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LEAPS-NCHD Program Evaluation

P

President and Fellows of Harvard College

Status

Completed

Conditions

Child Development

Treatments

Behavioral: LEAPS-NCHD Program

Study type

Interventional

Funder types

Other

Identifiers

NCT03764436
IRB18-1149

Details and patient eligibility

About

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.

Enrollment

3,858 patients

Sex

All

Ages

54 to 66 months old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

3,858 participants in 3 patient groups

LEAPS-NCHD Program - Group 1
Experimental group
Description:
Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Treatment:
Behavioral: LEAPS-NCHD Program
LEAPS-NCHD Program - Group 2
Experimental group
Description:
Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Treatment:
Behavioral: LEAPS-NCHD Program
LEAPS-NCHD Program - Group 3
Experimental group
Description:
Participants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Treatment:
Behavioral: LEAPS-NCHD Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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