Clinical trial NCT03764436: LEAPS-NCHD Program Evaluation
Official title: Youth Leaders for Early Childhood Assuring Children Are Prepared for School - National Commission for Human Development (LEAPS-NCHD) Program Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Development
Keywords: Early Child Development
School Readiness
Early Childhood Education
Youth Development
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Aga Khan University
name: Yale University
name: Swiss Tropical & Public Health Institute
name: Dubai Cares
name: Grand Challenges Canada
First posted: 2018-12-05
Enrollment: 3858
Sex: ALL
Minimum age (years): 54
Maximum age (years): 66
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: School readiness
timeFrame: Up to 31 months
Secondary outcomes:
measure: Child executive functioning skills: working memory
timeFrame: Up to 31 months
measure: Child general executive functioning skills
timeFrame: Up to 31 months
measure: Child executive functioning skills: inhibitory control
timeFrame: Up to 31 months
measure: Child executive functioning skills: inhibitory control
timeFrame: Up to 31 months
measure: Child executive functioning skills: cognitive flexibility
timeFrame: Up to 31 months
measure: Youth executive functioning skills: working memory
timeFrame: Up to 31 months
measure: Youth executive functioning skills: working memory
timeFrame: Up to 31 months
measure: Youth executive functioning skills: inhibitory control
timeFrame: Up to 31 months
measure: Youth executive functioning skills: cognitive flexibility
timeFrame: Up to 31 months
measure: Youth personal and professional development
timeFrame: Up to 31 months
measure: Youth self-reported depressive symptoms
timeFrame: Up to 31 months
measure: Classroom structural and process quality
timeFrame: Assessed after program has been running for a minimum of 2 months
Other outcomes:
Locations:
city: Naushahro Fīroz
country: Pakistan
facility: Aga Khan University Naushahro Feroze Office
state: Sindh
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Aisha K Yousafzai, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aga Khan University
name: Shelina Bhamani, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: UNICEF Pakistan. Out of school children in the Baluchistan, Khyber Pakhtunkhwa, Punjab and Sindh provinces of Pakistan. Islamabad: UNICEF, 2013.
citation: Aga Khan Foundation. Learning about Learning: Reflections on Studies from 10 Countries. Aga Khan Foundation, Geneva, Switzerland, 2013.
citation: 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.