Seeing to Learn in Sierra Leone: Impact of Spectacle Correction on Children's Academic Performance and Mental Health Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,821
- 试验地点
- 1
- 主要终点
- Prosocial
研究概览
简要总结
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 9-20 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.
详细描述
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 9-20 years with uncorrected refractive error in Sierra Leone.
Sample frame: Approximately 2400 children with uncorrected (or undercorrected) refractive error (URE) at 300 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 40,000 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 = 0.8, statistical precision = 0.05, intracluster correlation = 0.2 (from 2019 Sierra Leone grade 8 learning assessment), 80 treated schools, 80 control schools, 15 students/school with uncorrected error, yields the following minimal detectable effect (MDE) sizes as a function of correlation between baseline and end-line tests:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will be given either glasses or a prescription. Hence, they could not be masked.
The Care Provider, in our case, screening and examination team will be providing either glasses or prescriptions to the participants. Hence, they could not masked.
Investigators and Outcome assessor will only analyse the data at the end of the trial and they will not be
入排标准
- 年龄范围
- 9 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting (with or without glasses) distance visual acuity of 6/12 or worse in the better-seeing eye;
- •Refractive error of at least 0.75 diopters (D) of myopia, 2.00 D of hyperopia or 1.00 D of astigmatism;
- •Visual acuity is correctable to 6/7.5 or better with eyeglasses.
排除标准
- •1. Other ocular problems preventing visual acuity > 6/12 in both eyes.
结局指标
主要结局
Prosocial
时间窗: Month 1 and 9 months after glasses are provided
Measured using Strengths \& Difficulties Questionnaire with the prosocial score ranges from 0 to 10 and higher scores indicate more prosocial behaviour.
Foundational mathematic and literacy skills
时间窗: Month 1 and 9 months after glasses are provided
Item Response Theory to estimate a student's ability on a continuous scale and subsequently standardize students' scores on a continuous scale with respect to the control-group distribution at baseline (mean zero, standard deviation of one). Lower scores will indicate lower performance, and higher scores will indicate higher performance. A -1 would indicate a student's performance is 1 standard deviation below the mean of the control-group performance distribution at baseline. A zero would mean the student performed like the mean student in the control group at baseline.
Anxiety
时间窗: Month 1 and 9 months after glasses are provided
Measured using Generalized Anxiety Disorder 2-item (GAD-2) questionnaire, the highest score is 8 and the lowest score is 2. Higher scores indicated more severe anxiety disorders.
Social and emotional problems
时间窗: Month 1 and 9 months after glasses are provided
Measured using Strengths \& Difficulties Questionnaire with the score ranges from 0 to 40. Higher scores indicate more social and emotional problems.
次要结局
- School attendance(Daily from Month 1 to Month 9)
- Cost-effectiveness 2(Through study completion, an average of 9 months)
- Self-reported wearing of eyeglasses compliance(Month 9 after glasses are provided)
- Enumerator-observed wearing of eyeglasses(At Months 3, 6 and 9 after glasses are provided)
- Teacher-observed wearing of eyeglasses of children(Month 1 to Month 9 after glasses are provided)
- Cost-effectiveness 1(Through study completion, an average of 9 months)