Ignite Creation Date:
2024-05-06 @ 7:35 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06065631
Status:
RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-09-21
Brief Title:
Seeing to Learn in Sierra Leone
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Seeing to Learn in Sierra Leone Impact of Spectacle Correction on Childrens Academic Performance and Mental Health Wellbeing
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLII
Brief Summary:
The main objective of the Sierra Leone Sees to Learn SL2 trial is to assess the educational impact of providing free eyeglasses to students aged 12-15 years with uncorrected refractive error in Sierra Leone The procedures include baseline questionnaires and educational assessments to collect data on students and schools and then the provision of free eyeglasses to students who have uncorrected or undercorrected refractive error URE The questionnaires and student assessments will take 1-2 hours The duration of the study timeframe is one school year The end-line questionnaires and student assessments will be administered at the end of the school year
Detailed Description:
Objective The main objective of the Sierra Leone Sees to Learn SL2 trial is to assess the educational impact of providing free eyeglasses to students aged 12-15 years with uncorrected refractive error in Sierra Leone
Sample frame Approximately 2400 children with uncorrected or undercorrected refractive error URE at 160 randomly-selected schools in Freetown and Bo City A similar number of children from the same schools but without vision problems will also be included at baseline only to compare their basic demographic characteristics and daily activities to those of the children with URE The sample size may vary depending on the percentage of children with URE obtained from screening a total of 40000 children All children with URE as specified in the enrolment criteria below will be part of the study
Design Cluster-randomized control trial cluster RCT with schools as clusters
Randomization interventions and balancing All eligible children will be randomized by school to receive at the start of the school year either free ready-made or custom eyeglasses Intervention or an eyeglasses prescription and letter to parents with free eyeglasses at end-line Control The clusters schools will be stratified into groups based on the prevalence of refractive error and on the score on the baseline mathematics and reading exams The division of the sample into schools in the two cities Bo and Freetown will be in the same proportion as the proportion of the number of public schools in those two cities
Power calculations reading and math exams Setting power 08 statistical precision 005 intracluster correlation 02 from 2019 Sierra Leone grade 8 learning assessment 80 treated schools 80 control schools 15 studentsschool with uncorrected error yields the following minimal detectable effect MDE sizes as a function of correlation between baseline and end-line tests
MDE Correlation of baseline and end-line tests 0101 07 0127 06 0148 05
A nested focus-group study will explore childrens parents and teachers attitudes towards vision student learning and wearing of eyeglasses in order to design a locally-tailored intervention to promote wearing of eyeglasses
Regression Framework
The investigators will estimate the effect of the program using a single difference cross-sectional ordinary least squares regression OLS and a difference-in-difference DID OLS regression that includes observations at both end-line and baseline The investigators will report two types of effects the intent-to-treat ITT effects and local average treatment effects LATE using treatment assignment as an instrumental variable for participation Analysis will use the observed baseline characteristics as control variables and account for school-level variation through a fixed effect
Sample frame Approximately 2400 children with uncorrected or undercorrected refractive error URE at 160 randomly-selected schools in Freetown and Bo City A similar number of children from the same schools but without vision problems will also be included at baseline only to compare their basic demographic characteristics and daily activities to those of the children with URE The sample size may vary depending on the percentage of children with URE obtained from screening a total of 40000 children All children with URE as specified in the enrolment criteria below will be part of the study
Design Cluster-randomized control trial cluster RCT with schools as clusters
Randomization interventions and balancing All eligible children will be randomized by school to receive at the start of the school year either free ready-made or custom eyeglasses Intervention or an eyeglasses prescription and letter to parents with free eyeglasses at end-line Control The clusters schools will be stratified into groups based on the prevalence of refractive error and on the score on the baseline mathematics and reading exams The division of the sample into schools in the two cities Bo and Freetown will be in the same proportion as the proportion of the number of public schools in those two cities
Power calculations reading and math exams Setting power 08 statistical precision 005 intracluster correlation 02 from 2019 Sierra Leone grade 8 learning assessment 80 treated schools 80 control schools 15 studentsschool with uncorrected error yields the following minimal detectable effect MDE sizes as a function of correlation between baseline and end-line tests
MDE Correlation of baseline and end-line tests 0101 07 0127 06 0148 05
A nested focus-group study will explore childrens parents and teachers attitudes towards vision student learning and wearing of eyeglasses in order to design a locally-tailored intervention to promote wearing of eyeglasses
Regression Framework
The investigators will estimate the effect of the program using a single difference cross-sectional ordinary least squares regression OLS and a difference-in-difference DID OLS regression that includes observations at both end-line and baseline The investigators will report two types of effects the intent-to-treat ITT effects and local average treatment effects LATE using treatment assignment as an instrumental variable for participation Analysis will use the observed baseline characteristics as control variables and account for school-level variation through a fixed effect
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None