Early EducationNCT07506603
Kenya Preschool Study
A study testing PP1 in people with Early Education and Early Childhood Development, run by Yale University at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Education, Early Childhood Development
- What is being tested?
- PP1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,017 participants
- Where
- 1 siteKenya
- Study dates
- 4 Dec 2023to 21 Dec 2025
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Evaluation of the Effects of a Preschool Intervention on Child Learning and Female Economic Empowerment in Tharaka Nithi County, Kenya
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.
Read the detailed description
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.
- Conditions
- Early Education, Early Childhood Development
- Being tested
- PP1
- Keywords
- Preschool access, Preschool Intervention, Women's Empowerment, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PP1Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: PP1 |
| Control | No intervention | Current early childhood development programming in Kenya which is for children aged 4 years old and above. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year and 2 years
Secondary outcomes (6)
Mean Score WPPSI-IV Verbal Comprehension Index (VCI)
Measures a child's ability to understand and use language, with scores ranging from 40 to 160. Higher scores indicate better comprehension.
Measured: 1 year and 2 years
Mean Score Preschool Self-Regulation Assessment (PSRA)
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.
Measured: Baseline, 1 year and 2 years
Mean Score Quality of the Classroom Environment using an adapted version of the Measuring Early Learning Environments (MELE)
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.
Measured: 1 year and 2 years
Mean Scores International Development and Early Learning Assessment (IDELA) Subscales
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.
Measured: 1 year and 2 years
Teacher Satisfaction
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.
Measured: 1 year and 2 years
Teacher Burnout
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start4 Dec 2023
- Primary completion21 Dec 2025
- Study completion21 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early EducationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parents and their children aged 2 - 5 years (approximately) at baseline who live in Tharaka Nithi County in Kenya (a predominantly poor population).
- Masking
- None (open label)
- Enrolment
- 2,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Jameel (Abdul Latif) Poverty Action Lab (J-PAL), Massachusetts Institute of Technology, Gates (Bill and Melinda) Foundation
- Responsible party
- Sponsor
- Investigators
- Konstantinos (Costas) Meghir, PhD, Principal investigator, Yale UniversityHelen Baker-Henningham, PhD, Principal investigator, Bangor University and University of West IndiesSimon Onywere, PhD, Principal investigator, Kenyatta UniversityDorothy Naivasha, PhD, Principal investigator, Tharaka Nithi County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506603
- Sponsor's protocol ID
- 2000036561
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Evaluation of the Effects of a Preschool Intervention on Child Learning and Female Economic Empowerment in Tharaka Nithi County, Kenya
- ClinicalTrials.gov ID
- NCT07506603
- Acronym / sponsor ID
- 2000036561
- Conditions
- Early Education, Early Childhood Development
- Keywords
- Preschool access, Preschool Intervention, Women's Empowerment, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,017 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Jameel (Abdul Latif) Poverty Action Lab (J-PAL), Massachusetts Institute of Technology, Gates (Bill and Melinda) Foundation
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 21 Dec 2025 (actual)
- Study completion
- 21 Dec 2025 (actual)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parents and their children aged 2 - 5 years (approximately) at baseline who live in Tharaka Nithi County in Kenya (a predominantly poor population).
| Arm | Type | Receives |
|---|---|---|
| Pre-Primary 1 (PP1) - 3 year old | Experimental | Behavioral: PP1Children 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. |
| Control | No intervention | –Current early childhood development programming in Kenya which is for children aged 4 years old and above. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PP1The 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. | Behavioural | Pre-Primary 1 (PP1) - 3 year old |
Primary outcome
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.
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.
6 secondary outcomes
Mean Score WPPSI-IV Verbal Comprehension Index (VCI)
Time frame: 1 year and 2 years
Mean Score Preschool Self-Regulation Assessment (PSRA)
Time frame: Baseline, 1 year and 2 years
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
Mean Scores International Development and Early Learning Assessment (IDELA) Subscales
Time frame: 1 year and 2 years
Teacher Satisfaction
Time frame: 1 year and 2 years
Teacher Burnout
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konstantinos (Costas) Meghir, PhD principal investigator
Yale University
Helen Baker-Henningham, PhD principal investigator
Bangor University and University of West Indies
Simon Onywere, PhD principal investigator
Kenyatta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PP1 in people with Early Education and Early Childhood Development, run by Yale University at 1 site in Kenya.
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 8 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 1 Apr 2026. 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 Kenya. 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?
Mean Score International Development and Early Learning Assessment (IDELA) (time frame: 1 year and 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.