Child DevelopmentPhase 3LEAPSNCT02645162
Youth Leaders for Early Childhood Assuring Children Are Prepared for School
A Phase 3 study testing Community-based Preschool in people with Child Development, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Worldwide about 88 million children drop out of primary school annually. One of the contributory factors is a lack of school readiness among young children, their families and their teachers. To better prepare young children for school, investment in early childhood interventions is necessary. Read more about this study
- Who is it for?
- Ages 42 to 66 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Development
- What is being tested?
- Community-based Preschool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 sitePakistan
- Study dates
- Dec 2015to Sep 2016
- Phase
- Phase 3
- 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 42 to 66 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Resident of study cluster
- Not enrolled in a preschool
Who cannot join
- Obvious disability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University
Karachi, Sindh, 74800
Muneera A Rasheed, MS, 00922134864334 ext. 4334, muneera.rasheed@aku.edu
About this study
Official title: A Cluster Randomized Control Trial to Evaluate the Efficacy and Feasibility of a Community-based Preschool Programme and Community Engagement Strategy Led by Community Youth Leaders in Rural Pakistan
Worldwide about 88 million children drop out of primary school annually. One of the contributory factors is a lack of school readiness among young children, their families and their teachers. To better prepare young children for school, investment in early childhood interventions is necessary. Young children require good health, adequate nutrition and social-emotional, cognitive and communication skills to succeed in school, which requires both support in the family environment and a stable transition to the classroom environment. Preschool programmes are designed to prepare children for formal learning. However, in many low- and middle-income countries there is poor access to quality preschool programmes. Further, the scale-up of early childhood interventions is challenged by a number of barriers such as poor supply (e.g. policy provisions, financing, distance, early child development workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization, agency, community of purpose, opportunities to participate) and weak quality of services (e.g. training, supervision and monitoring systems).
In partnership with the National Commission for Human Development, we propose to implement an early childhood care and education programme in rural Sindh that is championed by Community Youth Leaders. The Community Youth Leaders will run community preschools for children aged 3-6 years, and will also coordinate local community engagement and local stakeholder strategies across sectors to leverage demand-side actions to promote ownership and scale-up of early childhood interventions. The LEAPS Programme (Youth Leaders for Early Childhood Assuring Children are Prepared for School) will be evaluated by a cluster randomized controlled efficacy trial. The primary outcome will be children's school readiness, indexed by both early academic and social emotional competencies assessed following 6-9 months of intervention exposure. The compliance, fidelity and quality of the implementation process will also be assessed in order to understand how these features moderate outcomes and whether community-engagement strategies facilitate demand-side actions for scale-up. The expected outcomes for this trial will include a model for quality preprimary education that addresses a current supply-side gap, and will facilitate learning for demand-side actions to support scale-up across a broad range of early childhood interventions.
Read the detailed description
Trial Design The study is a cluster randomized controlled trial.
Aims Aim 1: To evaluate the effectiveness of the LEAPS Programme on school readiness of children, CYLs, families and services 1.1: To determine whether children who participate in LEAPS preschools led by CYLs will achieve significantly better scores in assessments of school readiness indexed by motor development, social-emotional development, emergent literacy and language, emergent numeracy, approaches to learning and executive functions than children in a control group.
1.2: To identify the moderating and mediating variables (child, CYL, family and community characteristics) for school readiness outcomes among children enrolled in LEAPS preschools.
1.3: To describe the effects of intervention on CYLs' knowledge (ECD and education), competencies (approaches to teaching) and personal/professional growth (executive functioning, aspirations for parenting, family life and career, and autonomy).
1.4: To determine whether LEAPS community engagement strategies to address barriers to scale-up of ECD programmes are effective with respect to family engagement with preschool, support and intent for timely primary school enrolment, family utilization of child services, service provider coordination, knowledge, participation in demand-side platforms and demand-side creation.
Aim 2: To evaluate fidelity and compliance to the LEAPS Programme among community stakeholders 2.1: To evaluate the fidelity of implementation and compliance to the LEAPS preschool programme by the participants.
2.2: To explore stakeholder experience of the preschool programme and community-based strategies to understand facilitators, challenges and learn lessons for scale.
Aim 3: To determine the cost effectiveness of the LEAPS Community-based preschool and community engagement strategies on children's and community readiness for learning and school.
Clusters Ten clusters were randomly selected from a list of 20 clusters part of Responsive Stimulation arm (Yousafzai, A. K., Rasheed, M. A., Rizvi, A., Armstrong, R., \& Bhutta, Z. A.. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. The Lancet, 384(9950), 1282-1293. 2014) using A-cluster software. Strata were rural/peri-urban. The inclusion criteria of including the cluster in the randomization were: a functioning LHW and a functioning primary school in the village. Five clusters were assigned each for intervention and control arms via simple randomization.
Sample Size The sample size has been estimated as 30 children per cluster with a total of 300 children, which will be adequate taking into account an estimated 10% attrition rate.
Subject Enrolment Control Arm: Children of age as defined by inclusion criteria will be identified from a list of registered children with the Lady Health Worker (nearest record possible). The sample will be stratified by the same age groups as described for the intervention group.
Experimental Arm: A list of children meeting the inclusion criteria was available from the LHW. Any additional child will be verified with the respective LHW prior to enrolment. Enrolment for children in experimental group is defined as child having registered and attended at least 3 days of preschool in week 1.
Data Collection Instruments All instruments were developed in English in the first instance and then translated to Sindhi (with back translations) and piloted prior to use in the study. A systematic adaptation protocol was followed.
Quality Assurance The following strategies are being used
- A 10% sample of assessments are being observed by the field supervisor and scored simultaneously for inter-rater agreement. This shall be followed by a feedback session with the assessor.
- Daily debriefing meetings are held where challenges and solutions will be discussed and will also be used as an opportunity for learning.
- A 10% sample of classroom observations are being video recorded for coding by experts.
- Anthropometry equipment is calibrated daily.
Data Management Forms are being checked prior to entry. The data entry softwares include checks to minimize errors. Data entry is being done at the data entry office located at the field office. All forms are being data entered. A weekly report on status of data entry is being shared by the data entry office.
Data Analysis Plan: An intention to treat model.
- Conditions
- Child Development
- Being tested
- Community-based Preschool
- Keywords
- Pakistan, Early Child Development, Care and Education, Youth Leaders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community-based PreschoolBehavioural
- Preschool sessions in community-based preschool
- Run by trained community youth leaders from the same village.
| Study group | Role | What they receive |
|---|---|---|
| Preschool | Experimental | * This arm will receive the community-based preschool intervention.
* The preschool sessions will include 2 groups per day (3 years 6months to 4 years 6 months in the morning session and 4 years 7 months to 5 year 6 months in the afternoon session at the time of enrolment)
* Each session will last 3 hours for 5 days per week.
* The expected CYL-to-child ratio will be 1:15; however, given the expected high level of local demand it may exceed to a maximum of 1:20 ratio. Receives: Behavioral: Community-based Preschool |
| Control | No intervention | The control group will receive standard services available in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
School readiness as defined by the percentage of items passed on a measure of school readiness.
Cognitive, social-emotional, motor, early literacy and early numeracy
Measured: After a minimum of 6 months of intervention exposure.
Child executive functioning tasks composite score
Inhibitory control, cognitive flexibility, working memory
Measured: After a minimum of 6 months of intervention exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- Grand Challenges Canada, UNICEF, Yale University
- Responsible party
- Principal investigator, Dr Aisha Khizar Yousafzai, Aga Khan University
- Investigators
- Aisha K Yousafzai, PhD, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02645162
- Sponsor's protocol ID
- 3450-PED-ERC-15
- Acronym
- LEAPS
- Status last verified
- Dec 2015
- First submitted
- 31 Dec 2015
- Last updated
- 1 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Yousafzai AK, Rasheed MA, Rizvi A, Shaheen F, Ponguta LA, Reyes CR. Effectiveness of a youth-led early childhood care and education programme in rural Pakistan: A cluster-randomised controlled trial. PLoS One. 2018 Dec 19;13(12):e0208335. doi: 10.1371/journal.pone.0208335. eCollection 2018.
PubMed 30566498
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Control Trial to Evaluate the Efficacy and Feasibility of a Community-based Preschool Programme and Community Engagement Strategy Led by Community Youth Leaders in Rural Pakistan
- ClinicalTrials.gov ID
- NCT02645162
- Acronym / sponsor ID
- LEAPS / 3450-PED-ERC-15
- Conditions
- Child Development
- Keywords
- Pakistan, Early Child Development, Care and Education, Youth Leaders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- Grand Challenges Canada, UNICEF, Yale University
- Study start
- Dec 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 1 Jan 2016 (estimated)
- 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.
Worldwide about 88 million children drop out of primary school annually. One of the contributory factors is a lack of school readiness among young children, their families and their teachers. To better prepare young children for school, investment in early childhood interventions is necessary. Young children require good health, adequate nutrition and social-emotional, cognitive and communication skills to succeed in school, which requires both support in the family environment and a stable transition to the classroom environment. Preschool programmes are designed to prepare children for formal learning. However, in many low- and middle-income countries there is poor access to quality preschool programmes. Further, the scale-up of early childhood interventions is challenged by a number of barriers such as poor supply (e.g. policy provisions, financing, distance, early child development workforce), inadequate cross-sector coordination, low demand (e.g. knowledge mobilization, agency, community of purpose, opportunities to participate) and weak quality of services (e.g. training, supervision and monitoring systems).
In partnership with the National Commission for Human Development, we propose to implement an early childhood care and education programme in rural Sindh that is championed by Community Youth Leaders. The Community Youth Leaders will run community preschools for children aged 3-6 years, and will also coordinate local community engagement and local stakeholder strategies across sectors to leverage demand-side actions to promote ownership and scale-up of early childhood interventions. The LEAPS Programme (Youth Leaders for Early Childhood Assuring Children are Prepared for School) will be evaluated by a cluster randomized controlled efficacy trial. The primary outcome will be children's school readiness, indexed by both early academic and social emotional competencies assessed following 6-9 months of intervention exposure. The compliance, fidelity and quality of the implementation process will also be assessed in order to understand how these features moderate outcomes and whether community-engagement strategies facilitate demand-side actions for scale-up. The expected outcomes for this trial will include a model for quality preprimary education that addresses a current supply-side gap, and will facilitate learning for demand-side actions to support scale-up across a broad range of early childhood interventions.
Detailed description
Trial Design The study is a cluster randomized controlled trial.
Aims Aim 1: To evaluate the effectiveness of the LEAPS Programme on school readiness of children, CYLs, families and services 1.1: To determine whether children who participate in LEAPS preschools led by CYLs will achieve significantly better scores in assessments of school readiness indexed by motor development, social-emotional development, emergent literacy and language, emergent numeracy, approaches to learning and executive functions than children in a control group.
1.2: To identify the moderating and mediating variables (child, CYL, family and community characteristics) for school readiness outcomes among children enrolled in LEAPS preschools.
1.3: To describe the effects of intervention on CYLs' knowledge (ECD and education), competencies (approaches to teaching) and personal/professional growth (executive functioning, aspirations for parenting, family life and career, and autonomy).
1.4: To determine whether LEAPS community engagement strategies to address barriers to scale-up of ECD programmes are effective with respect to family engagement with preschool, support and intent for timely primary school enrolment, family utilization of child services, service provider coordination, knowledge, participation in demand-side platforms and demand-side creation.
Aim 2: To evaluate fidelity and compliance to the LEAPS Programme among community stakeholders 2.1: To evaluate the fidelity of implementation and compliance to the LEAPS preschool programme by the participants.
2.2: To explore stakeholder experience of the preschool programme and community-based strategies to understand facilitators, challenges and learn lessons for scale.
Aim 3: To determine the cost effectiveness of the LEAPS Community-based preschool and community engagement strategies on children's and community readiness for learning and school.
Clusters Ten clusters were randomly selected from a list of 20 clusters part of Responsive Stimulation arm (Yousafzai, A. K., Rasheed, M. A., Rizvi, A., Armstrong, R., \& Bhutta, Z. A.. Effect of integrated responsive stimulation and nutrition interventions in the Lady Health Worker programme in Pakistan on child development, growth, and health outcomes: a cluster-randomised factorial effectiveness trial. The Lancet, 384(9950), 1282-1293. 2014) using A-cluster software. Strata were rural/peri-urban. The inclusion criteria of including the cluster in the randomization were: a functioning LHW and a functioning primary school in the village. Five clusters were assigned each for intervention and control arms via simple randomization.
Sample Size The sample size has been estimated as 30 children per cluster with a total of 300 children, which will be adequate taking into account an estimated 10% attrition rate.
Subject Enrolment Control Arm: Children of age as defined by inclusion criteria will be identified from a list of registered children with the Lady Health Worker (nearest record possible). The sample will be stratified by the same age groups as described for the intervention group.
Experimental Arm: A list of children meeting the inclusion criteria was available from the LHW. Any additional child will be verified with the respective LHW prior to enrolment. Enrolment for children in experimental group is defined as child having registered and attended at least 3 days of preschool in week 1.
Data Collection Instruments All instruments were developed in English in the first instance and then translated to Sindhi (with back translations) and piloted prior to use in the study. A systematic adaptation protocol was followed.
Quality Assurance The following strategies are being used
- A 10% sample of assessments are being observed by the field supervisor and scored simultaneously for inter-rater agreement. This shall be followed by a feedback session with the assessor.
- Daily debriefing meetings are held where challenges and solutions will be discussed and will also be used as an opportunity for learning.
- A 10% sample of classroom observations are being video recorded for coding by experts.
- Anthropometry equipment is calibrated daily.
Data Management Forms are being checked prior to entry. The data entry softwares include checks to minimize errors. Data entry is being done at the data entry office located at the field office. All forms are being data entered. A weekly report on status of data entry is being shared by the data entry office.
Data Analysis Plan: An intention to treat model.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preschool | Experimental | Behavioral: Community-based Preschool* This arm will receive the community-based preschool intervention. * The preschool sessions will include 2 groups per day (3 years 6months to 4 years 6 months in the morning session and 4 years 7 months to 5 year 6 months in the afternoon session at the time of enrolment) * Each session will last 3 hours for 5 days per week. * The expected CYL-to-child ratio will be 1:15; however, given the expected high level of local demand it may exceed to a maximum of 1:20 ratio. |
| Control | No intervention | –The control group will receive standard services available in the community. |
Who may qualify
- Ages
- 42 to 66 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Resident of study cluster
- Not enrolled in a preschool
Key exclusion criteria (1 listed)
- Obvious disability
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 |
|---|---|---|
| Community-based Preschool* Preschool sessions in community-based preschool * Run by trained community youth leaders from the same village. | Behavioural | Preschool |
Primary outcome
School readiness as defined by the percentage of items passed on a measure of school readiness.
Time frame: After a minimum of 6 months of intervention exposure.
Cognitive, social-emotional, motor, early literacy and early numeracy
Child executive functioning tasks composite score
Time frame: After a minimum of 6 months of intervention exposure
Inhibitory control, cognitive flexibility, working memory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2016.
- Derived from this study: PubMed 30566498Yousafzai AK, Rasheed MA, Rizvi A, Shaheen F, Ponguta LA, Reyes CR. Effectiveness of a youth-led early childhood care and education programme in rural Pakistan: A cluster-randomised controlled trial. PLoS One. 2018 Dec 19;13(12):e0208335. doi: 10.1371/journal.pone.0208335. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Aisha K Yousafzai, PhD principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Community-based Preschool in people with Child Development, run by Aga Khan University at 1 site in Pakistan.
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 1 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 1 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Muneera A Rasheed, MS (009234864334 ext. 4334, muneera.rasheed@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
School readiness as defined by the percentage of items passed on a measure of school readiness. (time frame: After a minimum of 6 months of intervention exposure.). 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 NCT02645162, 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 1 Jan 2016.