Is it feasible to conduct a trial of a new intervention to help children with cerebral visual impairment (CVI)?

The CVI Project Feasibility study for a cluster randomised trial of a new intervention to improve outcomes for primary school children at risk of cerebral visual impairments (CVIs), with nested health economic analysis and process evaluation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13762177

Enrollment

3840

Registered

2019-10-04

Start date

2019-10-07

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral visual impairments in primary school children Nervous System Diseases

Interventions

The study intervention is a multilevel package for schools designed to: 1. Increase the knowledge about CVI for schools, teachers and learning support assistants (LSAs) 2. Provide a “tool kit” of adv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Children in state-maintained primary schools, in Y3-Y5, in the Local Authority areas of Taunton, Southampton or Gloucester- in 2019/2020 school year

Exclusion criteria

Exclusion criteria: Children in Reception, Y1, Y2, and Y6

Design outcomes

Primary

Measure	Time frame
1. Recruitment - measured as N of schools recruited and as a proportion of those invited 2. Attrition rate - measured as numbers of schools who are recruited and then drop out 3. Non-agreement to data sharing - measured as numbers of parents who decline to share their children's data 4. Acceptability of intervention - ascertained in interviews with school staff and parents 5. Feasibility of intervention - measured as numbers of staff accessing the intervention material; numbers and type of changes made within the school as reported by teachers in interviews; numbers of children referred to local eye unit for an eye check	—

Measure

Time frame

1. Recruitment - measured as N of schools recruited and as a proportion of those invited 2. Attrition rate - measured as numbers of schools who are recruited and then drop out 3. Non-agreement to data sharing - measured as numbers of parents who decline to share their children's data 4. Acceptability of intervention - ascertained in interviews with school staff and parents 5. Feasibility of intervention - measured as numbers of staff accessing the intervention material; numbers and type of changes made within the school as reported by teachers in interviews; numbers of children referred to local eye unit for an eye check

—

Secondary

Measure	Time frame
At baseline and 12-months: 1. Child's self-reported Quality of Life (QoL) using the Generic core scales of the PedsQL 2. Teacher-report of the child's Cognitive abilities using the PedsQL Cognitive Functioning scales 3. Teacher report of the child's behaviour using the Strengths and Difficulties (SDQ) questionnaire with Impact supplement 4. Parent report of the child's behaviour using the SDQ Impact supplement 5. Parent report of child-related Family life using the PedsQL Family Impact Module 6. Parent-report of child-related costs using a bespoke Health Economics form	—

Measure

Time frame

At baseline and 12-months: 1. Child's self-reported Quality of Life (QoL) using the Generic core scales of the PedsQL 2. Teacher-report of the child's Cognitive abilities using the PedsQL Cognitive Functioning scales 3. Teacher report of the child's behaviour using the Strengths and Difficulties (SDQ) questionnaire with Impact supplement 4. Parent report of the child's behaviour using the SDQ Impact supplement 5. Parent report of child-related Family life using the PedsQL Family Impact Module 6. Parent-report of child-related costs using a bespoke Health Economics form

—

Countries

England, United Kingdom

Contacts

Public ContactCathy Williams

cvi-project@bristol.ac.uk+44 (0)117 428 3152

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026