 was supervised by the research team. This represents an ‘ideal’ scenario for intervention and it is likely that results would differ from implementation in ‘real-life’ by professionals who would not have the benefit of intensive supervision, time and training. Successful implementation by the National Health Service (NHS) speech and language teams throughout the UK would require the E-PLAYS intervention to translate to a setting in which speech and language therapists and teaching assistants could learn to use it together without research team input or supervision.
Following on from our preliminary work with E-PLAYS [29, 39] therefore, the aim of the present study is to establish the feasibility of running a full-scale clinical trial to evaluate its clinical- and cost-effectiveness when implemented within the National Health Service (NHS) in the UK. Speech and language therapists are employed by and work within the NHS, but their day to day work frequently takes place in the school setting, rather than in clinics, particularly for young children.
This feasibility study will explore potential challenges and aim to develop a protocol for a follow-on large-scale RCT. Specific objectives include testing the recruitment procedure and recording the number of participants recruited over time. An important aspect will focus on determining treatment fidelity; E-PLAYS will be delivered by teaching assistants who have been trained by NHS speech and language therapists. We will also aim to establish the acceptability of E-PLAYS with speech and language therapists and with teachers, teaching assistants, parents and children and also explore the acceptability of randomisation to a control group. We will also seek to determine the feasibility of collecting resource-use data and quality of life measures for the purpose of calculating relative cost-effectiveness.
The design is a two-arm feasibility cluster-randomised controlled trial (cRCT) with randomisation at the level of the speech and language therapist (SLT). Each participating child receiving the E-PLAYS intervention will be a child with social communication impairments. For each participating child, there will be an associated teacher and parent who will complete questionnaires, a speech and language therapist and teaching assistant who will deliver the intervention and a typically developing child from the same class who will partner the child to play the E-PLAYS game. For ease of reference, these will be called ‘participant groups’; each participant group comprises one child with communication impairment, plus one parent, one teacher, one SLT, one teaching assistant and one typically developing partner child. The randomisation will occur at the level of the SLT because once an SLT has become familiar with E-PLAYS, it is possible that their approach to children with social communication difficulties may be influenced. Therefore, SLTs will receive immediate training if randomised to the intervention group and if allocated to the control group, will receive training after all study measures have been completed.
Participating children in the intervention arm will receive the E-PLAYS intervention while participating children in the control arm will receive treatment as usual. The trial will be pragmatic in nature with the interventions being delivered in the way that they would be delivered within the NHS. The effectiveness of E-PLAYS will not be addressed in this feasibility trial but left to a subsequent full-scale RCT, with the key outcomes of the present study relating to the feasibility of conducting such an RCT. Assessment of these feasibility outcomes will inform whether a full-scale trial is viable and inform its design and implementation.
We will recruit SLTs and suitable children on their caseloads from within North East London NHS Foundation Trust (NELFT) Speech and Language Services.
Participants will comprise the following in a ‘participant group’ comprising one child with social communication impairment (SCI) with associated relevant others:
SLTs from NELFT
Participat