None listed
Conditions
Brief summary
Retinoblastoma is the most commonly occurring paediatric eye cancer. The earliest signs of disease include leukocoria (white pupil) and strabismus (crossed eye). Untreated, retinoblastoma results in loss of sight, eye or life. Common strabismus occurs in up to 2-4% of children resulting in poor vision when diagnosed and treated late. Unfortunately, white pupil or strabismus are often ignored as there is a lack of information and misinformation regarding the importance of these signs. Currently, no systematic information is provided to parents in Victoria regarding leukocoria or strabismus. Raising parental awareness of these signs could reduce delays in diagnosis and result in earlier treatment with the potential for improved outcomes. This randomized controlled trial aims to evaluate an evidence-based, theory-informed information pamphlet that has been developed for parents. It is hypothesized that parents who receive the pamphlet would be more alert to these early signs and have heightened help-seeking intentions.
Interventions
The Principal Investigator developed the pamphlet two phases.
Phase 1:
An exploratory qualitative study to identify knowledge gaps and determine factors that influence parents’ help-seeking intentions for ocular symptoms in young children was undertaken. With Human Research Ethics Approval, 18 parents participated in 5 focus groups using photographic prompts of different eye diseases/problems in children. These included: conjunctivitis, swollen eye, white pupil [leukocoria] and turned/crossed
The Principal Investigator developed the pamphlet two phases. Phase 1: An exploratory qualitative study to identify knowledge gaps and determine factors that influence parents’ help-seeking intentions for ocular symptoms in young children was undertaken. With Human Research Ethics Approval, 18 parents participated in 5 focus groups using photographic prompts of different eye diseases/problems in children. These included: conjunctivitis, swollen eye, white pupil [leukocoria] and turned/crossed-eye [strabismus]. Using an inductive thematic analysis approach [Braun & Clarke, 2006], data from the focus groups were then analysed to inform and guide the content of the paediatric eye-health awareness pamphlet for parents. The development of this pamphlet was grounded in an evidence-based approach to develop health promotion materials - ‘Information-Motivation-Behavioural skills’ (IMB) model. {Abraham & Kools, 2012] This theoretical framework specifies that effective health promotion material needs to: address information gaps [information]; provide arguments that motivate behaviour [motivation]; and provide instruction and explanation to perform behaviour [behaviour skills]. Key messages included in the pamphlet addressed the deficits in their knowledge that were identified, messages to motivate action and messages to inform behavioural skills to bring about a change in behaviour. Phase 2: Seventeen cognitive interviews were conducted with women who were either pregnant, had children or were of child-bearing age to review the pamphlet and provide feedback on content, design, layout and comprehension. Following this process, the pamphlet was modified accordingly. The intervention is provided once only for participants randomised to the intervention group at Baseline. Following un-blinding at the conclusion of the study, participants allocated to the control group at Baseline will be provided with the pamphlet to maintain clinical equipoise.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Pregnant women in 2nd or 3rd trimester of pregnancy English-speaking Regular access to email for completion of post-test survey
Exclusion criteria
Cognitive impairment precluding consent to participate for self Non-English speaking No regular access to email for completion of post-test survey
Outcome results
None listed