uantitative 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 in a ‘real-world’ context brings with it a number of challenges not immediately apparent in the closely controlled research setting of a pilot study. Thus, the study described here aims to investigate a number of important feasibility questions before proceeding to a full-scale trial. The context for the implementation of E-PLAYS is the NHS in the UK. NHS treatment for children with social communication disorders is the responsibility of SLTs. SLTs are specialist health professionals and frequently adopt a ‘consultation model’ whereby they provide training for teaching assistants in schools to deliver interventions rather than providing intervention directly themselves . Therefore, E-PLAYS will fit well within typical NHS service delivery if it proves effective when provided via the consultation model and exploring the means of evaluating this is the aim of the present study.
The first aim of the feasibility study is to establish whether sufficient participants can be recruited for a full trial. Recruitment is complex, involving as it does a number of the adults concerned with each child. We will aim to determine whether sufficient numbers of SLTs, children and their parents, teachers and teaching assistants can be recruited and over what period of time for a definitive large-scale RCT.
The second major potential challenge to implementation in the NHS concerns fidelity. E-PLAYS is fully manualised, but is the manual sufficiently clear and comprehensive to ensure faithful delivery? Unlike in our previous pilot studies, should E-PLAYS be distributed nationally, it would not be viable for the research team to train numerous speech and language teams throughout the country. A key research task therefore involves investigating aspects of the indirect delivery whereby training will be provided to teaching assistants by SLTs. This differs fundamentally from delivery by a trained and supervised RA as in our pilot studies and feedback from SLTs and teaching assistants will be crucial.
Other challenges relate more broadly