R01HD100984

An Individualized Approach to Promote Nurturing Care in Low and Middle-Income Countries: A Hybrid Effectiveness/Implementation Trial of the International Guide for Monitoring Child Development - Project Summary

More than 40% of children under 5 years in low- and middle-income countries (LMICs) are at risk of not reaching their developmental potential. One of the most effective and proven strategies for supporting early child development in these settings is to empower caregivers and communities to support their children's development. However, evidence on the effectiveness and the barriers and facilitators to implementation of interventions to promote this nurturing care are needed.

In this study, we will use an implementation science framework to evaluate an individualized intervention to promote nurturing care - the International Guide for Monitoring Child Development (GMCD), in rural India and Guatemala. We will conduct a hybrid effectiveness/implementation cluster randomized trial, where children aged 0-2 years will receive individualized visits from frontline health workers administering the GMCD.

The study will have three parts:

Part 1: We will randomize clusters to receive either the GMCD or usual care for 12 months. After 12 months, control clusters will cross-in and all children will receive an additional 12 months of intervention. We will assess the impact of the intervention at 12 and 24 months on developmental outcomes and on the home care environment.

Part 2: We will use the RE-AIM implementation science framework to assess the reach, effectiveness, adoption, implementation, and maintenance of the intervention. We will also use the CFIR (Consolidated Framework for Implementation Research) framework to conduct in-depth complementary qualitative evaluation of implementation barriers and facilitators in high- and low-performing clusters from Part 1.

Part 3: We will assess the cost effectiveness of the intervention.

In conclusion, the study will answer three important questions:
1) Is the GMCD effective at improving developmental outcomes and the home care environment for children at risk in rural India and Guatemala?
2) What real-world institutional and contextual factors influence the impact of the intervention and might affect its potential ability to sustainably reach children and families?
3) Is the intervention cost-effective?

The project will generate globally relevant evidence on community-based early child development interventions in LMICs.

Brigham & Womens Hospital

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Boston, Massachusetts 021156110 United States

Single Zip Code

Global Brain and Nervous System Disorders Research Across the Lifespan (R01 Clinical Trials Optional) (PAR-18-835)

Amendment Since initial award the End Date has been extended from 03/31/26 to 03/31/27 and the total obligations have increased 351% from $557,110 to $2,513,859.