NCT03764436

LEAPS-NCHD Program Evaluation

Completed NA Last updated 9 August 2021

What this trial tests

NA trial testing LEAPS-NCHD Program in Child Development in 3,858 participants. Completed in 30 June 2021.

Timeline

1 January 2019

Primary endpoint
31 May 2021

30 June 2021

Quick facts

Lead sponsor	Harvard School of Public Health (HSPH)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	prevention
Enrollment	3,858
Start date	1 January 2019
Primary completion	31 May 2021
Estimated completion	30 June 2021
Sites	1 location across Pakistan

Drugs / interventions tested

• LEAPS-NCHD Program

Conditions studied

• Child Development — all drugs for Child Development →

Sponsor

Harvard School of Public Health (HSPH)

Who can join

Adults 54 Months to 66 Months, any sex, with Child Development. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Evaluating implementation of LEAPS, a youth-led early childhood care and education intervention in rural Pakistan: protocol for a stepped wedge cluster-randomized trial.
   Yousafzai AK, Sudfeld CR, Franchett EE, Siyal S, et al · · 2021 · cited 4× · PMID 34404454 · DOI 10.1186/s13063-021-05518-9
2. Effect of a youth-led early childhood care and education programme on children's development and learning in rural Sindh, Pakistan (LEAPS): a stepped-wedge cluster-randomised implementation trial.
   Yousafzai AK, Siyal S, Franchett EE, Dai Q, et al · · 2025 · cited 1× · PMID 39637878 · DOI 10.1016/s2352-4642(24)00304-3
3. Household Food Insecurity, Growth and Development of Preschool Children: Evidence From Rural Pakistan.
   Alsager A, Franchett E, Siyal S, Bhamani S, et al · · 2025 · PMID 40621881 · DOI 10.1111/mcn.70062
4. Effect of a Center-Based Early Childhood Care and Education Program on Child Nutritional Status: A Secondary Analysis of a Stepped-Wedge Cluster Randomized Controlled Trial in Rural Sindh, Pakistan.
   Ali NB, Yousafzai AK, Siyal S, Bhamani S, et al · · 2024 · PMID 38072156 · DOI 10.1016/j.tjnut.2023.12.008
5. Effect of a Youth Led Early Childhood Care and Education Programme on Children's Development and Learning: A Stepped-Wedge Cluster-Randomised Implementation Trial in Rural Sindh, Pakistan
   Yousafzai A, Siyal S, Franchett E, Dai Q, et al · · 2022 · DOI 10.2139/ssrn.4066422
6. Evaluating implementation of LEAPS, a youth-led early childhood care and education intervention in rural Pakistan: protocol for a stepped-wedge cluster randomized trial
   Yousafzai AK, Sudfeld CR, Franchett EE, Siyal S, et al · · 2021 · DOI 10.1101/2021.04.15.21255571