y used measure and is generally regarded as a measure of overall language ability drawing upon a wide range of language processing skills . This will also be administered by blinded RAs.
(c) Social behaviour, friendship and mental health measure
The Strengths and Difficulties Questionnaire
The Strengths and Difficulties Questionnaire (SDQ) is regarded as the ‘gold standard’ measure and is widely used as a mental health indicator with subscales assessing behavioural, emotional and peer problems. This will be completed by teachers .
(d) Measure of generalisation to social contexts
Dyadic collaborative construction task (Magformers®)
A frequently reported issue with interventions targeting children with SCI is that the skills learned do not generalise to contexts beyond those of the intervention. In order to explore whether communication skills learned through E-PLAYS do in fact generalise to other contexts, children will be video-recorded undertaking a typical classroom collaborative task with a peer. The task we will ask the children to complete involves constructing a Magformers® model following a set of video-recorded instructions; this will take around 10 min. Magformers® are plastic, brightly coloured, magnetised blocks (similar in size to Lego® but different in shape and operation) with which it is possible to construct small models (see magformers.co.uk). All children in intervention and control groups will undertake this task and be recorded; children’s use of different kinds of communication will be observed and coded from the video-recording. The Magformers® construction task will be facilitated and video-recorded by blinded RAs who will also undertake coding of the transcripts from the video-recordings.
(e) Health-economic measures
(i) Bespoke Questionnaire
A bespoke questionnaire designed by the team’s health economist based on previous work in studies with children will measure the child’s health services-use (parent-completed, non-blinded).
For the feasibility study, we will not undertake a full economic 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 onc