Evaluation of the feasibility and effectiveness of a health facility-based combined with home-based early childhood development intervention in Siaya County, Kenya: a cluster-randomized control trial


  • Patricia Kitsao-Wekulo Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi http://orcid.org/0000-0003-4206-9746
  • Hermann P. P. Domfouet Data Measurement and Evaluation Unit, African Population and Health Research Center, Nairobi,
  • Silas Onyango Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi
  • Milka Wanjohi Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi
  • Debjeet Sen PATH-US Office, Seattle, WA
  • Matthew Frey PATH-US Office, Seattle, WA
  • Loida Erhard PATH-US Office, Seattle, WA
  • Ranju Baral PATH-US Office, Seattle, WA
  • Christopher Obong'o PATH- Kenya Office, Nairobi
  • Oscar Kadenge PATH- Kenya Office, Nairobi
  • Beatrice Oyugi PATH- Kenya Office, Nairobi
  • Rachel Kavithe PATH- Kenya Office, Nairobi
  • Dickens Omedo PATH- Kenya Office, Nairobi
  • Amina Abubakar Neuroassessment Unit, KEMRI-Wellcome Trust Research Programme, Kilifi
  • Teresa Mwoma Department of Early Childhood Studies, Kenyatta University, Nairobi
  • Stewart Kabaka Newborn, Child and Adolescent Health Unit, Ministry of Health, Nairobi
  • Mark Tomlinson Department of Global Health, Stellenbosch University, Matieland
  • Linda Richter DST-NRF Centre of Excellence in Human Development, The University of the Witwatersrand
  • Cyril Engmann Department of Pediatrics and Department of Global Health, University of Washington, Seattle, WA
  • Elizabeth Kimani-Murage Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi




Early childhood development, Inadequate stimulation, Operational feasibility, Kenya, Health facility-based ECD intervention, Home-based ECD counseling


Background: Approximately 250 million (43%) children under five years in low- and middle-income countries are at risk of sub-optimal development. Of these, 67% are found in sub-Saharan Africa due to exposure to multiple risks, including inadequate stimulation at home. In order to promote early childhood development (ECD), an intervention integrating ECD content into routine facility-based health services and supporting ECD policy and advocacy is currently being implemented in Siaya County. In addition, parental counseling on early stimulation is integrated into home-based visits by community health volunteers. We aim to evaluate the intervention’s operational feasibility, effectiveness and cost-effectiveness.

Methods: The study is a cluster-randomized controlled trial using a mixed-methods approach. The study is being conducted in Bondo sub-county in Siaya County. The study has three arms. Arm 1 will receive a health facility-based ECD intervention. Arm 2 will receive the health facility-based ECD intervention combined with home-based ECD counselling. Arm 3 (control) will receive standard care. Six health facilities in each study arm (18 in total) will be randomly selected from wards within the sub-county. We aim to recruit and follow-up 699 mother/caregiver-child dyads, 233 in each arm. Pregnant women are recruited when they visit health facilities during the third trimester. Analysis will involve estimating the effect of the intervention using mixed linear models and the Difference-in-Differences estimator.

Conclusions: The data generated from this study will provide much-needed information for program design and implementation of interventions aimed at promoting ECD in Kenya and other sub-Saharan African countries.

Trial Registration: Current Control Trial is ISRCTN11561283.


Author Biographies

Patricia Kitsao-Wekulo, Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi

Maternal and Child Wellbeing Unit

Associate Research Scientist

Hermann P. P. Domfouet, Data Measurement and Evaluation Unit, African Population and Health Research Center, Nairobi,

Data Measurement and Evaluation

Associate Research Scientist

Silas Onyango, Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi

Maternal and Child Wellbeing Unit

Research Officer

Milka Wanjohi, Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi

Maternal and Child Wellbeing

Research Officer

Debjeet Sen, PATH-US Office, Seattle, WA

Regional Specialist, Early Childhood Development & Nutrition

Stewart Kabaka, Newborn, Child and Adolescent Health Unit, Ministry of Health, Nairobi


Neonatal, Child and Adolescent Health Unit

Elizabeth Kimani-Murage, Maternal and Child Wellbeing Unit, African Population and Health Research Center, Nairobi

Maternal and Child Wellbeing Unit

Head of Unit


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