Abstract
BACKGROUND: Children in low- and middle-income countries face obstacles to optimal language and cognitive development due to a variety of factors related to adverse socioeconomic conditions. One of these factors is compromised caregiver-child interactions and associated pressures on parenting. Early development interventions, such as dialogic book-sharing (DBS), address this variable, with evidence from both high-income countries and urban areas of low- and middle-income countries showing that such interventions enhance caregiver-child interaction and the associated benefits for child cognitive and socioemotional development. Yet, evidence for DBS effects is lacking from poor rural communities where the need for such early development intervention may be greatest. OBJECTIVE: The objective of this study is to assess the effects of a DBS intervention, a parenting program for female caregivers of children aged between 15 and 45 months, implemented in rural Tanzania. We aim to assess the impact of the intervention on the following domains: child cognitive and socioemotional skills, parenting and parental stress, and child health. METHODS: The study is a 3-arm cluster randomized controlled trial. In total, 443 female caregivers participated in the study. Clusters of caregivers were randomized to either (1) an index DBS intervention group, (2) a playful activity active control group, or (3) a waitlist control group. The active control group was designed to control for any attention effects, ensuring that observed improvement in the index group can be attributed to the DBS intervention's content. The primary outcomes were child language, parental sensitivity, and parent-child interaction. The secondary outcomes concerned child attention and behavior, parenting practices, and parental stress. A combination of questionnaires and direct observations was applied. Qualitative methods were also used, primarily to capture caregivers' experiences and subjective perspectives on intervention-induced changes. RESULTS: Data collection for the study was completed in September 2024. The study results are expected to be published by late 2025. CONCLUSIONS: This randomized controlled trial of a DBS intervention implemented in rural Tanzania adds to a growing body of international literature exploring the impact and limitations of a simple and scalable early development intervention to enhance child outcomes. TRIAL REGISTRATION: International Standard Registered Clinical/Social Study Number (ISRCTN) ISRCTN12613329; https://www.isrctn.com/ISRCTN12613329. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/68758.