Condition category
Eye Diseases
Date applied
04/12/2019
Date assigned
21/01/2020
Last edited
21/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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/

Trial website

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

Contact information

Type

Scientific

Primary contact

Prof Roisin Corcoran

ORCID ID

http://orcid.org/0000-0003-2883-1466

Contact details

School of Education
University of Nottingham
Nottingham
NG8 1BB
United Kingdom
+44 (0)115 951 3709
roisin.corcoran@nottingham.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 253681; CPMS 41579

Study information

Scientific title

Glasses 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

Acronym

GiC

Study hypothesis

1. 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

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

Study design

Interventional cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Vision requiring correction

Intervention

Interventional 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 type

Other

Phase

Drug names

Primary outcome measure

Reading achievement measured using Letter-Word Identification sub-scale from the Woodcock-Johnson IV at baseline (autumn 2019) and follow up (Spring 2020)

Secondary outcome measures

1. 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 trial start date

01/12/2018

Overall trial end date

31/05/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. 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

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

700 students in 100 schools

Participant exclusion criteria

Joiners (children who joined the class after the start of the study)

Recruitment start date

01/06/2019

Recruitment end date

31/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Bradford Institute for Health Research
Temple Bank House Bradford Royal Infirmary Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Centre for Applied Education Research
Temple Bank House Bradford Royal Infirmary Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

University of Nottingham
School of Education Jubilee Campus Wollaton Road
Nottingham
NG81BB
United Kingdom

Sponsor information

Organisation

Education Endowment Foundation

Sponsor details

9th Floor
Millbank Tower
21-24 Millbank
London
SW1P 4QP
United Kingdom
+44 (0)207 802 1676
info@eefoundation.org.uk

Sponsor type

Charity

Website

https://educationendowmentfoundation.org.uk

Funders

Funder type

Charity

Funder name

Education Endowment Foundation

Alternative name(s)

EEF

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository

Intention to publish date

31/05/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

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