Child DevelopmentEN-REACHNCT06334627
Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania
A study testing Pre-Primary Intervention in people with Child Development and Child Development Disorder, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
Trial summary
The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development, Child Development Disorder
- What is being tested?
- Pre-Primary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,651 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 3 May 2022to 15 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-6 years in study area
- Children who completed previous EN-SMILING Study
Who cannot join
- Children outside of age range
- Children living outside of study area
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Bangladesh1 site
International Centre for Diarrheal Disease Research, Bangladesh
Dhaka
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:
- What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?
- What is the feasibility and accessibility of a parent group intervention for these children?
Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development.
Read the detailed description
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 is 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 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 (MELQO) 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 RE-AIM framework.
This trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aims 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.
- Conditions
- Child Development, Child Development Disorder
- Being tested
- Pre-Primary Intervention
- Keywords
- Child development, child disability, pre-primary education, school readiness
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Primary InterventionBehavioural
School readiness intervention
| Study group | Role | What they receive |
|---|---|---|
| Pre-Primary Intervention | Experimental | Program consisting of 9 modules focussing on early learning, play, saftey, wellbeing, reading and writing will be delivered approximately every two weeks to groups of 10 parents from the intervention arm. Receives: Behavioral: Pre-Primary Intervention |
| Control | No intervention | No intervention delivered. Participants will attend any government pre-primary based programmes as standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Early Learning Quality and Outcomes (MELQO Tool)
School Readiness
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
The Pediatric Evaluation of Disability Inventory
Child Disability
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Secondary outcomes (5)
Washington Group Questionnaire
Child functioning
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
The Wechsler Preschool & Primary Scale of Intelligence
Child IQ
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Pre-school Register
Pre-school attendance
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Mental Health Questionnaire
Maternal Mental Health screen
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Pediatric Quality of Life Inventory (PEDSQL Tool)
Child and family quality of life
Measured: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start3 May 2022
- Primary completion15 Apr 2024 (estimated)
- Study completion15 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child DevelopmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,651 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Golden Community, Nepal, Muhimbili University of Health and Allied Sciences, University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Joy Lawn, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334627
- Sponsor's protocol ID
- ENREACH
- Acronym
- EN-REACH
- Status last verified
- Feb 2024
- First submitted
- 29 Feb 2024
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Annonomysed primary outcome data will be made available along with the protocol and statistical analysis plan
Publications
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.
PubMed 39180108
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Every Newborn-Reach Up Early Education Intervention for All Children- a Parent Group Intervention for School Readiness in Bangladesh, Nepal, and Tanzania
- ClinicalTrials.gov ID
- NCT06334627
- Acronym / sponsor ID
- EN-REACH / ENREACH
- Conditions
- Child Development, Child Development Disorder
- Keywords
- Child development, child disability, pre-primary education, school readiness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,651 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh, Golden Community, Nepal, Muhimbili University of Health and Allied Sciences, University of Glasgow
- Study start
- 3 May 2022 (actual)
- Primary completion
- 15 Apr 2024 (estimated)
- Study completion
- 15 Sep 2024 (estimated)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test the effect of a pre-primary education parent group intervention in children with and without disability in Nepal Bangladesh and Tanzania. The main question it aims to answer are:
- What is the impact of a parent group intervention on primary school readiness in children aged 5-6 years old in three LMICs?
- What is the feasibility and accessibility of a parent group intervention for these children?
Participants will attend parent group sessions every two weeks for a total of 9 sessions. Researchers will compare a control group to see if there are impacts on school readiness and child development.
Detailed description
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 is 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 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 (MELQO) 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 RE-AIM framework.
This trial focused on enhancing school readiness and cognitive abilities in young children, inclusive of those with disabilities, aims 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Primary Intervention | Experimental | Behavioral: Pre-Primary InterventionProgram consisting of 9 modules focussing on early learning, play, saftey, wellbeing, reading and writing will be delivered approximately every two weeks to groups of 10 parents from the intervention arm. |
| Control | No intervention | –No intervention delivered. Participants will attend any government pre-primary based programmes as standard of care. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 4-6 years in study area
- Children who completed previous EN-SMILING Study
Key exclusion criteria (2 listed)
- Children outside of age range
- Children living outside of study area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-Primary InterventionSchool readiness intervention | Behavioural | Pre-Primary Intervention |
Primary outcome
Measuring Early Learning Quality and Outcomes (MELQO Tool)
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
School Readiness
The Pediatric Evaluation of Disability Inventory
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Child Disability
5 secondary outcomes
Washington Group Questionnaire
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
The Wechsler Preschool & Primary Scale of Intelligence
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Pre-school Register
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Mental Health Questionnaire
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Pediatric Quality of Life Inventory (PEDSQL Tool)
Time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Derived from this study: PubMed 39180108Miah 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.
- Individual participant dataSharing planned: Undecided. Annonomysed primary outcome data will be made available along with the protocol and statistical analysis plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy Lawn, PhD principal investigator
London School of Hygiene and Tropical Medicine
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-Primary Intervention in people with Child Development and Child Development Disorder, run by London School of Hygiene and Tropical Medicine at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh, Nepal, Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Early Learning Quality and Outcomes (MELQO Tool) (time frame: Baseline (children are aged 5-5.5 years) and 6 months later post intervention (children aged 5.5-6 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06334627, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.