luster-randomised at the level of the SLTs. SLTs will be randomised 1:1 to receive either immediate briefing from the research team together with the manual on the E-PLAYS intervention or at to receive this at the end of the trial. Randomisation will take place after SLTs have consented to participate in the study, and have identified and recruited children on their caseloads to participate in the trial but before they receive briefing. Allocation will be via minimisation to ensure balance across the two groups based on the borough of the SLT (there are five boroughs within the district covered by NELFT, each served by a different SLT team) and number of children recruited (dichotomised around the median number of children recruited to form a two level factor). All SLTs will be randomised together as opposed to having a rolling recruitment/randomisation period. The minimisation will be implemented by the trial statistician at the York Trials Unit using MinimPy version 0.3. Once the allocations have been generated, they will be communicated to members of the research team responsible for training the SLTs, while ensuring that the outcome assessors (research assistants) remain blind to these allocations.
Parent- and teacher-completed measures cannot be blinded; however, measures collected by research assistants (RAs) will be blinded. Teachers and teaching assistants at the schools will be reminded not to reveal allocations to the research assistants at every visit. For the qualitative data collection (Fun Tool Kit, open-ended training questionnaires, observations and focus groups) in which blinding is not possible, research assistants will not collect data from the same schools in which they are collecting quantitative data in order to preserve blinding.
The SLTs in the intervention group will receive training from the research team and will then, in turn, train teaching assistants in schools to deliver the E-PLAYS intervention to the children. Training for SLTs will be kept to the minimum as the aim of this feasibility study is to explore the feasibility of implementing E-PLAYS within the NHS nationally without research team support. Therefore, SLTs will be introduced to the E-PLAYS game and to the manual only. The SLTs will use a training manual with which to train teaching assistants which covers the delivery of E-PLAYS in depth. They will train teaching assistants for around 1 h.
Quantitative outcome measures
In addition to basic demographic data on age, gender and ethnicity, selected quantitative measures have been chosen for sound psychometric properties (validity, reliability, internal consistency, inter-rater reliability). The specific feasibility outcomes to ascertain recruitment, measure treatment fidelity, test acceptability of both the intervention and of the measures used, and test the feasibility of data collection for language and communication measures, social and mental health measures, generalisation and cost effectiveness for an economic evaluation are given below, with details of the instruments, scales, assessments and interviews to be used:
(a) Recruitment measures
A recruitment log will be kept to determine participation, drop-out and completion rates to inform a possible future full-scale trial.
(b) Language and communication outcome measures
(i) The Children’s Communication Checklist-2, (CCC-2, )
The CCC-2 is the most widely used, standardised questionnaire of communication impairment in research and clinical contexts and will be completed by teachers.
(ii) Test of Pragmatic Skills, (TPS, ).
This is an observational elicitation measure. The tester (RA) engages the child in structured play in which test questions are embedded. The TPS was a sensitive indicator and successful at detecting improvements in communication in our pilot study; it has been standardised on 650+ children by the author. It will be administered by blinded RAs.
(iii) Clinical Evaluation of Language Fundamentals-5 (CELF-5, ).
We will use one of the subscales; recalling sentences. This sentence repetition assessment is a frequentl