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.

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
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

556

Investigateurs

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).

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Auteurs

Mohammad Abdul Awal Miah (MAA)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. mohammad.miah3@icddrb.org.

Jaya Chandna (J)

Maternal, Adolescent, Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, London, UK.

Rejina Gurung (R)

Golden Community, Research Division, Lalitpur, Nepal.

Nahya Salim Masoud (NS)

Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Proma Paul (P)

Maternal, Adolescent, Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, London, UK.

Shafiqul Ameen (S)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

Omkar Basnet (O)

Golden Community, Research Division, Lalitpur, Nepal.

Mustafa Miraji (M)

Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.
Department of Paediatrics and Child Health, Temeke Regional Referral Hospital, Dar es Salaam, Tanzania.

Cally Tann (C)

Maternal, Adolescent, Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, London, UK.

Ismat Ara Mili (IA)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

A K M Tanvir Hossain (AKMT)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

Atique Iqbal Chowdhury (AI)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

Asraful Alam (A)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

Kate Mackinnon Milner (KM)

Murdoch Children's Research Institute, Department of Paediatrics, University of Melbourne, Melbourne, Australia.

Shams El Arifeen (SE)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

Ashish Kc (A)

School of Public Health and Community Medicine, University of Gothenburg, Gothenburg, Sweden.

Karim Manji (K)

Department of Paediatrics and Child Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.

Paul Lynch (P)

School of Education, University of Glasgow, Glasgow, Scotland.

Joy E Lawn (JE)

Maternal, Adolescent, Reproductive and Child Health (MARCH), London School of Hygiene and Tropical Medicine, London, UK.

Jena Derakhshani Hamadani (JD)

Maternal and Child Health Division, International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.

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