en پرستاری دیجیتال Digital Nursing پژوهشي Research <span style="font-size:11pt"><span style="line-height:150%"><span calibri="" style="font-family:"><strong><span style="background:white"><span segoe="" style="font-family:" ui="">Background: </span></span></strong>Early childhood development profoundly impacts well-being. Mobile health (mHealth) technologies are increasingly integrated into healthcare due to their scalability, affordability, ability to deliver personalized interventions. This paper presents a randomized controlled trial evaluating the effectiveness of a culturally appropriate mobile-based intervention in promoting early childhood development and improving caregivers&rsquo; knowledge, attitudes, and practices.</span></span></span><br> <span style="font-size:11pt"><span style="line-height:150%"><span calibri="" style="font-family:"><strong><span style="background:white"><span segoe="" style="font-family:" ui="">Methods: </span></span></strong>This assessor- and analyst-blinded, stratified RCT evaluates a mHealth intervention for children under 42 months. The intervention is a culturally appropriate mobile-based educational program focusing on cognitive, motor, and language development delivered via a mobile application. We will recruit 110 at-risk caregiver-child pairs (identified by ASQ) from a developmental center in West Azerbaijan, Iran. Participants will be stratified by developmental concern type and randomly assigned (1:1) to intervention or control using a computer-generated, stratified block sequence. The intervention group will receive the mobile program plus standard care; the control group will receive standard care only. Developmental outcomes will be measured using the Bayley scales at baseline and four months. Secondary outcomes include caregivers&rsquo; KAP measured by a structured questionnaire. &nbsp;Primary analysis will use ANCOVA. Outcome assessors and data analysts will be blinded.</span></span></span><br> <span style="font-size:11pt"><span style="line-height:150%"><span calibri="" style="font-family:"><strong><span style="background:white"><span segoe="" style="font-family:" ui="">Expected</span></span></strong> <strong><span style="background:white"><span segoe="" style="font-family:" ui="">Results: </span></span></strong>We predict children in the intervention group will show greater improvements in cognitive, motor, and language domains than controls. Caregivers in the intervention group will show higher KAP scores. Findings will provide evidence supporting adapted mHealth interventions in low-income settings.</span></span></span><br> <span style="font-size:11pt"><span style="line-height:150%"><span calibri="" style="font-family:"><strong><span style="background:white"><span segoe="" style="font-family:" ui="">Discussion: </span></span></strong>This rigorous trial addresses an evidence gap in low- and middle-income settings with limited access to developmental supports. Despite blinding challenges in behavioral interventions, methodological safeguards minimize bias. Results will inform digital health strategies and may serve as a model for integrating mHealth into early childhood care systems in resource-limited settings.</span></span></span><br> &nbsp; Early childhood development, mHealth, Mobile health, Randomized controlled trials 16 24 http://unmf.umsu.ac.ir/browse.php?a_code=A-10-4525-1&slc_lang=en&sid=1 ghanbar tavassoli gh.tavassoli@gmail.com 100319475328460042326 100319475328460042326 No Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran Hadi Lotfnezhad Afshar hadi.afshar@gmail.com 100319475328460042327 100319475328460042327 No Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran Hamidreza Farrokh Eslamlou 100319475328460042328 100319475328460042328 Yes Reproductive Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran Elahe Gozali elahe.gozali@gmail.com 100319475328460042329 100319475328460042329 No Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran Bahlol Rahimi bahlol.rahimi@gmail.com 100319475328460042330 100319475328460042330 No Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran