Corriger la myopie chez les enfants du secondaire pour augmenter les taux de fréquentation scolaire au secondaire dans les communautés rurales (SWISH)
SWISH (voir bien pour rester à l'école) : essai randomisé de distribution de lunettes aux enfants du secondaire atteints de myopie pour augmenter les taux de fréquentation scolaire au secondaire dans les communautés rurales)
Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already shown in other trials that giving children free glasses leads to better grades and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural China goes on to a regular, non-vocational high school. The investigators would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them.
Study Plan: The investigators will choose 111 middle schools at random in Liaoning, northern China, and all children in Year 1 at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses ("Intervention") or a group getting just glasses prescriptions ("Control.") The main study outcome will be the proportion of children going on to academic (as opposed to vocational) high school, and the study is powered to detect a 10% difference in this figure between groups.The study will also assess whether children wear their glasses at school and how often they use blackboards (which disadvantage short-sighted children) vs textbooks to learn from. These other outcomes will help us to better understand the causal pathway between vision and high school attendance. We will also study the total cost of providing glasses and the teacher support to wear them per additional student attending academic high school, as well as student mental health outcomes. We will also collect data on the progression of nearsightedness. The hypothesis of this study is that providing glasses will increase academic high school attendance.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Research question: Will providing free glasses to myopic rural Chinese students, with a teacher incentive to promote use, increase academic high school attendance?
Design: Cluster-randomised controlled trial
Rationale: Rural Chinese children have high myopia prevalence, but poor access to glasses. Our previous trials show giving free glasses significantly improves academic performance, with greater effect size than parental education or family income, equaling or exceeding other classroom-based medical interventions. Non-vocational (academic) high school attendance is only 30% in rural western China. Strong evidence of educational benefit from glasses is needed to spur adoption of national distribution programs.
Methods: Children in Year 1 at 111 randomly-selected middle schools in Liaoning, Northern China, will be randomized by school to receive free glasses and a trial-proven teacher-based incentive to promote wear (Intervention) or prescriptions only (Control). The main outcome 3 years later will be high school attendance (powered to detect 10% difference between study groups); secondary outcomes of compliance and use of near versus distance classroom learning aids will elucidate biological plausibility of a causal pathway between myopia correction and learning. Local knowledge and attitudes about myopia and spectacle use and intervention cost-effectiveness will be studied.
Statistical methods to be employed in the analysis and justification for the choice of sample size:
Adjusted- and unadjusted-comparison of the difference between study groups
Principal analyses for the main trial will include:
- Of attendance at academic high school after Year 3 of middle school (as opposed to following a vocational pathway or leaving school).
- of observed spectacle wear at un-announced examinations at school and for self-efficacy scores.
- of mental health outcomes after Year 1 year of intervention
Sample size: Assuming 120 students per school undergoing vision screening, 50% of children failing vision screening, 30% of these needing glasses, α=0.05, intra-class correlation=0.10, explained variation by covariates=0.40, difference between the groups in the main study outcome=10%, high-school attendance rate in the Control group=50%, a sample size of 111 middle-schools (55 or 56 in each group) will provide power=80%.
Loss to follow-up in our previous school-based trials in China, SWLW I and II, was approximately 4% over the course of one school year, and so our calculations here assume a loss to follow-up of 10% over 2-3 years. However, we have not adjusted for non-compliance because we will use a strict intention-to-treat analytic approach where children in schools allocated to the Intervention group will be analysed as such irrespective of compliance and because our intention is to test the policy of making free glasses available to those students who need them, rather than the effect of those students actually wearing the glasses. Further, our expected effect size is based conservatively on previous trials with compliance rates of approximately 40%, which we feel can be improved on in the current trial with teacher incentives as above.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Liaoning
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Shenyang, Liaoning, Chine, 110163
- He Eye Specialist Hospital
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Xixia
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Yinchuan, Xixia, Chine, 750021
- Ningxia University
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Northern Ireland
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Belfast, Northern Ireland, Royaume-Uni, BT12 6BJ
- Centre for Public Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Year 1 classes (likely age 12-15 years) at the recruited schools
- Those who will be in the second year of middle school when the intervention begins the next year
- Have uncorrected (without glasses/presenting) visual acuity of ≤6/12 in both eyes
- Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D)
- Visual acuity can be improved to >= 6/7.5 in at least one eye with glasses.
Exclusion Criteria:
- Hyperopia ≥ 2.00 D
- Presence of visually-significant ocular condition besides refractive error
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Intervention
Children at Intervention schools will receive free spectacles of a design they select, based on the child's measured refractive power and dispensed at school by the study optometrist. Additionally, teachers (but not children) in eligible classes will be informed that if 80% spectacle compliance as measured across three separate unannounced inspections was achieved, they will be given an incentive of an conditional cash transfer. The cash transfer will be deposited into the teacher's bank accounts directly. |
Intervention group children in middle school Year 1 will receive spectacles in December 2024. Assuming that the relevant effects of treatment (glasses wear) on the main study outcome are complete once examinations determining high school attendance are finished at the end of Middle School Year 3, Intervention participants will have undergone 32 months (December 2024 - July 2027) of treatment by the endpoint of the trial.
Autres noms:
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Aucune intervention: Control
Children at Control schools will receive a glasses prescription and letter to the parents informing them of the refractive status of their child, with free glasses provided only at the end of the trial. No teacher incentive will be offered. Service offered to the Control group exceeds standard care, in that no school-based programs of vision screening and refraction currently exist in the study area, or in most of rural China. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Academic high school attendance
Délai: In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.
|
Proportion of children who continue to academic high school as opposed to vocational high school or no additional schooling, assessed by systematically contacting parents, teachers and students to ascertain enrolment status |
In July following completion of Year 3 of Middle School. This occurs after 32 months of participant followup.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Compliance with spectacle wear
Délai: After 12 months of participant followup
|
Actual presence of spectacles on the child's face (rather than having glasses at school) at the time of an unannounced examination. |
After 12 months of participant followup
|
|
Blackboard use
Délai: After 12 months of participant followup
|
Frequency of blackboard versus textbook use on a questionnaire administered to class teachers, and answered as "all", "most", "about half", little" or "none" of teaching. |
After 12 months of participant followup
|
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Cost effectiveness of intervention.
Délai: At study closeout, after 32 months of participant followup
|
Calculated as ratio of incremental cost to proportion of children who continue to academic high school as opposed to vocational high school or no schooling. Incremental cost is the difference of costs between implementation of intervention and control. Intervention costs will comprise the screening test, glasses (including replacements) and teacher incentives. |
At study closeout, after 32 months of participant followup
|
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Depression and Anxiety
Délai: At baseline and 12 months post-treatment
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Depression and anxiety score measured with Anxiety Stress Scale (DASS). The score range for depression, anxiety and stress are 0-42, with higher score indicates more severe mental health problems. |
At baseline and 12 months post-treatment
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Self Esteem
Délai: At baseline and 12 months post-treatment
|
Self-esteem score measured with the Rosenberg Self-esteem Scale. The scores range from 0-30, with higher scores indicate higher self-esteem. |
At baseline and 12 months post-treatment
|
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Emotional and behavioral problems
Délai: At baseline and 12 months post-treatment
|
Emotional and behavioral problems score using the Strengths and Difficulties Questionnaire (SDQ), with difficulties score ranges from 0 to 40, Prosocial scale ranges from 0-10, with higher score indicates severe mental health and behavioral problems. |
At baseline and 12 months post-treatment
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Progression of Shortsightedness
Délai: At baseline and 12 months post-treatment
|
Progression of Shortsightedness will be measured using change in refraction over time |
At baseline and 12 months post-treatment
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Parents' and students' attitude towards spectacle wear
Délai: After baseline
|
The primary data collection instruments are two tailored, semi-structured interview guides: one designed for the parents/guardians, and one developmentally adapted for the students. Rather than utilizing rigid survey questions, these qualitative instruments are comprised of open-ended prompts, scenarios. The students interview guide has been specifically adapted for 7th-grade students (aged 12-13). It utilizes age-appropriate terminology and focuses heavily on adolescent-specific barriers, such as peer pressure, cosmetic concerns, and school dynamics. |
After baseline
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nathan Congdon, MD, MPH, Queen's University, Belfast
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MR/S023208/1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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