ch will follow the guidelines of Braun and Clarke :
(1) Becoming familiar with the data, (2) generating initial codes, (3) searching for themes, (4) reviewing themes and (5) defining and naming themes.
(b) Children’s views on E-PLAYS
Immediately after participating in sessions, children will be asked to rate their enjoyment and use of E-PLAYS using the Fun Toolkit . The tool is easy to complete and requires no writing. It comprises a ‘Smileyometer’ scale; visual analogue scale with ‘smiley’ faces, ‘Fun Sorter’ (children sort which attributes of the game they like best) and ‘Again Again table’ (children rate which aspects of the game they would like to play again). The tool measures, besides user satisfaction, usability (in software terms) and ease of use. The Fun Toolkit has shown good test-retest reliability in previous research . The Smileyometer, Fun Sorter and Again Again table produce numerical data for scoring; however, they are also designed to stimulate and encourage children to talk about the different aspects of the game and their enjoyment.
(c) Fidelity evaluation
(i) Number of intervention sessions
Descriptive statistics will be prepared of the number of intervention sessions completed for each child and their content and duration. The possible impact of treatment fidelity and adherence on outcomes will be explored.
Teaching assistants will be observed by RAs whilst delivering two sessions each to see how they actually deliver E-PLAYS in practice. A crucial aspect of the intervention is the extent to which the instructions in the manual are adhered to. Observers will also record instances of direct verbal feedback and children’s requests for help and comments.
The data from the open-ended questionnaire given to SLTs and teaching assistants will be analysed by coding responses into categories known as a ‘coding frame’ . Given that this is a feasibility study and therefore exploratory in nature, the coding frame will be developed after the data is collected to cover a range of potential responses.
(a) Quantitative measures
It is not intended that this feasibility study will be powered to detect clinical differences between intervention and treatment as usual groups, this is left for the main trial. We are proposing to collect data on outcomes that will be used to inform a future large-scale trial. Sample sizes of between 24 and 70 have been recommended for feasibility trials to allow for the reliable estimation of a standard deviation for use in future sample size calculations [63, 64]. We therefore aim to recruit 70 children (35 in each group). We anticipate that attrition will be low; this is usually the case for school-based studies with young children, e.g. in our pilot study , we lost only one child over a follow-up period of 6 months. However, even with 20% loss to follow-up, we will retain 56 children, which is more than double the recommended minimum sample size. This number will also be sufficient to obtain a reasonably precise estimate of the intra-cluster correlation coefficient for the children grouped by SLT.
(b) Qualitative evaluation
All SLTs and teaching assistants in the intervention group (around seven speech and language therapists and 19 teaching assistants) will receive the open-ended questionnaire. Ten teaching assistants will be observed live delivering E-PLAYS and ten children will give their views using the Fun Toolkit. There will be four focus groups with four to five speech and language therapists or teaching assistants in each group.
The protocol outlined in this article describes a feasibility study for a trial to test an intervention (‘E-PLAYS’) aimed at supporting children with social communication impairments.
E-PLAYS uses novel computer technology to support and stimulate children to improve communication whilst collaborating with their peers. The protocol is based on our earlier pilot studies [29, 39], indicating that the intervention was efficacious when delivered by the research team. Whilst efficacy for E-PLAYS looks promising, it is important to remember that implementation