- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506603
Kenya Preschool Study
A Randomized Evaluation of the Effects of a Preschool Intervention on Child Learning and Female Economic Empowerment in Tharaka Nithi County, Kenya
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tharaka Nithi County, Kenya
- School system
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pre-Primary 1 (PP1) - 3 year old
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.
|
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.
|
|
No Intervention: Control
Current early childhood development programming in Kenya which is for children aged 4 years old and above.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year and 2 years
|
|
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.
|
1 year and 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
1 year and 2 years
|
|
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.
|
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
|
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. |
1 year and 2 years
|
|
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.
|
1 year and 2 years
|
|
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.
|
1 year and 2 years
|
|
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.
|
2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2000036561
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early Childhood Development
-
Boston UniversityUnited States Agency for International Development (USAID); Swiss Tropical... and other collaboratorsCompletedEarly Childhood DevelopmentZambia
-
Stanford UniversityJohns Hopkins University; University of California, Berkeley; International Centre... and other collaboratorsCompletedEarly Childhood DevelopmentBangladesh
-
Duke UniversityCatholic Relief ServicesCompleted
-
Bartosz M. RadtkeRecruitingChild Development | Infant Development | Early Childhood DevelopmentPoland
-
University of California, BerkeleyUniversity of Nevada, Reno; World BankCompletedEarly Childhood DevelopmentMadagascar
-
Mathematica Policy Research, Inc.The University of Texas Health Science Center, Houston; Department of Health... and other collaboratorsUnknownEarly Childhood Professional DevelopmentUnited States
-
Chang Gung Memorial HospitalActive, not recruitingEarly Childhood Development (ECD)Taiwan
-
University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsNot yet recruiting
-
Mathematica Policy Research, Inc.University of Oklahoma; Department of Health and Human Services; Zero to ThreeUnknownEarly Childhood Professional Development
-
The Hospital for Sick ChildrenCompletedEarly Childhood Development | Self ControlCanada