Culturally adapted home-based intervention to improve child’s development in Arab toddlers in Israel: study protocol for a randomized controlled trial

Arab toddlers in Israel may face structural, socioeconomic, and linguistic barriers to early developmental support, while few culturally adapted early interventions have been evaluated in this population. This trial aims to determine whether a culturally adapted, home-based parent-implemented intervention improves broad developmental performance and expressive vocabulary in Arab toddlers aged 18–36 months compared with an attention-control programme. This is a two-arm, parallel-group, superiority randomized controlled trial with 1:1 allocation. A total of 240 children will be recruited through approximately 50 Maternal and Child Health Clinics (Tipat Halav) serving Arab communities in northern, central, and southern Israel. Eligible children will be aged 18–36 months, have no significant sensory impairment or severe medical condition, have birth weight ≥ 1500 g, and demonstrate low-average developmental performance, approximately 1–2 standard deviations below the mean, on language or cognitive assessment. Participating caregivers must be willing to complete the eight-session programme and have a Patient Health Questionnaire-9 score < 10. Randomization will be stratified by age group (18–24 vs. 24–36 months) and region (North, Centre, South). Participants and intervention providers cannot be blinded because of the nature of the intervention; outcome assessors will be independent of intervention delivery and blinded to allocation. The intervention comprises eight weekly home-based sessions targeting the home learning environment, child engagement, and caregiver responsiveness during play, daily routines, and shared story time. The attention-control group will receive eight parallel home-based sessions addressing general child health topics without direct language or cognitive stimulation. Outcomes will be assessed at baseline and 1 month after the final session. The two primary outcomes are the Clinical Adaptive Test/Clinical Linguistic and Auditory Milestone Scale (CAT-CLAMS) Full-Scale Developmental Quotient (FSDQ) and expressive vocabulary measured using the 100-item Arabic Short Form MacArthur-Bates Communicative Development Inventory (CDI). Secondary outcomes include CAT and CLAMS Developmental Quotients, receptive vocabulary, and parent-reported developmental concerns. Primary outcomes will be analyzed in separate baseline-adjusted analysis of covariance (ANCOVA) models, with adjustment for age stratum and region; multiplicity across the two primary outcomes will be controlled using the Holm procedure. No serious intervention-related harms are anticipated; adverse events or safeguarding concerns identified during study activities will be documented and managed according to study procedures. This trial will evaluate a culturally and linguistically adapted home-based developmental intervention for Arab toddlers in Israel. The findings may inform the design and delivery of accessible parent-implemented early developmental programmes in similar community settings. ClinicalTrials.gov, NCT07233525. Registered on 14 November 2025. Trial record: https://clinicaltrials.gov/study/NCT07233525 . First planned enrolment: 20 November 2025.