Every Newborn-Reach Up Early Education Intervention for All Children (EN-REACH)- a parent group intervention for school readiness in Bangladesh, Nepal, and Tanzania: study protocol for a cluster randomized controlled trial.
Humans
Tanzania
Child, Preschool
Nepal
Child Development
Early Intervention, Educational
/ methods
Bangladesh
Randomized Controlled Trials as Topic
Parents
/ education
Child
Female
Male
Multicenter Studies as Topic
Time Factors
Parenting
Child Behavior
Infant, Newborn
Age Factors
Teacher Training
/ methods
Cluster randomized controlled trial (cRCT)
Disabilities
Early child development (ECD)
Measurement for early learning and quality of outcomes (MELQO)
Neuro-developmental delay
Newborn
Parenting group intervention
Pre-primary education
School readiness
Weschler preschool and primary scale of intelligence (WPPSI)
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
23 Aug 2024
23 Aug 2024
Historique:
received:
29
04
2024
accepted:
06
08
2024
medline:
24
8
2024
pubmed:
24
8
2024
entrez:
23
8
2024
Statut:
epublish
Résumé
Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn-Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility. EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent-child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is "school readiness", assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders' perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. DISCUSSION: This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities. The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).
Sections du résumé
BACKGROUND
BACKGROUND
Vulnerable children, including those with neuro-developmental delays and disabilities, often face barriers in accessing early primary education, thus hindering progress toward Sustainable Development Goal 4.2. Evidence-based interventions are essential to enhancing inclusivity and establishing sustainable implementation strategies to address this challenge. This study, Every Newborn-Reach up Early Education Intervention for All Children (EN-REACH), builds on the previous Every Newborn- Simplified Measurement Integrating Longitudinal Neurodevelopmental and Growth (EN-SMILING) observational cohort study. This paper provides the protocol for a cluster randomized controlled trial (cRCT) to evaluate the effectiveness of a parenting group intervention program for enhancing school readiness in Bangladesh, Nepal, and Tanzania, and an embedded process evaluation to inform scalability and feasibility.
METHODS
METHODS
EN-REACH is a cRCT with at least 150 clusters to evaluate the impact of a parent training program led by trained parent-teacher facilitator pairs, focusing on children aged 4 ~ 6 years preparing for preschool. Approximately 500 participants from the EN-SMILING cohort at each site have been identified. A geographic information system will define ~ 50 clusters in each of the three countries, each with approximately ten parent-child dyads. Half the clusters will be randomly assigned to intervention and control groups. The primary outcome is "school readiness", assessed using the Measuring Early Learning Quality and Outcomes tool. Secondary outcomes include Intelligence Quotient, child functioning, growth, visual, and hearing assessments. Data will be collected at baseline, and post-intervention data following implementation of the parent group intervention sessions over approximately 5 months. Quantitative data on coverage and quality care, combined with qualitative insights from children, caregivers, facilitators, and stakeholders' perspectives, will be used to conduct a process evaluation applying the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. DISCUSSION: This protocol details a trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aiming to bridge gap from home to early primary education. EN-REACH aims to provide insights into the effectiveness and acceptability of a co-designed disability-inclusive school readiness program in three countries, potentially impacting national and global policies for all children, including those with disabilities.
TRIAL REGISTRATION
BACKGROUND
The trial was retrospectively registered on clinicaltrials.gov on 29 February 2024 (NCT06334627).
Identifiants
pubmed: 39180108
doi: 10.1186/s13063-024-08381-6
pii: 10.1186/s13063-024-08381-6
doi:
Banques de données
ClinicalTrials.gov
['NCT06334627']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
556Investigateurs
Ziaul Haque Shaikh
(ZH)
Md Nazmul Hasan
(MN)
Salma Khatun
(S)
Adori Khatun
(A)
Monira Aktar
(M)
Ahmed Ehsanur Rahman
(AE)
Chudamani Poudel
(C)
Basanta Prasad Koirala
(BP)
Shova Kumari Adhikari
(SK)
Arjun Dhakal
(A)
Dhanasudhan Chaulagain
(D)
Bharat Khatri
(B)
Ram Chandra Bastola
(RC)
Donat Shamba
(D)
Josephine Shabani
(J)
Mohamed Bakari
(M)
Hajra Kizibo
(H)
Mohamed Akida
(M)
Aisha Mfinanga
(A)
Hellena Mariki
(H)
Ramadhani Gunda
(R)
Seif Bakari
(S)
Rachel Lassman
(R)
Maria Zurmond
(M)
Informations de copyright
© 2024. The Author(s).
Références
United Nations. Transforming our world: the 2030 Agenda for Sustainable Development United Nations. New York: Department of economic and social affairs. Division for sustainable development goals; 2015.
UNİCEF. A brief overview: inclusive education for children with disabilities in the CEECIS Region. Geneva: UNICEF; 2010.
UNICEF, WG. The Washington Group / UNICEF Child Functioning Module (CFM) – Ages 5-17 years. 2016. https://www.washingtongroup-disability.com/question-sets/wg-unicef-child-functioning-module-cfm/ .
Olusanya BO, Davis AC, Wertlieb D, Boo N-Y, Nair M, Halpern R, et al. 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 Glob Health. 2018;6(10):e1100–21.
doi: 10.1016/S2214-109X(18)30309-7
Grantham-McGregor S, Cheung YB, Cueto S, Glewwe P, Richter L, Strupp B, et al. Developmental potential in the first 5 years for children in developing countries. The lancet. 2007;369(9555):60–70.
doi: 10.1016/S0140-6736(07)60032-4
World Health Organization, UNICEF, World Bank. Nurturing care for early childhood development: a framework for helping children survive and thrive to transform health and human potential. 2018.
UNICEF. Convention on the Rights of the Child. New York: United Nations. 1989. Available from: https://www.unicef.org/child-rights-convention/convention-text .
United Nations. Convention on the rights of persons with disabilities New York: UN. 2006. Retrieved from www.un.org/disabilities .
Milner KM, Salazar RB, Bhopal S, Brentani A, Britto PR, Dua T, et al. Contextual design choices and partnerships for scaling early child development programmes. Arch Dis Child. 2019;104(Suppl 1):S3–12.
doi: 10.1136/archdischild-2018-315433
pubmed: 30885961
Boggs D, Milner KM, Chandna J, Black M, Cavallera V, Dua T, et al. Rating early child development outcome measurement tools for routine health programme use. Arch Dis Child. 2019;104(Suppl 1):S22–33.
doi: 10.1136/archdischild-2018-315431
pubmed: 30885963
Bangladesh. Ministry of women and children affairs. National Children Policy 2011, Dhaka: ministry of women and children affairs; 2011. http://ecd-bangladesh.net/document/documents/National-Children-Policy-2011-English-04.12.2012.pdf . Accessed 12 Nov 2023.
Hamadani JD, Tofail F, Huda SN, Alam DS, Ridout DA, Attanasio O, et al. Cognitive deficit and poverty in the first 5 years of childhood in Bangladesh. Pediatrics. 2014;134(4):e1001–8.
doi: 10.1542/peds.2014-0694
pubmed: 25266433
Abbott-Shim M, Lambert R, McCarty F. A comparison of school readiness outcomes for children randomly assigned to a head start program and the program’s wait list. J Educ Stud Placed Risk. 2003;8(2):191–214.
doi: 10.1207/S15327671ESPR0802_2
Bustamante AS, White LJ, Greenfield DB. Approaches to learning and school readiness in head start: applications to preschool science. Learn Individ Differ. 2017;56:112–8.
doi: 10.1016/j.lindif.2016.10.012
Smythe T, Almasri NA, Moreno Angarita M, Berman BD, Kraus de Camargo O, Hadders-Algra M, et al. The role of parenting interventions in optimizing school readiness for children with disabilities in low and middle income settings. Front Pediatr. 2022;10:1072.
doi: 10.3389/fped.2022.927678
Powell DR, Son S-H, File N, San Juan RR. Parent–school relationships and children’s academic and social outcomes in public school pre-kindergarten. J Sch Psychol. 2010;48(4):269–92.
doi: 10.1016/j.jsp.2010.03.002
pubmed: 20609850
Scott-Little C, Kagan SL, Frelow VS. Conceptualization of readiness and the content of early learning standards: the intersection of policy and research? Early Childhood Res Quart. 2006;21(2):153–73.
doi: 10.1016/j.ecresq.2006.04.003
Lynch P, Soni A. Widening the focus of school readiness for children with disabilities in Malawi: a critical review of the literature. Int J Incl Educ. 2021:1–15. https://doi.org/10.1080/13603116.2021.1965801 .
UNICEF. School readiness: a conceptual framework. New York: UNICEF; 2012.
Mathwasa J, Sibanda L. Inclusion in Early Childhood Development Settings: A Reality or an Oasis. Education in Childhood. 2021. https://doi.org/10.5772/intechopen.99105 .
Özler B, Fernald LC, Kariger P, McConnell C, Neuman M, Fraga E. Combining pre-school teacher training with parenting education: a cluster-randomized controlled trial. J Dev Econ. 2018;133:448–67.
doi: 10.1016/j.jdeveco.2018.04.004
Day LT, Ruysen H, Gordeev VS, Gore-Langton GR, Boggs D, Cousens S, et al. “Every Newborn-BIRTH” protocol: observational study validating indicators for coverage and quality of maternal and newborn health care in Bangladesh, Nepal and Tanzania. J Global Health. 2019;9(1):010902.
doi: 10.7189/jogh.09.010902
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, et al. RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health. 2019;7: 64.
doi: 10.3389/fpubh.2019.00064
pubmed: 30984733
pmcid: 6450067
Glasgow RE, Estabrooks PA, Ory MG, Characterizing evolving frameworks: issues from Esmail, et al. review. Implement Sci. 2020;2020(15):1–3.
Yousafzai AK, Aboud FE, Nores M, Kaur R. Reporting guidelines for implementation research on nurturing care interventions designed to promote early childhood development. Ann N Y Acad Sci. 2018;1419(1):26–37.
doi: 10.1111/nyas.13648
pubmed: 29791737
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.
doi: 10.7326/0003-4819-158-3-201302050-00583
pubmed: 23295957
pmcid: 5114123
UNESCO, UNICEF, Brookings Institution, World Bank. Overview Measuring Early Learning Quality and Outcomes. 2017. Report No.: ISBN 9789231002205. https://www.brookings.edu/wp-content/uploads/2017/06/melqo-measuring-early-learning-quality-outcomes.pdf . Accessed 20 Jan 2024.
Haley SM, Coster WJ, Dumas HM, Fragala-Pinkham MA, Kramer J, Ni P, et al. Accuracy and precision of the Pediatric Evaluation of Disability Inventory computer-adaptive tests (PEDI-CAT). Dev Med Child Neurol. 2011;53(12):1100–6.
doi: 10.1111/j.1469-8749.2011.04107.x
pubmed: 22077695
pmcid: 3638866
Wechsler D. Wechsler preschool and primary scale of intelligence—fourth edition. TX: The Psychological Corporation San Antonio; 2012.
Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins Symptom Checklist (HSCL): a self-report symptom inventory. Behav Sci. 1974;19(1):1–15.
doi: 10.1002/bs.3830190102
pubmed: 4808738
Varni JW, Sherman SA, Burwinkle TM, Dickinson PE, Dixon P. The PedsQL family impact module: preliminary reliability and validity. Health Qual Life Outcomes. 2004;2: 55.
doi: 10.1186/1477-7525-2-55
pubmed: 15450120
pmcid: 521692
Pushparatnam A, Luna Bazaldua DA, Holla A, Azevedo JP, Clarke M, Devercelli A. Measuring early childhood development among 4–6 year olds: the identification of psychometrically robust items across diverse contexts. Front Public Health. 2021;9:17.
doi: 10.3389/fpubh.2021.569448
Levy-Kramer J. k-means-constrained. 0.7.3. Available from: https://pypi.org/project/k-means-constrained/ . Accessed 2 Nov 2022.
Black MM, Walker SP, Fernald LC, Andersen CT, DiGirolamo AM, Lu C, et al. Early childhood development coming of age: science through the life course. Lancet. 2017;389(10064):77–90.
doi: 10.1016/S0140-6736(16)31389-7
pubmed: 27717614
Lu C, Black MM, Richter LM. 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. 2016;4(12):e916–22.
doi: 10.1016/S2214-109X(16)30266-2
pubmed: 27717632
pmcid: 5881401
McGregor G, Cheung Y, Cueto S, Glewwe P, Richter L, Strupp B. International child development steering group: Developmental potential in the first 5 years for children in developing countries. Lancet. 2007;369:60–70.
doi: 10.1016/S0140-6736(07)60032-4
Aboud FE, Yousafzai AK. Global health and development in early childhood. Annu Rev Psychol. 2015;66:433–57.
doi: 10.1146/annurev-psych-010814-015128
pubmed: 25196276
Attanasio OP, Fernández C, Fitzsimons EO, Grantham-McGregor SM, Meghir C, Rubio-Codina M. Using the infrastructure of a conditional cash transfer program to deliver a scalable integrated early child development program in Colombia: cluster randomized controlled trial. BMJ. 2014;349:g5785.
doi: 10.1136/bmj.g5785
pubmed: 25266222
pmcid: 4179481
Jeong J, Franchett EE, Ramos de Oliveira CV, Rehmani K, Yousafzai AK. Parenting interventions to promote early child development in the first three years of life: a global systematic review and meta-analysis. PLoS Med. 2021;18(5): e1003602.
doi: 10.1371/journal.pmed.1003602
pubmed: 33970913
pmcid: 8109838
Hamadani JD, Mehrin SF, Tofail F, Hasan MI, Huda SN, Baker-Henningham H, et al. Integrating an early childhood development programme into Bangladeshi primary health-care services: an open-label, cluster-randomised controlled trial. Lancet Glob Health. 2019;7(3):e366–75.
doi: 10.1016/S2214-109X(18)30535-7
pubmed: 30784637
Meghir C, Attanasio O, Jervis P, Day M, Makkar P, Behrman J, et al. Early stimulation and enhanced preschool: a randomized trial. Pediatrics. 2023;151:151 Supple 2.
doi: 10.1542/peds.2023-060221H
Dillon MR, Kannan H, Dean JT, Spelke ES, Duflo E. Cognitive science in the field: a preschool intervention durably enhances intuitive but not formal mathematics. Science. 2017;357(6346):47–55.
doi: 10.1126/science.aal4724
pubmed: 28684518
Ganimian AJ, Muralidharan K, Walters CR. Augmenting state capacity for child development: Experimental evidence from India. J Pol Econ. 2024;132(5):1565–602. https://doi.org/10.1086/728109 .
doi: 10.1086/728109
UNICEF. UNICEF programme guidance for early childhood development. 2017.
UNICEF, Lego Foundation. Learning through play strengthening learning through play in early childhood education programmes. 2018. https://www.unicef.org/sites/default/files/2018-12/UNICEF-Lego-Foundation-Learning-through-Play.pdf .