Glasses in classes: A cluster-randomised controlled trial to evaluate the effects of a school-based intervention to improve academic, social and emotional learning, visual acuity, and adherence to glasses wear in young children in a disadvantaged multi-ethnic community

ISRCTN ISRCTN23508254
DOI https://doi.org/10.1186/ISRCTN23508254
IRAS number 253681
Secondary identifying numbers IRAS 253681; CPMS 41579
Submission date
04/12/2019
Registration date
21/01/2020
Last edited
21/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
In the UK it is recommended that all children receive an eyesight test in their Reception year. This is provided by health services and results are shared with families, but not schools. Roughly 10–15% of children fail their eyesight test, and of these around a third are not taken to the opticians to obtain glasses.
This project will test an intervention designed to increase the number of children who obtain and consistently wear glasses, following the eye test. The results of the eye test will be shared with schools, school staff will be trained to support pupils and their families to get glasses and encourage pupils to wear them, and funding will be provided for a second pair of glasses for pupils to keep at school.

Who can participate?
Children aged 4-5 years of age enrolled in reception year in state-funded primary schools based in the Metropolitan area of Bradford, United Kingdom

What does the study involve?
At the start of the reception year, parents from the treatment and control schools will receive an information letter about the study, with the right to withdraw their children from the study. Children will then receive a vision screening, along with academic pretests. Schools will then be randomly assigned to conditions. Vision screening results will be revealed (Pass/Fail) and letters will be sent to parents with instructions to go to the optician (this applies to both intervention and control groups); if they attend the appointment, they will receive a pair of home
glasses. For the intervention group only, vision coordinators will be trained (after pretests are completed). If the parents and children attend the appointment at the opticians, a spare pair of glasses will be sent to the school and will be made available in the classroom. The intervention will run for the academic school year, with teachers ensuring children prescribed glasses wear them, and that their spare pair are available if they attend school without their home pair, as well as working with families to prioritise glasses wear at home. Parents are asked to report to schools if the home glasses are lost or broken and they will be asked to attend the optometrist with their children for the fitting of the replacement glasses. School glasses replacement will be organized by the intervention team, once informed by the school. Number of replacement glasses will be monitored by the developer.

What are the possible benefits and risks of participating?
Benefits: Children will receive glasses if they are required.
Risks: None expected.

Where is the study run from?
1. Bradford Institute for Health Research, UK
2. Centre for Applied Education Research, UK
3. University of Nottingham, UK

When is the study starting and how long is it expected to run for?
June 2019 to May 2021

Who is funding the study?
Education Endowment Foundation, UK

Who is the main contact?
Prof. Roisin Corcoran
roisin.corcoran@nottingham.ac.uk

https://educationendowmentfoundation.org.uk/projects-and-evaluation/projects/glasses-in-classes/

Study website

Contact information

Prof Roisin Corcoran
Scientific

School of Education
University of Nottingham
Nottingham
NG8 1BB
United Kingdom

ORCiD logoORCID ID 0000-0003-2883-1466
Phone +44 (0)115 951 3709
Email roisin.corcoran@nottingham.ac.uk

Study information

Study designInterventional cluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)School
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleGlasses in classes: A cluster-randomised controlled trial to evaluate the effects of a school-based intervention to improve academic achievement, visual acuity, and adherence to glasses wear in young children in a disadvantaged multi-ethnic community
Study acronymGiC
Study objectives1. What is the impact on the reading achievement (letter-word identification) of pupils in reception classes participating in Glasses in Classes as opposed to participating in a business-as-usual control group?
2. What is the impact on the mathematics and reading achievement (word attack) of pupils in reception classes participating in Glasses in Classes as opposed to participating in a business-as-usual control group?
3. What is the impact of Glasses in Classes in comparison to business-as-usual control group on student mathematics and reading achievement among pupils eligible for FSM (defined as any student who has ever been classified as in receipt of free school meals)?
4. What is the impact on the visual acuity of pupils in reception classes participating in Glasses in Classes as opposed to participating in a business-as-usual control group?
Ethics approval(s)1. Approved 07/05/2019, NHS Bradford Teaching Hospitals Foundation Trust (Health Research Authority,
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, NHSBT Newcastle Blood Donor Centre Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44(0)2071048083; nrescommittee.yorkandhumber-bradfordleeds@nhs.net), ref: 19/YH/0124
2. Approved 08/05/2019, University of Nottingham (School of Education Ethics Committee, Dearing Building, Jubilee Campus, Wollaton Road, Nottingham, NG8 1BB, UK; +44 (0)115 846 8405; educationresearchethics@nottingham.ac.uk), ref: 2019/24
Health condition(s) or problem(s) studiedVision requiring correction
InterventionInterventional cluster randomised controlled trial involving reception year children in primary schools in Bradford. Randomisation is at school-level and target is 100 schools (50 treatment = T; 50 control = C) with each school providing close to full two reception classes of approximately 27 pupils per class . All reception pupils (2019–2020) in both treatment and control schools will undergo vision screening assessment, but only a sub-sample of pupils (~15%) who fail the vision screening assessment will be included in the intention-to-treat (ITT) analysis and contribute to the pre- and posttests. Baseline reading and mathematics achievement for pupils in reception classes will be assessed in autumn 2019, prior random assignment. Posttest will be administered in spring 2020. The ITT sample will include the pupils in reception classes in 2019, who are enrolled in the intervention schools at the point of random assignment. Pupils not enrolled at the point of random assignment are considered joiners. The final analysis sample will exclude the joiners, but they will receive the intervention as usual.

Schools are randomised into treatment and control using simple randomisation.
Intervention typeOther
Primary outcome measureReading achievement measured using Letter-Word Identification sub-scale from the Woodcock-Johnson IV at baseline (autumn 2019) and follow up (Spring 2020)
Secondary outcome measures1. Reading achievement measured using Word Attack sub-scale from the Woodcock-Johnson IV at baseline (autumn 2019) and follow up (Spring 2020)
2. Reading achievement measured using Applied Problems from the Woodcock-Johnson IV at baseline (autumn 2019) and follow up (Spring 2020)
Overall study start date01/12/2018
Completion date31/05/2021

Eligibility

Participant type(s)Other
Age groupChild
Lower age limit4 Years
Upper age limit5 Years
SexBoth
Target number of participants700 students in 100 schools
Key inclusion criteria1. Children aged 4-5 years of age
2. Enrolled in reception year in state-funded primary schools based in the Metropolitan area of Bradford, United Kingdom
Key exclusion criteriaJoiners (children who joined the class after the start of the study)
Date of first enrolment01/06/2019
Date of final enrolment31/08/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Centre for Applied Education Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
University of Nottingham
School of Education
Jubilee Campus
Wollaton Road
Nottingham
NG81BB
United Kingdom

Sponsor information

Education Endowment Foundation
Charity

9th Floor
Millbank Tower
21-24 Millbank
London
SW1P 4QP
United Kingdom

Phone +44 (0)207 802 1676
Email info@eefoundation.org.uk
Website https://educationendowmentfoundation.org.uk

Funders

Funder type

Charity

Education Endowment Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
EducEndowFoundn, Education Endowment Foundation | London, EEF
Location
United Kingdom

Results and Publications

Intention to publish date31/05/2021
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryStored in repository
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 30/09/2019 21/01/2020 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN23508254_Protocol_30Sep2019.pdf
uploaded 21/01/2020

Editorial Notes

21/01/2020: The protocol (not peer reviewed) has been uploaded as an additional file.
12/12/2019: Trial’s existence confirmed by University of Nottingham