mic evaluation; we will assess intervention and trial costs only. We will estimate research and implementation costs of undertaking a full trial.
Data collection points for outcome measures
Data collection for the TPS, CCC-2, CELF-5 Recalling Sentences subscale, SDQ and Magformers® construction task will take place at baseline, 15–20 weeks and 35–40 weeks post-randomisation. These time points are equivalent to baseline, immediate post-intervention and 3-month follow-up for the intervention group. All health economic measures will be collected at 35–40 weeks post-randomisation (see Fig. 1. SPIRIT figure for E-PLAYS trial for data collection timings). Data will be collected at three times points from teachers, parents and the children themselves. As we are working with young children who may tire easily, measures will be collected in two to three short (< 30 min) sessions when necessary.
As recommended by the Medical Research Council (MRC) guidance for RCTs , we will supplement quantitative feasibility testing of E-PLAYS with a qualitative process evaluation which will examine the processes involved in intervention delivery. The processes we will explore are: whether instructions for delivery of E-PLAYS are adequate and clear; whether staff in a real-life NHS and school settings can use E-PLAYS faithfully; how acceptable staff find E-PLAYS; and whether children engage with and enjoy E-PLAYS. By conducting this process evaluation, we hope we may identify any possible influencing mechanisms or unintended negative effects not revealed by quantitative measures. In the event that, for example, we fail to recruit to target, or that fidelity appears compromised, the process evaluation may be illuminative. The process evaluation that forms part of this feasibility trial aims to investigate the following processes linked to implementation:
(a) Speech and language therapists’ and teaching assistants’ views
Focus groups with the speech and language therapists and teaching assistants who delivered E-PLAYS will be conducted once delivery is complete, and their views sought on acceptability and ease of use.
(b) Children’s views on E-PLAYS
The children’s view will be solicited using the Fun Toolkit  (which has been designed to measure children’s views of technology) by an RA immediately after each of two sessions.
(c) Fidelity evaluation
On-line recording of the number of intervention sessions completed for each child and their content and duration in minutes will be automatically logged by the E-PLAYS software. For the E-PLAYS computer game, each child will have their own unique login, which will record the number of sessions undertaken, the time that they lasted and which parts of the programme were completed.
E-PLAYS sessions will be observed live by RAs to assess how faithfully teaching assistants actually use it in practice.
We will also explore fidelity issues in the focus groups described above.
(d) Training and instructions
Shortly after receiving the instruction pack and manual, SLTs will be asked to complete a short, open-ended questionnaire giving their impressions of its utility and clarity. Teaching assistants will receive a similar questionnaire after they have received the manual and instruction from SLTs (Fig. 2).
Recruitment data analysis
The number of children recruited and the rate of attrition will be reported by allocation and in total. The number of E-PLAYS sessions completed and their duration will be summarised descriptively for children in the intervention arm.
Analysis of outcome measures
A detailed analysis plan will be produced prior to the final analysis and will be reviewed by the independent trial steering committee. Analyses will follow intention to treat principles, with all data analysed as randomised. Analyses will be entirely descriptive with scores on the TPS, CCC-2, CELF-5 Recalling Sentences Subscale and Magformers® construction task presented unadjusted at each time point.
For the Magformers® construction task, video-recordings will be professionally transcribed and video-coding will comprise obser