NCT07506603

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

March 26, 2026

Last Update Submit

March 26, 2026

Conditions

Keywords

Preschool accessPreschool InterventionWomen's EmpowermentEducation

Outcome Measures

Primary Outcomes (2)

  • Mean Score International Development and Early Learning Assessment (IDELA)

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

    1 year and 2 years

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

    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.

    1 year and 2 years

Secondary Outcomes (6)

  • Mean Score WPPSI-IV Verbal Comprehension Index (VCI)

    1 year and 2 years

  • Mean Score Preschool Self-Regulation Assessment (PSRA)

    Baseline, 1 year and 2 years

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

    1 year and 2 years

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

    1 year and 2 years

  • Teacher Satisfaction

    1 year and 2 years

  • +1 more secondary outcomes

Study Arms (2)

Pre-Primary 1 (PP1) - 3 year old

EXPERIMENTAL

Children in Tharaka Nithi County in Kenya will attend preschool from the age of 3 years old. The intervention will introduce an enhanced curriculum that was adapted for the Kenyan context and included coaching of preschool teachers as child caretakers.

Behavioral: PP1

Control

NO INTERVENTION

Current early childhood development programming in Kenya which is for children aged 4 years old and above.

Interventions

PP1BEHAVIORAL

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.

Pre-Primary 1 (PP1) - 3 year old

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School system

Tharaka Nithi County, Kenya

Location

Study Officials

  • Konstantinos (Costas) Meghir, PhD

    Yale University

    PRINCIPAL INVESTIGATOR
  • Helen Baker-Henningham, PhD

    Bangor University and University of West Indies

    PRINCIPAL INVESTIGATOR
  • Simon Onywere, PhD

    Kenyatta University

    PRINCIPAL INVESTIGATOR
  • Dorothy Naivasha, PhD

    Tharaka Nithi County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parents and their children aged 2 - 5 years (approximately) at baseline who live in Tharaka Nithi County in Kenya (a predominantly poor population).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2026

First Posted

April 1, 2026

Study Start

December 4, 2023

Primary Completion

December 21, 2025

Study Completion

December 21, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations