NCT02645162

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

January 1, 2016

Status Verified

December 1, 2015

Enrollment Period

9 months

First QC Date

December 31, 2015

Last Update Submit

December 31, 2015

Conditions

Keywords

PakistanEarly Child Development, Care and EducationYouth Leaders

Outcome Measures

Primary Outcomes (2)

  • 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

    After a minimum of 6 months of intervention exposure.

  • Child executive functioning tasks composite score

    Inhibitory control, cognitive flexibility, working memory

    After a minimum of 6 months of intervention exposure

Other Outcomes (1)

  • Knowledge and Practice for Health, Hygiene and Nutrition

    After a minimum of 6 months of intervention exposure

Study Arms (2)

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.

Behavioral: Community-based Preschool

Control

NO INTERVENTION

The control group will receive standard services available in the community.

Interventions

* Preschool sessions in community-based preschool * Run by trained community youth leaders from the same village.

Preschool

Eligibility Criteria

Age42 Months - 66 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Resident of study cluster
  • Not enrolled in a preschool

You may not qualify if:

  • Obvious disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

RECRUITING

Related Publications (1)

  • 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.

Study Officials

  • Aisha K Yousafzai, PhD

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muneera A Rasheed, MS

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 31, 2015

First Posted

January 1, 2016

Study Start

December 1, 2015

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

January 1, 2016

Record last verified: 2015-12

Locations