toddlers in Israel: Study Protocol for a Randomized Controlled Trial

<title>Abstract</title> <p> <bold>Background</bold> Arab toddlers in Israel face socioeconomic and cultural barriers that increase their risk for delays in early language and cognitive development. Early childhood is a sensitive period in which timely, culturally appropriate intervention can support foundational skills. However, few interventions are tailored for this population. This study aims to evaluate a home-based, culturally adapted program designed to improve language, communication, and cognitive abilities in Arab toddlers aged 18 to 36 months. <bold>Methods</bold> This block-randomized controlled trial includes two parallel arms: an intervention group receiving eight weekly home-based sessions and an attention-control group receiving parallel health-promotion visits. Families will be recruited through well-baby clinics. Eligible participants are toddlers aged 18 to 36 months who show mild developmental vulnerabilities and whose caregivers consent to participate. A total of 240 children will be allocated (1:1) to either the intervention or control group. The intervention focuses on optimizing the home environment, promoting child engagement, and enhancing parental responsiveness across play, routines, and shared story time. Outcomes will be assessed at baseline and one month post-intervention. Primary outcomes include language and cognitive development measured using standardized developmental assessments. Secondary outcomes include parental concerns about child development. Mixed-effects linear regression models will evaluate intervention effects. <bold>Discussion</bold> This study addresses a major gap in early developmental support for Arab toddlers in Israel. By integrating culturally adapted content with evidence-based responsive caregiving strategies, the intervention aims to provide an accessible and contextually grounded model for improving early developmental outcomes. The findings may inform scalable, community-based approaches for disadvantaged minority populations. <bold>Trial registration</bold> ClinicalTrials.gov: <bold>NCT07233525</bold> . Registered <bold>14 November 2025</bold> . </p>