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, Hermann P. P. Domfouet, Silas Onyango, Milka Wanjohi, Debjeet Sen, Matthew Frey, Loida Erhard, Ranju Baral, Christopher Obong'o, Oscar Kadenge, Beatrice Oyugi, Rachel Kavithe, Dickens Omedo, Amina Abubakar, Teresa Mwoma, Stewart Kabaka, Mark Tomlinson, Linda Richter, Cyril Engmann, Elizabeth Kimani-Murage

Abstract

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.

 

Keywords

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

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References

Dua T, Tomlinson M, Tablante E, Britto P, Yousfzai A, Daelmans B, et al. Global research priorities to accelerate early child development in the sustainable development era. The Lancet Global Health. 2016;4:e887-9.

Black MM, Walker SP, Fernald LCH, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: science through the life course. The Lancet. 2017;389(10064):77-90.

Global Research on Developmental Disabilities Collaborators. Developmental disabilities among children younger than 5 years in 195 countries and territories, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Global Health. 2018;6:e1100-21.

Walker SP, Powell CA, Grantham-McGregor SM, Himes JH, Chang SM. Nutritional supplementation, psychosocial stimulation, and growth of stunted children: The Jamaican study. Am J Clin Nutr. 1991;54(4):642-8.

Britto PR, Lye SJ, Proulx K, Yousafzai AK, Matthews SG, Vaivada T, et al. Nurturing care: promoting early childhood development. The Lancet. 2017; 389(10064):91-102.

Walker SP, Wachs TD, Gardner JM, Lozoff B, Wasserman GA, Pollitt E, et al. Child development: risk factors for adverse outcomes in developing countries. The Lancet. 2007;369(9556):145-57.

Engle PL, Menon P, Haddad L. Care and nutrition: concepts and measurement. World Development. 1999;27(8):1309-37.

Engle PL, Fernald LCH, Alderman H, Behrman J, O'Gara C, Yousafzai A, et al. Strategies for reducing inequalities and improving developmental outcomes for young children in low-income and middle-income countries. The Lancet. 2011;378(9799):1339-53.

World Health Organization UNCsF, World Bank Group. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. Geneva: World Health Organization; 2018.

Chang SM, Grantham-McGregor SM, Powell CA, Vera-Hernández M, Lopez-Boo F, Baker-Henningham H, et al. Integrating a Parenting Intervention With Routine Primary Health Care: A Cluster Randomized Trial. Pediatrics. 2015;136(2):272-80.

Slemming W, Saloojee H. Beyond survival: The role of health care in promoting ECD. 2013.

Ertem IO, Atay G, Bingoler BE, Dogan DG, Bayhan A, Sarica D. Promoting Child Development at Sick-Child Visits: A Controlled Trial. Pediatrics. 2006;118(1):e124-31.

Yousafzai AK, Rasheed MA, Rizvi A, Armstrong R, Bhutta ZA. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health. The Lancet. 2014;384(9950):1282-93.

Grantham‐McGregor SM, Fernald LCH, Kagawa RMC, Walker SP. Effects of integrated child development and nutritioninterventions on child development and nutritional status. Ann New York Acad Sci. 2014;1308:11-32.

Powell C, Baker-Henningham H, Walker S, Gernay J, Grantham-McGregor S. Feasibility of integrating early stimulation into primary care for undernourished Jamaican children: cluster randomised controlled trial. BMJ. 2004;329.

Tomlinson M, Hartley M, le Roux I, Rotheram-Borus MJ. The Philani Mentor Mothers Intervention: Neighbourhood wide impact on child growth in Cape Town’s peri-urban settlements. Vulnerable Child and Youth Studies. 2016;11(3):221-2.

Potterton J, Stewart A, Cooper P, Becker P. The effect of a basic home stimulation programme on thedevelopment of young children infected with HIV. Developmental Med Child Neurol. 2010;52(6):547-51.

Gowani S, Yousafzai AK, Armstrong R, Bhutta ZA. Cost effectiveness of responsive stimulation and nutrition interventions on early child development outcomes in Pakistan. Ann New York Acad Sci. 2014;1308:149-61.

Kenya National Bureau of Statistics. County Report: Siaya County. Nairobi, Kenya: Kenya National Bureau of Statistics; 2015.

Ministry of Health. County Intergrated Development Plan, 2013 to 2017: County of Siaya. 2013.

Kenya National Bureau of Statistics. Siaya County Multiple Indicator Cluster Survey 2011. Nairobi, Kenya: Kenya Naitonal Bureau of Statistics; 2013.

UNICEF. Care for Child Development Package. New York, NY: United Nations Children’s Fund; 2015.

Mukuria AG, Martin SL, Egondi T, Bingham A, Thuita FM. Role of Social Support in Improving Infant Feeding Practices in Western Kenya: A Quasi-Experimental Study. Global Health Sci Pract. 2016;4(1):55-72.

Hemming K, Girling AJ, Sitch AJ, Marsh J, Lilford RJ. Sample size calculations for cluster randomised controlled trials with a fixed number of clusters. BMC Med Res Methodol. 2011;11:102.

Walker PS, Powell C, Chang SM, Henningham HB, McGregor SG, Hernandez MV, et al. Delivering Parenting Interventions through Health Services in the Caribbean: Impact, Acceptability and Costs. 2015.

Holding P, Abubakar A, Obiero E, van de Vijver FJR, editors. Validation of the Infant-Toddler HOME Inventory among households in low income communities at the Kenyan Coast. 19th International Congress of the International Association for Cross-Cultural Psychology; 2011.

Rahman A, Iqbal Z, Roberts C, Husain N. Cluster randomized trial of a parent-based intervention to support early development of children in a low-income country. Child: Care, Health and Development. 2008;35(1):56-62.

Cohen M. Parental attitudes toward child-rearing : toward the development of a new measure Canada: McGill University; 1990.

UNICEF. Study of Parental Knowledge, Attitudes and Practices Related to Early Childhood Development. Suva, Fiji: United Nations Children’s Fund; 2014.

Hsiao C, Richter L, Makusha T, Matafwali B, van Heerden A, Mabaso M. Use of the ages and stages questionnaire adapted for South Africa and Zambia. Child Care Health Development. 2017;43(1):59-66.

Squires J, Bricker DD, Twombly E, Potter L. Ages & Stages Questionnaires: A Parent-Completed Child-Monitoring System (Third Edition). Baltimore, MA: Paul Brookes Publishing Co; 2009.

Cameron AC, Gelbach JB, Miller DL. Bootstrap-Based Improvements for Inference with Clustered Errors. Review of Economics and Statistics. 2008;90(3):414-27.

Lacey A, Luff D. Trent Focus for Research and Development in Primary Health Care: Qualitative Data Analysis. Trent Focus; 2001.

Kagitcibasi C, Sunar D, Bekman S. Long-term effects of early intervention: Turkish low-income mothers and children. J Applied Developmental Psychol. 2001;22(4):333-61.

Armecin G, Behrman JR, Duazo P, Ghuman S, Gultiano S, King EM, et al. Early childhood development through an integrated program: evidence from the Philippines. Washington, DC: The World Bank; 2006. Contract No.: IE2.

Behrman JR, Cheng Y, Todd PE. Evaluating Preschool Programs When Length of Exposure to the Program Varies: A Nonparametric Approach. Rev Economics Statistics. 2004;86(1):108-32.

Richter LM, Daelmans B, Lombardi J, Heymann J, Boo FL, Behrman JR, et al. Investing in the foundation of sustainable development: pathways to scale up for early childhood development. The Lancet. 2017;389(10064):103-18.

Hamadani JD, Nahar B, Huda SN, Tofail F. Integrating early child development programs intohealth and nutrition services in Bangladesh: benefitsand challenges. Ann New York Acad Sci. 2014;1308:192-203.

Sharma R, Gaffey MF, Alderman H, Bassani DG, Bogard K, Darmstadt GL, et al. Prioritizing research for integrated implementation of early childhood development and maternal, newborn, child and adolescent health and nutrition platforms. J Global Health. 2017;7(1).