| 1: Aim |
To understand the acceptability of the BALANCE protocol to families and the feasibility of integrating the study into their daily routine To understand whether children would be willing to use the Nintendo 3DSXL
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| 2: Methods | Two rounds of 1:1 interviews with parents of children (aged 3–8 years) undergoing standard of care treatment for amblyopia recruited via the clinic (eight families). Interviews were conducted with each family in a private space away from the clinic and waiting area. Participants were volunteers. Responses were recorded anonymously:Round 1: up to 30 min interviews with three families about the BALANCE protocol design Round 2: up to 60 min interviews with five families about the usability of the Nintendo 3DSXL (including observation of the children with the device)
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| 3: Results | Round 1:All families were happy for 1 hour of screen time a day; two families preferred 2×30 min sessions Two families prefered monitoring visits every 8 weeks over monthly; one family preferred more frequent monitoring Two families thought it was acceptable to return the device after a proposed 6 month treatment period; whereas one family felt their child would want to keep it
Round 2:All families had negative experiences with patching and said the device would be a welcome alternative if effective All families felt it would be possible to integrate the device into the daily routine for the 2–3 months treatment period and would be willing to extend Three families felt they would need to use incentivisation to help children to concentrate on the device for the treatment period; one family felt young children (3–5 years) would struggle to concentrate All families felt monitoring visits every 8 weeks was acceptable Four families felt their child would be happy to pass the device onto another child at the end of the treatment regimen Four families were in favour of refreshing the content on the device at follow-up visits Three families did not feel the proposed use of the Children Health Utility (CHU9D, Stevens et al)—a paediatric generic preference-based measure of health-related quality of life—was appropriate for the study All children engaged with the device; four children (ages 6–8 years) engaged for the longest (up to 10 mins) while the 3-year-old was less engaged; two children almost deleted the content from the device
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| 4: Discussion and conclusions |
Families were positive about the development of a new treatment approach and favourable of the proposed study and agreed that it would be possible to integrate it into the family routine Families informed feasibility and directly influenced the final design: possibility of 2×30 min sessions; reduced duration of follow-up from monthly to every 8 weeks; to replace CHU9D with a series of follow-up questions asked at monitoring appointments (as suggested by one family) Overall it was felt children could engage with the intervention but younger children in particular might be less engaged; access to the device settings would need to be secured
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| 5: Reflections/critical perspective |
We did not directly involve children in the design of the study. At the time we were advised that children from this age group may not be able to engage cognitively with the study. The team at the time did not have experience of children’s involvement or access to an appropriate children’s and young people’s advisory group (YPAG) to support this work. We have since established a children and young people’s advisory group (Eye YPAG) who can provide support for the future One family in each round did not have English as a first language and appeared to find engagement with the study more difficult, suggesting access to a translator may be required to support study delivery
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