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Completed

NCT Number: NCT07506603

Kenya Preschool Study

This research project aims to design and evaluate an innovative model for childcare provision in rural Kenya that emphasizes child development and economic participation for women in a cost-effective manner. Using a randomized controlled trial (RCT) design, the project will examine the impact of allowing children in Tharaka Nithi County (TNC) in Kenya to attend pre-school from the age of 3 versus the current early childhood development programming in Kenya which is for children aged 4 and above. The potential to offer early childhood development care for 3-year-olds is a key investment to be considered with high potential for expansion across Kenya and beyond. The intervention will introduce an enhanced curriculum for pre-primary 1 (PP1) and will be adapted for the Kenyan context and include coaching of teachers and caregivers. Using a rigorous research design, and by collecting data from both children and parents, the project will capture data on child development, employment, income, intra-household dynamics and broader women empowerment indicators. The project seeks to impact policies aimed at advancing both child development as well as women's economic empowerment in Kenya.

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Key information

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School system

Tharaka Nithi County, Kenya

About this study

The PP1 intervention consists of six main components: A. Expanding admission to 3-year-olds in the current preschools (they currently start at 4), B. Adapting the government curriculum to accommodate the 3-year-old children (as the curriculum currently starts at 4 years) C. Developing teacher activity guides to support curriculum implementation for both 3- and 4-year-olds, D. Providing developmentally appropriate teaching and learning materials (e.g. picture books, puzzles, games), E. Adding an extra teacher in the preschool class (PP1), and F. Training the teachers how to use the activity guides and learning materials and how to use evidence-based and developmentally-appropriate instructional strategies through teacher-training workshops and in-class coaching.

The experimental design involves a Randomized Controlled Trial (RCT) to assess the impact of the Tharaka Nithi County Preschool Program on child development and women's labor supply. The intervention targets 3-4-year-olds, utilizing the existing infrastructure of PP1 (pre-primary 1) in selected public schools.

Participants were recruited in 2 cohorts:

Cohort 1: Randomization will take place by computer following a census of eligible households (those with children 2y8mo-3y6mo at baseline who have expressed willingness to participate) within a radius of 3km from the 118 schools. Within the 3km catchment area of the schools 15 children will be selected and their families consented for the intervention and data collection. Following this, within the catchment group of the 60 treatment schools 5 children are randomly admitted to the treatment schools and another 5 are randomly selected as controls within the same communities. Within the catchment area of the control schools 5 children and their families are randomly selected for observation. Data is collected from the families (mother and father - when present), and the children (assessments) at baseline, midline, and at the end of the intervention. In addition, within each school (treatment and control) 5 4-year olds are recruited. They are also subject to the intervention, since they are in the same classrooms as the 3-year-olds. However, the non-treated 4-year-olds are still attending PP1 class but in a non-treated school.

Cohort 2: The same treatment and control schools are involved. Only 3 year olds are recruited (2y8mo-3y6mo at baseline). Investigators will identify the 5 closest consenting families with 3-year-olds to each of the treatment schools. If it is a treatment school, the 5 children are admitted to the PP1 in that school. The five children and their families in the radius of the control school are kept for observation. Consenting takes place before treatment status is revealed. Data is collected from the families (mother and father - when present), and the children (assessments) at baseline and at the end of the intervention.

Preschool teacher interviews and classroom observations will be conducted after 1 year of intervention and again at the end of the second year of intervention in all study schools.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

School level:

  • schools must offer PP1 classes
  • schools must have sufficient available capacity and some level of infrastructure provision to support an additional 5-8 children (3-year-olds), and
  • should not have more than five 3-year-olds already in attendance of the PP1 class in the year prior to the intervention, nor a playgroup offered by the school

Household/child level:

  • have children who will turn approximately 3 years old by the start of the academic year
  • have demonstrated a willingness to send their children to the local school for the relevant fee.
  • households within a 3 km radius of all eligible schools.

Exclusion criteria

-

Treatment and study plan

PP1

Behavioral

The intervention targets 3-4-year-olds and is using the existing infrastructure of PP1. PP1 is the first part of the pre-primary program, which currently admits only 4-year-old children for one year. Under the proposed intervention, children will attend PP1 starting when they are 3 years old. This curriculum will be enhanced and extended for the broader age range.

Primary outcomes

  1. Mean Score International Development and Early Learning Assessment (IDELA)

    Time frame: 1 year and 2 years

    IDELA is commonly used for program evaluation. Total score range from 0-100% with higher scores indicating better performance.

  2. Mean Score Wechsler Preschool and Primary Scale of Intelligence (WPPSI)- Full Scale IQ (FSIQ)

    Time frame: 1 year and 2 years

    WPPSI assesses cognitive development using engaging, game-like tasks to measure Verbal Comprehension, Visual Spatial, Fluid Reasoning, Working Memory, and Processing Speed. Total score range 40 to 160. Higher scores indicate higher IQ.

Secondary outcomes

  1. Mean Score WPPSI-IV Verbal Comprehension Index (VCI)

    Time frame: 1 year and 2 years

    Measures a child's ability to understand and use language, with scores ranging from 40 to 160. Higher scores indicate better comprehension.

  2. Mean Score Preschool Self-Regulation Assessment (PSRA)

    Time frame: Baseline, 1 year and 2 years

    A tool using direct tasks and an observer-rated scale to evaluate children aged 3-5 on attention, impulse control, and emotional regulation. Score range 0-36 with higher scores indicating better self-regulation.

  3. Mean Score Quality of the Classroom Environment using an adapted version of the Measuring Early Learning Environments (MELE)

    Time frame: 1 year and 2 years

    Includes three subscales: implementation of learning activities, classroom interactions and use of learning materials.

    Focus: Understanding the effectiveness of the intervention in promoting a high quality teaching and learning environment. Scores range from 1-5 with higher scores indicating better environment.

  4. Mean Scores International Development and Early Learning Assessment (IDELA) Subscales

    Time frame: 1 year and 2 years

    IDELA is commonly used for program evaluation. The five subscales: Emergent Literacy, Emergent Numeracy, Socio-Emotional Development, Motor Development and Executive Function. Scores range for each subscale is 0-100% with higher scores indicating better performance.

  5. Teacher Satisfaction

    Time frame: 1 year and 2 years

    Teachers' satisfaction with their workload, work environment, appreciation from parents and social status in the community assessed by self-report. Scores range from 8-40 with higher scores indicating higher satisfaction.

  6. Teacher Burnout

    Time frame: 2 years

    Teacher burnout including subscales on emotional exhaustion and personal accomplishment assessed by self-report. Scores range from 0-54 on emotional exhaustion with higher scores indicating higher exhaustion. Scores range from 0-30 on personal accomplishment with higher scores indicating higher accomplishment.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Gates (Bill and Melinda) Foundation
  • Jameel (Abdul Latif) Poverty Action Lab (J-PAL)
  • Massachusetts Institute of Technology

Registry information

Official study title

A Randomized Evaluation of the Effects of a Preschool Intervention on Child Learning and Female Economic Empowerment in Tharaka Nithi County, Kenya

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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