Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT06890156
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-26
First Post:
2025-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Every Newborn Reach Up Early Education Intervention for All Children Education (ENREACH) Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'All assessors will be blinded to the intervention group'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prior to enrolling study participants, we will conduct sensitization meetings with each selected government primary school. These meetings will be oriented toward community leaders, caregivers of children with or without disabilities, and SMCs to introduce them to the programme, ensure the inclusion of all children, and address concerns related to gender, poverty, and disability.\n\nA disability-inclusive module will be delivered to preschoolers in their regular pre-primary classrooms by trained pre-primary teachers. This module will cover foundational skills, the importance of play, communication, socio-emotional learning, and strategies for adapting the curriculum to accommodate children with disabilities.\n\nAdditionally, the ENREACH parent group school readiness intervention package will be provided to parents during monthly parent-teacher meetings, facilitated by trained preschool teachers.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-22', 'studyFirstSubmitDate': '2025-03-17', 'studyFirstSubmitQcDate': '2025-03-17', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measuring Early Learning Quality and Outcomes (MELQO)', 'timeFrame': '40 Minutes', 'description': 'School readiness (per-literacy, numeracy, executive functions, and social-emotional learning) will be assessed using the Measuring Early Learning Quality and Outcomes (MELQO)'}], 'secondaryOutcomes': [{'measure': 'Early childhood version of Home Observation for Measurement of Environment', 'timeFrame': '30 Minutes', 'description': 'To measure the quality of home stimulation'}, {'measure': 'Pediatric Quality of Life Inventory (PedsQL)', 'timeFrame': '30 Minutes', 'description': 'Physical functioning, emotional functioning, social functioning'}, {'measure': 'Measure of Early Learning Environment (MELE)', 'timeFrame': '90 minutes', 'description': 'School Environment'}, {'measure': 'Feeling Questionnaires', 'timeFrame': '5 minutes', 'description': 'Depression'}, {'measure': 'Teacher Interview Report', 'timeFrame': '20 minutes', 'description': 'Competency'}, {'measure': 'Knowledge and Practice questionnaire', 'timeFrame': '30 minutes', 'description': 'To assess knowledge and practices regarding school readiness'}, {'measure': 'Anthropometry', 'timeFrame': '5 minutes', 'description': 'Height, Weight'}, {'measure': 'Washington/UNICEF child functioning', 'timeFrame': '20 minutes', 'description': 'It assess multiple functional difficulties, such as vision, hearing, mobility, self-care, communication, learning, memory, emotional wellbeing (anxiety, depression), behavior problem, attention, routine changes, and social interactions.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['School readiness', 'Early childhood care and education (ECCE)', 'Early childhood development (ECD)', 'Pre-primary education', 'disabilities', 'Cluster randomized controlled trial (cRCT)'], 'conditions': ['School Readiness', 'School Environment']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Davis, D., Miller, D., Mrema, D., Matsoai, M., Mapetla, N., Raikes, A., & Burton, A. (2021). Understanding perceptions of quality among early childhood education stakeholders in Tanzania and Lesotho: A multiple qualitative case study. Social Sciences & Humanities Open, 4(1), 100153.'}, {'pmid': '39180108', 'type': 'BACKGROUND', 'citation': 'Miah MAA, Chandna J, Gurung R, Masoud NS, Paul P, Ameen S, Basnet O, Miraji M, Tann C, Mili IA, Hossain AKMT, Chowdhury AI, Alam A, Milner KM, Arifeen SE, Kc A, Manji K, Lynch P, Lawn JE, Hamadani JD; EN-REACH collaborative group. 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. Trials. 2024 Aug 23;25(1):556. doi: 10.1186/s13063-024-08381-6.'}, {'type': 'BACKGROUND', 'citation': 'Bangladesh Bureau of Statistics (BBS) and UNICEF, Multiple Indicator Cluster Survey-2019. 2019'}]}, 'descriptionModule': {'briefSummary': "The goal of the project is to assess the scale-up of the program, focusing on improving school readiness among preschool children, enhancing capacity building for parents and teachers, and utilizing a cluster randomized controlled trial (cRCT). The primary research questions are to seek answer-\n\n* What specific adaptations are necessary for an innovative, disability-inclusive early education training program to become a fully inclusive model that enhances teachers' engagement and practices in pre-primary classrooms in Nepal, Tanzania, and Bangladesh?\n* How can a new, equitable 'School Readiness Programme for the child-parent-teacher triad' be effectively scaled within national government pre-primary platforms using a cRCT?\n* How can the outcomes of the 'School Readiness Programme for the child-parent-teacher triad' be implemented in a cost-effective manner by key stakeholders across the three sites?\n\nThe research will examine an adapted inclusive early education training programme will lead to improved teaching practices, enhanced parental capacity, and better school readiness for all children compared to standard education programme; and b) the child-parent-teacher triad model can be scaled effectively within the government primary education systems.", 'detailedDescription': "In Bangladesh, Multiple Indicator Cluster Survey shows that only 18.9% of children aged 3-5 attend early childhood care and education (ECCE) programmes, and 25.5% are not developing at the expected rate (Bangladesh Bureau of Statistics and UNICEF, 2019). In Nepal, there are 35,991 early childhood development (ECD) and ECCE centers, unevenly distributed due to geographical barriers, with a very low enrollment (0.21%) of children with disabilities. Similarly, in Tanzania, efforts to ensure inclusive education in pre-primary schools face challenges with attendance and funding for disability schools in ECCE (Davis, D., et al, 2021).\n\nDespite ongoing efforts through ECCE programmes to promote effective school readiness globally, there exists a considerable and enduring gap in both the access to and quality of ECCE programmes for all children across three countries. This knowledge gap is rooted in the intersectionality of barriers affecting school readiness and scaling up.\n\nThis project builds on previous successful work in Bangladesh, Nepal and Tanzania, that focused on the readiness of both children and caregivers to enter the preschool education programme, through an initiative called Every Newborn-Reach Up Early Education Intervention for All Children (ENREACH) (Miah et al, 2024). This new applied research will support the adaptation of the ENREACH programme to incorporate key components on teacher readiness to facilitate a seamless transition to pre-primary education. The justification behind this innovation lies in incorporating key components of teacher readiness into the ENREACH programme, positioning it as an ideal and promising solution for bridging gaps to greater inclusion and increasing opportunities to scaling up across three countries\n\nObjectives:\n\nObjective 1:\n\nTo enhance teacher engagement and teaching practices by adapting an innovative disability-inclusive early education training programme into a fully inclusive programme that involves children, parents, teachers and the community.\n\nObjective 2:\n\nGenerating knowledge on factors that can facilitate the scaling of the child-parent-teacher triad innovation, including cost-effectiveness.\n\nObjective 3:\n\nTo mobilize the key stakeholders within the educational systems under the Ministry of Education in all 3 countries, on the basis of programme results to improve policy and practice to transfer into a government supported programmes.\n\nStudy design This study will employ a cluster (sub-districts/wards/municipalities) randomized controlled trial (cRCT) with an embedded qualitative component. It will evaluate scale-up strategies, emphasizing teachers' capacity for preschool to early primary education transition and parents' ability to improve children's school readiness.\n\nStudy settings The ENREACH ED study will be conducted at Kushtia and Gaibandha districts in Bangladesh and at Dhading and Nuwakot in Nepal and at Temeke and Kigamboni in Tanzania.\n\nMethods by Objectives Objective 1: ADAPTATION\n\nStep 1: The investigators will refine the tested ENREACH parenting pre-school readiness package by incorporating the following areas:\n\nA) Revise the Pre-school Readiness Parenting Package to ensure it is also aligned to pre-school teacher-pedagogy: the investigators aim to enhance the ENREACH pre-school parenting package by incorporating pre-academic foundational skills and play-based activities, fostering holistic skills development. This includes creating an inclusive environment, promoting play-based learning, storytelling, pre-reading, pre-numeracy skills, drawing, writing, and supporting socio-emotional needs. Collaboration with Ministry of Education representatives and development partner, like the World Bank, ensures alignment with each country's ECCE policy and early learning standards.\n\nB) Develop a teacher training manual: A training module for pre-primary education (PPE)/ECD teacher training, will be developed to promote pre-school teachers' skills in ECCE. These will include foundational skills, importance of play, communication, socio-emotional learning and ways to adapt the curricula for children with disabilities. The content, standards, framework, and pathways will be customized in collaboration with expert educational stakeholders in these settings.\n\nC) Develop a Community Stakeholder Awareness Package: An additional Information Education and Communication (IEC) package including leaflet, poster and short videos will be developed specifically to sensitize key stakeholders including, PPE/ECD teachers, caregivers of children with disabilities, the community leaders and School Management Committee (SMC) about ENREACH ED programme.\n\nTarget participants:\n\nTeachers: The teacher training initiative will involve a total of 24 PPE/ECD teachers and 24 headmasters evenly distributed among 24 intervention schools in each country. Upon the completion of the intervention programme, the investigators will extend training to 144 teachers and headmasters in the control group to facilitate the implementation of the programme with government support across three countries.\n\nParent-child dyad: The study will encompass 3000 caregivers of children from 144 government primary school (GPS)/ECD centres (72 GPS/ECD centres for intervention and 72 control) across two districts in each country.\n\nOutcome variables: Anticipated primary outcome is improved children's school readiness. Secondary outcomes are enhanced parental knowledge, attitudes and practice for school readiness, parent's mental health, children's quality of life, increased teachers' competence, home environment and better school environment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '84 Months', 'minimumAge': '48 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children aged 48-84 months\n* Enrolled in preschools\n* Residing in the catchment areas of GPS\n* Include/over sample for children with functional disabilities even if they are over 84 months of age.\n\nExclusion Criteria:\n\n* Un-consenting parents\n* Intervention school of EN-REACH study'}, 'identificationModule': {'nctId': 'NCT06890156', 'acronym': 'ENREACH-ED', 'briefTitle': 'Every Newborn Reach Up Early Education Intervention for All Children Education (ENREACH) Education', 'organization': {'class': 'OTHER', 'fullName': 'International Centre for Diarrhoeal Disease Research, Bangladesh'}, 'officialTitle': 'Bridging Gaps and Scaling Up: a School Readiness Programme for Child-parent-teacher Triad in Bangladesh, Nepal and Tanzania', 'orgStudyIdInfo': {'id': 'PR-24085'}, 'secondaryIdInfos': [{'id': '110505-001.', 'type': 'OTHER_GRANT', 'domain': 'International Development Research Centre (icddr,b)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1: Intervention', 'description': 'Caregivers and their pre-school children aged 48-84 months, enrolled in pre-primary education.', 'interventionNames': ['Behavioral: ENREACH child-parent-teacher triad']}, {'type': 'NO_INTERVENTION', 'label': 'Arm 2: Control', 'description': 'Caregivers and their children aged 48-84 months, enrolled in pre-primary education.'}], 'interventions': [{'name': 'ENREACH child-parent-teacher triad', 'type': 'BEHAVIORAL', 'description': 'Prior to enrolling study participants, we will conduct sensitization meetings with each selected government primary school. These meetings will be oriented toward community leaders, caregivers of children with or without disabilities, and school management committees to introduce them to the program, ensure the inclusion of all children, and address concerns related to gender, poverty, and disability.\n\nA disability-inclusive module will be delivered to preschoolers in their regular pre-primary classrooms by trained pre-primary teachers. This module will cover foundational skills, the importance of play, communication, socio-emotional learning, and strategies for adapting the curriculum to accommodate children with disabilities.\n\nENREACH parent group school readiness intervention package will be provided to parents during monthly parent-teacher meetings, facilitated by trained preschool teachers.', 'armGroupLabels': ['Arm 1: Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1212', 'city': 'Dhaka', 'country': 'Bangladesh', 'contacts': [{'name': 'Jena D. Hamadani, PhD', 'role': 'CONTACT', 'email': 'jena@icddrb.org', 'phone': '+88 02 2222 77 001-10', 'phoneExt': '2353'}, {'name': 'Mohammad Abdul Awal Miah, M.Phil', 'role': 'CONTACT', 'email': 'mohammad.miah3@icddrb.org', 'phone': '+88 02 2222 77 001-10', 'phoneExt': '2331'}, {'name': 'Jena D. Hamadani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohammad Abdul Awal Miah, M.Phil', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ismat Ara Mili, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Syeda Fardina Mehrin, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Shamima Shiraji, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Raafat Hassan, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhammad Nazmul Haque, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Joy Lawn, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jaya Chandna, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Proma Paul, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Paul Lynch, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hassan H. Bidgoli, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nahya Salim, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karim Manji, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rejina Gurung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ashish KC, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Jena Derakhshani Hamadani, PhD', 'role': 'CONTACT', 'email': 'jena@icddrb.org', 'phone': '+8801713093849'}, {'name': 'Mohammad Abdul Awal Miah, M.Phil', 'role': 'CONTACT', 'email': 'mohammad.miah3@icddrb.org', 'phone': '+88017181040304'}], 'overallOfficials': [{'name': 'Jena Derakhshani Hamadani, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP'], 'timeFrame': 'From December 2025 until analysis is completed A', 'ipdSharing': 'YES', 'description': 'The investigators have a six-year track record of equitable partnership between sites (Nepal, Bangladesh, Tanzania and London School of Hygiene \\& Tropical Medicine) with data sharing agreements already in place. The data will be owned by each country institution and pooled data by the study team. We have already established small committees which include the Principle Investigator (PI) and each site PI who will review any requests for data beyond the original team e.g. - Doctorate of Philosophy formal data sharing agreements will be signed by both parties. However, we will not share any identifiable related individual participant data with other researchers.', 'accessCriteria': 'All the PIs of each site and statisticians'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'International Centre for Diarrhoeal Disease Research, Bangladesh', 'class': 'OTHER'}, 'collaborators': [{'name': 'Muhimbili University of Health and Allied Sciences', 'class': 'OTHER'}, {'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, {'name': 'Golden Community, Nepal', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}