LEAPS-NCHD Program Evaluation

NCT03764436 | Completed

• 1 other identifier: IRB18-1149
• Study Type: interventional
• Target: 3,858
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Early Child Development; School Readiness; Early Childhood Education; Youth Development

Outcome Measures

Primary Outcomes (1)

• School readiness

  School readiness of children aged 54 - 66 months assessed using the International Development \& Early Learning Assessment (IDELA). IDELA includes domains for emergent math (7 items), socio-emotional development (5 items), self-regulation (1 item), emergent literacy (6 items), fine motor skills (3 items), and gross motor skills (1 item). Total scores are calculated for each domain, and a total IDELA score for school readiness is generated from the domain scores. Higher scores reflect better outcomes.

  Up to 31 months

Secondary Outcomes (12)

• Child executive functioning skills: working memory

  Up to 31 months

• Child general executive functioning skills

  Up to 31 months

• Child executive functioning skills: inhibitory control

  Up to 31 months

• Child executive functioning skills: inhibitory control

  Up to 31 months

• Child executive functioning skills: cognitive flexibility

  Up to 31 months

Study Arms (3)

LEAPS-NCHD Program - Group 1

EXPERIMENTAL

Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.

Behavioral: LEAPS-NCHD Program

LEAPS-NCHD Program - Group 2

EXPERIMENTAL

Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.

Behavioral: LEAPS-NCHD Program

LEAPS-NCHD Program - Group 3

EXPERIMENTAL

Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.

Behavioral: LEAPS-NCHD Program

Interventions

LEAPS-NCHD Program BEHAVIORAL

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.

LEAPS-NCHD Program - Group 1; LEAPS-NCHD Program - Group 2; LEAPS-NCHD Program - Group 3

Eligibility Criteria

• Age: 54 Months - 66 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Resides in the targeted villages
• Aged 54 - 66 months
• Child's primary caregiver must provide both i) informed consent for the caregiver's own participation in the study and ii) permission for the child's participation in the study.
• Child must provide assent for participation in the study.

You may not qualify if:

• Child shows signs of severe clinical health condition or disability.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead
• Aga Khan University: collaborator
• Yale University: collaborator
• Swiss Tropical & Public Health Institute: collaborator
• Dubai Cares: collaborator
• Grand Challenges Canada: collaborator

Study Sites (1)

Aga Khan University Naushahro Feroze Office

Naushahro Fīroz, Sindh, Pakistan

Location

Related Publications (7)

• Arnold C, Bartlett K, Gowani S, Merali R. Is everybody ready? Readiness, transitions and continuity- reflections and moving forward. Working Papers in Early Childhood Development No. 41. The Netherlands: Bernard van Leer Foundation, 2007.

  BACKGROUND

• UNICEF Pakistan. Out of school children in the Baluchistan, Khyber Pakhtunkhwa, Punjab and Sindh provinces of Pakistan. Islamabad: UNICEF, 2013.

  BACKGROUND

• Aga Khan Foundation. Learning about Learning: Reflections on Studies from 10 Countries. Aga Khan Foundation, Geneva, Switzerland, 2013.

  BACKGROUND

• Alsager A, Franchett E, Siyal S, Bhamani S, Yousafzai AK, Sudfeld CR. Household Food Insecurity, Growth and Development of Preschool Children: Evidence From Rural Pakistan. Matern Child Nutr. 2025 Oct;21(4):e70062. doi: 10.1111/mcn.70062. Epub 2025 Jul 7.

  PMID: 40621881 DERIVED

• Yousafzai AK, Siyal S, Franchett EE, Dai Q, Rehmani K, Sudfeld CR, Bhamani S, Hakro S, Reyes CR, Fink G, Ponguta LA. 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. Lancet Child Adolesc Health. 2025 Jan;9(1):25-36. doi: 10.1016/S2352-4642(24)00304-3. Epub 2024 Dec 2.

  PMID: 39637878 DERIVED

• Ali NB, Yousafzai AK, Siyal S, Bhamani S, Sudfeld CR. 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. J Nutr. 2024 Feb;154(2):755-764. doi: 10.1016/j.tjnut.2023.12.008. Epub 2023 Dec 9.

  PMID: 38072156 DERIVED

• Yousafzai AK, Sudfeld CR, Franchett EE, Siyal S, Rehmani K, Bhamani S, Dai Q, Reyes CR, Fink G, Ponguta LA. Evaluating implementation of LEAPS, a youth-led early childhood care and education intervention in rural Pakistan: protocol for a stepped wedge cluster-randomized trial. Trials. 2021 Aug 17;22(1):542. doi: 10.1186/s13063-021-05518-9.

  PMID: 34404454 DERIVED

Study Officials

• Aisha K Yousafzai, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

• Shelina Bhamani, PhD

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Global Health

Model Details: This study uses a cluster-randomized stepped-wedge design with three steps to evaluate the impact of LEAPS-NCHD program. Ninety-nine clusters (villages) are enrolled. Thirty-three clusters per step are randomly selected to cross-over from receipt of standard services (comparison) to receipt of the LEAPS-NCHD program (intervention). Unit of randomization is at the village (cluster) level. A process evaluation will assess program rollout for fidelity, adherence, quality, and cost.

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2019
• Primary Completion: May 31, 2021
• Study Completion: June 30, 2021
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Shared within 1 year of the end of the project; stored indefinitely on Harvard Dataverse.

Locations

PA (1)