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Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial

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Abstract

Integrating an early childhood development (ECD) intervention within routine healthcare visits offers an important opportunity for a population-level approach to support ECD in low- and middle-income countries (LMICs) where 250 million children under the age of 5 years fail to reach their full developmental potential. This paper reports on the feasibility of integrating an adapted healthcare-based ECD intervention (Sit Down and Play) in primary health centers (PHCs) serving low-income rural communities in Karnataka, India, and its potential to support research-informed components needed to improve ECD (e.g., opportunities for learning). Using a prospective cluster nonrandomized pilot and feasibility trial, caregivers with infants 6–10 weeks of age were recruited from 2 PHCs: one which delivered the intervention at two subsequent immunization visits (n = 25) and the other as care as usual (n = 28). Feasibility was assessed using the following indicators: implementation, practicality, acceptability, demand, and limited efficacy. Quality of home stimulation and opportunities for learning were explored with key items from the UNICEF Multiple Cluster Index Surveys with generalized estimating equation models. While outcome measures were to be obtained from all participants 3-month post-enrollment, due to COVID19 restrictions, there was variability in timing of follow-up interviews; however, outcome data from all participants were obtained and no significant group differences existed in contact time. Results suggest the feasibility of delivery of SDP during routine immunization visits, high satisfaction with adapted content, and utility of developed training and fidelity measures. Though not powered for hypothesis testing, our exploratory analyses reveal the intervention group demonstrated greater improvements on quality of home stimulation over time than the control group.

Conclusion: Our findings suggest integrating an ECD intervention with routine healthcare visits is a feasible and promising strategy for supporting ECD in India. Further studies are needed to determine the effectiveness of SDP on children’s development.

Trial registration: ClinicalTrials.gov Identifier: NCT04167254.

What is Known:

• Interventions are increasingly being developed to target responsive caregiving and opportunities for learning because of their potential to support early childhood development (ECD) in low- and middle-income countries where 250 million children under the age of 5 years fail to reach their full developmental potential.

• A critical issue in ECD intervention research is the gap between what is known to be effective treatment to protect healthy brain development and what is provided to millions of caregivers during routine care who live in low-income communities.

What is New:

• We adapted a brief, ECD intervention for use with routine healthcare visits in India as a population-level strategy to support ECD in LMICs.

• Our results demonstrate feasibility, acceptability, and improvements in key parenting behaviors that promote ECD.

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Availability of data and material

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

ASHA:

Accredited social health activists

ECD:

Early childhood development

GEE:

Generalized estimating equation

LMICs:

Low- and middle-income countries

MICS:

Multiple Indicator Cluster Surveys Early Childhood Development Module

PHC:

Primary health center

SDP:

Sit Down and Play

SCT:

Social cognitive theory

UNICEF:

United Nations Children’s Emergency Fund

WHO:

World Health Organization

References

  1. Black MM, Walker SP, Fernald LC et al (2017) Early childhood development coming of age: science through the life course. The Lancet 389:77–90

    Article  Google Scholar 

  2. Lu C, Black MM, Richter LM (2016) Risk of poor development in young children in low-income and middle-income countries: an estimation and analysis at the global, regional, and country level. Lancet Glob Health 4:e916–e922. https://doi.org/10.1016/S2214-109X(16)30266-2

    Article  PubMed  PubMed Central  Google Scholar 

  3. Andrew A, Attanasio O, Augsburg B et al (2020) Effects of a scalable home-visiting intervention on child development in slums of urban India: evidence from a randomised controlled trial. J Child Psychol Psychiatry 61:644–652. https://doi.org/10.1111/jcpp.13171

    Article  PubMed  Google Scholar 

  4. Bhopal S, Roy R, Verma D et al (2019) Impact of adversity on early childhood growth & development in rural India: findings from the early life stress sub-study of the SPRING cluster randomised controlled trial (SPRING-ELS). PLoS ONE 14:e0209122. https://doi.org/10.1371/journal.pone.0209122

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  5. Hermida MJ, Shalom DE, Segretin MS et al (2019) Risks for child cognitive development in rural contexts. Front Psychol. https://doi.org/10.3389/fpsyg.2018.02735

    Article  PubMed  PubMed Central  Google Scholar 

  6. Heckman JJ, Moon SH, Pinto R et al (2010) The rate of return to the HighScope Perry Preschool Program. J Public Econ 94:114–128

    Article  Google Scholar 

  7. Duncan GJ, Dowsett CJ, Claessens A et al (2007) School readiness and later achievement. Dev Psychol 43:1428

    Article  Google Scholar 

  8. Medicine I of (2000) From neurons to neighborhoods: the science of early childhood development. The National Academies Press, Washington, DC

    Google Scholar 

  9. Engle P, Black M (2008) The effect of poverty on child development and educational outcomes. Ann N Y Acad Sci 1136:243–256. https://doi.org/10.1196/annals.1425.023

    Article  PubMed  Google Scholar 

  10. Grantham-McGregor S, Cheung YB, Cueto S et al (2007) Developmental potential in the first 5 years for children in developing countries. The lancet 369:60–70

    Article  Google Scholar 

  11. Noble KG, Engelhardt LE, Brito NH et al (2015) Socioeconomic disparities in neurocognitive development in the first two years of life. Dev Psychobiol 57:535–551. https://doi.org/10.1002/dev.21303

    Article  PubMed  PubMed Central  Google Scholar 

  12. Batalle D, Edwards AD, O’Muircheartaigh J (2018) Annual research review: not just a small adult brain: understanding later neurodevelopment through imaging the neonatal brain. J Child Psychol Psychiatry 59:350–371. https://doi.org/10.1111/jcpp.12838

    Article  PubMed  Google Scholar 

  13. Patel V, Saxena S, Lund C et al (2018) The Lancet Commission on global mental health and sustainable development. The Lancet 392:1553–1598. https://doi.org/10.1016/S0140-6736(18)31612-X

    Article  Google Scholar 

  14. Walker SP, Wachs TD, Grantham-McGregor S et al (2011) Inequality in early childhood: risk and protective factors for early child development. The Lancet 378:1325–1338. https://doi.org/10.1016/S0140-6736(11)60555-2

    Article  Google Scholar 

  15. Bhutta ZA, Guerrant RL, Nelson CA (2017) Neurodevelopment, nutrition, and inflammation: the evolving global child health landscape. Pediatrics 139:S12–S22. https://doi.org/10.1542/peds.2016-2828D

    Article  PubMed  Google Scholar 

  16. Fox SE, Levitt P, Nelson CA (2010) How the timing and quality of early experiences influence the development of brain architecture. Child Dev 81:28–40. https://doi.org/10.1111/j.1467-8624.2009.01380.x

    Article  PubMed  PubMed Central  Google Scholar 

  17. Arora NK, Nair MKC, Gulati S et al (2018) Neurodevelopmental disorders in children aged 2–9 years: population-based burden estimates across five regions in India. PLoS Med 15:e1002615. https://doi.org/10.1371/journal.pmed.1002615

    Article  PubMed  PubMed Central  Google Scholar 

  18. World Health Organization (2015) Health in 2015: from MDGs, Millennium Development Goals to SDGs, Sustainable Development Goals. World Health Organization, Geneva

  19. Improving early childhood development: WHO guideline. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO  https://www.who.int/publications-detail/improving-early-childhood-development-who-guideline. Accessed 1 Apr 2020

  20. Dua T, Tomlinson M, Tablante E et al (2016) Global research priorities to acelerate early child development in the sustainable development era. Lancet Glob Health 4:e887–e889. https://doi.org/10.1016/S2214-109X(16)30218-2

    Article  PubMed  PubMed Central  Google Scholar 

  21. Aboud FE, Yousafzai AK (2015) Global health and development in early childhood. Annu Rev Psychol 66:433–457. https://doi.org/10.1146/annurev-psych-010814-015128

    Article  PubMed  Google Scholar 

  22. Hamadani JD, Mehrin SF, Tofail F et al (2019) Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health 7:e366–e375. https://doi.org/10.1016/S2214-109X(18)30535-7

    Article  PubMed  Google Scholar 

  23. Khan MA, Owais SS, Maqbool S et al (2018) Is integrated private-clinic based early child development care effective? A clustered randomised trial in Pakistan. BJGP Open. https://doi.org/10.3399/bjgpopen18X101593

    Article  PubMed  PubMed Central  Google Scholar 

  24. Chang SM, Grantham-McGregor SM, Powell CA et al (2015) Integrating a parenting intervention with routine primary health care: a cluster randomized trial. Pediatrics 136:272–280. https://doi.org/10.1542/peds.2015-0119

    Article  PubMed  Google Scholar 

  25. Aboud FE, Singla DR, Nahil MI, Borisova I (2013) Effectiveness of a parenting program in Bangladesh to address early childhood health, growth and development. Soc Sci Med 97:250–258. https://doi.org/10.1016/j.socscimed.2013.06.020

    Article  PubMed  Google Scholar 

  26. Yousafzai AK, Aboud FE, Nores M, Kaur R (2018) Reporting guidelines for implementation research on nurturing care interventions designed to promote early childhood development. Ann N Y Acad Sci 1419:26–37. https://doi.org/10.1111/nyas.13648

    Article  PubMed  Google Scholar 

  27. Shah R, DeFrino D, Kim Y, Atkins M (2017) Sit Down and Play: a preventive primary care-based program to enhance parenting practices. J Child Fam Stud 26:540–547. https://doi.org/10.1007/s10826-016-0583-6

    Article  PubMed  Google Scholar 

  28. Shah R, Isaia A, Schwartz A, Atkins M (2019) Encouraging parenting behaviors that promote early childhood development among caregivers from low-income urban communities: a randomized static group comparison trial of a primary care-based parenting program. Matern Child Health J 23:39–46. https://doi.org/10.1007/s10995-018-2589-8

    Article  PubMed  PubMed Central  Google Scholar 

  29. Bowen DJ, Kreuter M, Spring B et al (2009) How we design feasibility studies. Am J Prev Med 36:452–457. https://doi.org/10.1016/j.amepre.2009.02.002

    Article  PubMed  PubMed Central  Google Scholar 

  30. Leon AC, Davis LL, Kraemer HC (2011) The role and interpretation of pilot studies in clinical research. J Psychiatr Res 45:626–629. https://doi.org/10.1016/j.jpsychires.2010.10.008

    Article  PubMed  Google Scholar 

  31. Indian Public Health Standards (2012) Guidelines for Primary Health Centers. Directorate General of Health Services. Ministry of Health and Family Welfare. Government of India; Revised. http://www.nhm.gov.in/images/pdf/guidelines/iphs/iphs-revised-guidlines-2012/primay-health-centres.pdf. Accessed 14 Jul 2021

  32. Sriram S (2018) Availability of infrastructure and manpower for primary health centers in a district in Andhra Pradesh, India. J Family Med Prim Care 7:1256–1262. https://doi.org/10.4103/jfmpc.jfmpc_194_18

    Article  PubMed  PubMed Central  Google Scholar 

  33. Chokshi M, Patil B, Khanna R et al (2016) Health systems in India. J Perinatol 36:S9–S12. https://doi.org/10.1038/jp.2016.184

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  34. Julious SA (2005) Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 4:287–291. https://doi.org/10.1002/pst.185

    Article  Google Scholar 

  35. Bandura A (2004) Health promotion by social cognitive means. Health Educ Behav 31:143–164. https://doi.org/10.1177/1090198104263660

    Article  PubMed  Google Scholar 

  36. Luoto JE, Lopez Garcia I, Aboud FE et al (2019) Testing means to scale early childhood development interventions in rural Kenya: the Msingi Bora cluster randomized controlled trial study design and protocol. BMC Public Health. https://doi.org/10.1186/s12889-019-6584-9

    Article  PubMed  PubMed Central  Google Scholar 

  37. Shah R, Gustafson E, Dhaded S et al (2020) Integrating an adapted, low-intensity program to promote early childhood development in routine health visits in rural India: a feasibility study. J Dev Behav Pediatr 41:281–288. https://doi.org/10.1097/DBP.0000000000000763

    Article  PubMed  Google Scholar 

  38. Fernald LCH, Prado E, Kariger P, Raikes A (2017) A toolkit for measuring early childhood development in low-and middle-income countries. p 128

  39. Yousafzai AK, Rasheed MA, Rizvi A et al (2015) Parenting skills and emotional availability: an RCT. Pediatrics 135:e1247–e1257. https://doi.org/10.1542/peds.2014-2335

    Article  PubMed  Google Scholar 

  40. Raman S, Srinivasan K, Kurpad A et al (2014) My Mother My Sisters and My Friends: sources of maternal support in the perinatal period in urban India. Midwifery 30:130–137. https://doi.org/10.1016/j.midw.2013.03.003

    Article  PubMed  Google Scholar 

  41. Jeong J, McCoy DC, Yousafzai AK et al (2016) Paternal stimulation and early child development in low- and middle-income countries. Pediatrics 138:e20161357–e20161357. https://doi.org/10.1542/peds.2016-1357

    Article  PubMed  Google Scholar 

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Acknowledgements

The authors would like to thank all the families who participated in this study.

Funding

Research reported in this publication was supported by the Eunice Kennedy Shriver National Institute Of Child Health & Human Development of the National Institutes of Health under award number K23HD086295. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Author information

Authors and Affiliations

  1. Departments of Pediatrics, University of Illinois at Chicago, Chicago, United States

    Reshma Shah

  2. Women’s and Children’s Health Research Unit, Jawaharlal Nehru Medical College, Belagavi, India

    Veena Herekar, Deepa Metgud & Sangappa Dhaded

  3. Clinical and Translational Science, University of Illinois at Chicago, Chicago, United States

    Hajwa Kim

  4. Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA

    Marc Atkins

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  1. Reshma Shah
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  2. Veena Herekar
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  5. Marc Atkins
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  6. Sangappa Dhaded
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Contributions

Dr. Shah conceptualized and designed the study, obtained funding for the completed study, drafted the initial manuscript, and reviewed and revised the manuscript. Drs. Herekar and Metgud assisted with data collection, assisted with writing the methods section, and reviewed and revised the manuscript. Hajwa Kim conducted the statistical analysis, interpreted the data, and reviewed and provided critical revision of the manuscript. Dr. Atkins contributed to study design and provided critical revision of the manuscript. Dr. Dhaded contributed to study design, assisted with data collection procedures, and provided critical revision of the manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Reshma Shah.

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Ethics approval

All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and later amendments or comparable ethical standards. Study protocol approval was obtained from institutional review boards located at the University of Illinois at Chicago and Jawaharlal Nehru Medical College, Belagavi, India.

Consent to participate

Informed consent was obtained from legal guardians.

Conflict of interest

The authors declare no competing interests.

Additional information

Communicated by Gregorio Paolo Milani.

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Shah, R., Herekar, V., Metgud, D. et al. Implementing an early childhood development intervention with routine immunization visits in India: a feasibility trial. Eur J Pediatr 181, 2799–2808 (2022). https://doi.org/10.1007/s00431-022-04485-w

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  • DOI: https://doi.org/10.1007/s00431-022-04485-w

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