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Child DevelopmentNCT03764436

LEAPS-NCHD Program Evaluation

A study testing LEAPS-NCHD Program in people with Child Development, run by Harvard School of Public Health (HSPH) at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 54 to 66 monthsHealthy volunteers can take part
Conditions the study is for
Child Development
What is being tested?
LEAPS-NCHD Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,858 participants
Where
1 sitePakistan
Study dates
1 Jan 2019to 30 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 54 to 66 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Aga Khan University Naushahro Feroze Office

    Naushahro Fīroz, Sindh

Other trials in Pakistan

About this study

Official title: Youth Leaders for Early Childhood Assuring Children Are Prepared for School - National Commission for Human Development (LEAPS-NCHD) Program Evaluation

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).

Read more

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.

Being tested
LEAPS-NCHD Program
Keywords
Early Child Development, School Readiness, Early Childhood Education, Youth Development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LEAPS-NCHD ProgramBehavioural

    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.

Study groups in NCT03764436
Study groupRoleWhat they receive
LEAPS-NCHD Program - Group 1ExperimentalParticipants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Receives: Behavioral: LEAPS-NCHD Program
LEAPS-NCHD Program - Group 2ExperimentalParticipants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Receives: Behavioral: LEAPS-NCHD Program
LEAPS-NCHD Program - Group 3ExperimentalParticipants will receive the LEAPS-NCHD Program, a youth-led community-based preschool program for children aged 3.5 - 5 years.
Receives: Behavioral: LEAPS-NCHD Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Up to 31 months

Secondary outcomes (12)

  1. Child executive functioning skills: working memory

    Direct assessment examining working memory capacity among children aged 54 - 66 months using the Corsi Block-tapping Test (Noel, 2009). The child's score reflects the longest sequence for which two block series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range: 0 - 4 points). Higher scores indicate better outcomes.

    Measured: Up to 31 months

  2. Child general executive functioning skills

    The Head Toes Knees Shoulders task (Ponitz et al., 2008) will be used to assess general executive functioning skills among children aged 54 - 66 months. The assessment contains two sections, part one being easier and part two more challenging. Child participants may receive 0 to 20 points for each section. Scores will be presented separately for each section. Higher scores reflect better outcomes.

    Measured: Up to 31 months

  3. Child executive functioning skills: inhibitory control

    Direct assessment examining inhibitory control skills among children aged 54 - 66 months using the Knock and Tap assessment (Molfese et al., 2010). Total score is the sum across 16 items (range: 0-16 points). Higher scores reflect better outcomes.

    Measured: Up to 31 months

  4. Child executive functioning skills: inhibitory control

    Direct assessment examining inhibitory control skills among children aged 54 - 66 months using the Peg Tap assessment (range: 0-16 points) (Molfese et al., 2010). Total score is the sum across 16 items. Higher scores reflect better outcomes.

    Measured: Up to 31 months

  5. Child executive functioning skills: cognitive flexibility

    Direct assessment of cognitive flexibility skills among children aged 54 - 66 months, using the Dimensional Change Card Sort (DCCS) (Carlson, 2005). Participants are requested to sort cards at 3 levels. In the "separated" level, the cards depict a black silhouette shape (e.g., rabbit or boat) on a colored card. Thus, the shape and color dimensions are separated. In the "integrated" level, the shape and color are integrated on the card (i.e., red rabbit and blue boat). During "switch trials," participants must change the dimension being matched. In the "border" level, the integrated pictures from the previous level are used, but half of the cards have borders. Five subscores will be examined: Total number correct trials on the separated level, pre- and post-switch (0-6 points each); total number correct trials on the integrated level, pre- and post-switch (0-6 points each); and total correct on the border version (0-12 points). Higher scores reflect better outcomes.

    Measured: Up to 31 months

  6. Youth executive functioning skills: working memory

    Direct assessment to examine working memory skills of youth using the Backward Word Span task (Davis et al., 1995). The participant's score reflects the longest sequence for which two series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range: 0 - 6 points). Higher scores reflect better outcomes.

    Measured: Up to 31 months

  7. Youth executive functioning skills: working memory

    Direct assessment to examine working memory capacity of youth using the Corsi Block-tapping Test (Kessels et al., 2000). Participants will be administered two tests: a forward and a backward test. A score will be awarded for each test, reflecting the longest sequence for which two series were repeated correctly, plus 0.5 if one longer series was also correctly processed (range for each: 0 - 7 points). Higher scores reflect better outcomes

    Measured: Up to 31 months

  8. Youth executive functioning skills: inhibitory control

    Direct assessment to examine inhibitory control skills of youth using the Number Stroop Effect (Stroop, 1935). Points are summed across 20 items to calculate the overall sum score (range: 0-20 points). Higher scores reflect better outcomes.

    Measured: Up to 31 months

  9. Youth executive functioning skills: cognitive flexibility

    Direct assessment to examine cognitive flexibility skills of youth using the Trail Making Task (TMT) (Lezak, 1995; Reitan \& Wolfson, 1993). Scores reflect the time for completion in seconds, with the maximum time limit being 300 seconds (range: 0-300). Lower scores indicate a better outcome.

    Measured: Up to 31 months

  10. Youth personal and professional development

    Self-reported questionnaire developed for study context which includes items examining aspects of professional and personal development pertaining to autonomy, self-efficacy, self-esteem, professional growth and aspirations. This does not include a standardized scale.

    Measured: Up to 31 months

  11. Youth self-reported depressive symptoms

    Youth self-reported depressive symptoms using the Self Reporting Questionnaire 20-item (SRQ-20). Items are summed for a total score of depressive symptoms over the last 30 days (range: 0 - 20 points). Higher scores reflect poor outcomes.

    Measured: Up to 31 months

  12. Classroom structural and process quality

    Classroom quality assessed using the Measure of Early Learning Environments (MELE) module of the Measuring Early Learning Quality and Outcomes (MELQO) tool.

    Measured: Assessed after program has been running for a minimum of 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2018
  2. Study start1 Jan 2019
  3. Primary completion31 May 2021
  4. Study completion30 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
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.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
3,858 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03764436
Sponsor's protocol ID
IRB18-1149
Status last verified
Aug 2021
First submitted
21 Nov 2018
Last updated
9 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data will be shared on Harvard Dataverse.

Publications

  • 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.

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

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

  • 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.

    PubMed 40621881

  • 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.

    PubMed 39637878

  • 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.

    PubMed 38072156

  • 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.

    PubMed 34404454

Questions about this trial

What is this clinical trial studying?

A study testing LEAPS-NCHD Program in people with Child Development, run by Harvard School of Public Health (HSPH) at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

School readiness (time frame: Up to 31 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03764436, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.

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