LEAPS-NCHD Program Evaluation

NCT03764436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3858

Last updated 2021-08-09

No results posted yet for this study

Summary

An estimated 88 million children drop out of primary school each year worldwide, and the highest number of dropouts are in the first and second grade. A proven strategy to reduce dropout from primary school is participation in early childhood care and education (ECCE) services that bolster young children's health, development and readiness for school. Access to quality ECCE services remains highly limited in Pakistan: less than 50% of four-year-olds are estimated to attend ECCE services, and skilled ECCE workers remain scarce.

To address these challenges, LEAPS (Youth Leaders for Early Childhood Assuring Children are Prepared for School) was developed as a cross-generational strategy to support the learning and development of young children (3.5- to 5.5-year-olds) and female youth (18- to 24-year-olds). The program provides vocational training to female youth, referred to as Community Youth Leaders (CYLs), to deliver a community-based preschool program in rural Sindh, Pakistan. The LEAPS program was previously developed in partnership with Pakistan's National Commission for Human Development (NCHD), a government entity charged with supporting community health, education, and vocational training programs. Efficacy and feasibility of the LEAPS strategy were demonstrated through a prior pilot evaluated in a cluster-randomized controlled trial in 2015 (NCT02645162).

The NCHD is now seeking to integrate the LEAPS program within their full suite of services and to scale the program across 99 villages in rural Sindh under the technical guidance and support of a local implementation support team led by the Aga Khan University. This intervention utilizes two strategies: i) the first is the implementation of the LEAPS program, led by NCHD; and ii) the second is the technical support of the NCHD, to ensure the system is able to support program expansion and sustainability.

This study uses a cluster-randomized stepped-wedge design with three steps to assess program impact on school readiness and child and youth development outcomes across the 99 villages ("clusters"). All clusters will begin in the control state (i.e. access to standard community services). Prior to the start of the trial, clusters will be randomized to 'cross-over' to the intervention state (i.e. introduction of the LEAPS-NCHD program) during one of three sequential steps. Each step will be approximately 9-11 months. By the end of the trial, all clusters will have been exposed to the intervention. Measurement is assessed across all clusters at each step. The total duration of the trial will be 31 months. A process evaluation will also be conducted to examine the large-scale implementation of the LEAPS-NCHD Program.

Conditions

  • Child Development

Interventions

BEHAVIORAL

LEAPS-NCHD Program

The LEAPS-NCHD program trains young women aged 18 - 24 years with a minimum of 10 years of basic education to be preschool teachers, or Community Youth Leaders (CYLs) in community-based preschools in rural Sindh. CYLs will receive two weeks of classroom-based basic-training and 6 months of on-the-job coaching and support. A maximum of 20 children aged 3.5 -5 years old will be enrolled in each preschool. One preschool will be opened per cluster (village). Children will receive a minimum of 6 months of program exposure between assessment rounds.

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER
  • Yale University

    collaborator OTHER
  • Swiss Tropical & Public Health Institute

    collaborator OTHER
  • Dubai Cares

    collaborator OTHER
  • Grand Challenges Canada

    collaborator OTHER
  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Aisha K Yousafzai, PhD · Harvard School of Public Health (HSPH)

  • Shelina Bhamani, PhD · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
54 Months
Max Age
66 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-05-31
Completion
2021-06-30

Countries

  • Pakistan

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764436 on ClinicalTrials.gov