Volume 23, Issue 4 (Special Issue 2025)
Nursing and Midwifery Journal 2025, 23(4): 16-24 |
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Ethics code: IR.UMSU.REC.1403.030
Clinical trials code: IRCT20240710062380N1
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tavassoli G, Lotfnezhad Afshar H, Farrokh Eslamlou H, Gozali E, Rahimi B. A Stratified, Assessor-Blinded, Randomized Controlled Trial to Assess the Effectiveness of a Mobile Health (Mhealth) Intervention to Promote Development in Children Under 42 Months of Age: Study Protocol. Nursing and Midwifery Journal 2025; 23 (4) :16-24
URL: http://unmf.umsu.ac.ir/article-1-5473-en.html
URL: http://unmf.umsu.ac.ir/article-1-5473-en.html
Ghanbar Tavassoli1 
, Hadi Lotfnezhad Afshar2 , Hamidreza Farrokh Eslamlou *3 , Elahe Gozali2 , Bahlol Rahimi2
, Hadi Lotfnezhad Afshar2 , Hamidreza Farrokh Eslamlou *3 , Elahe Gozali2 , Bahlol Rahimi2
1- Student Research Committee, Urmia University of Medical Sciences, Urmia, Iran & Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran
2- Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran
3- Reproductive Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran
2- Health and Biomedical Informatics Research Center, Urmia University of Medical Sciences, Urmia, Iran
3- Reproductive Health Research Center, Clinical Research Institute, Urmia University of Medical Sciences, Urmia, Iran
Abstract: (176 Views)
Background: 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’ knowledge, attitudes, and practices.
Methods: 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’ KAP measured by a structured questionnaire. Primary analysis will use ANCOVA. Outcome assessors and data analysts will be blinded.
Expected Results: 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.
Discussion: 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.
Methods: 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’ KAP measured by a structured questionnaire. Primary analysis will use ANCOVA. Outcome assessors and data analysts will be blinded.
Expected Results: 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.
Discussion: 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.
Type of Study: Research |
Subject:
Digital Nursing
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