Children with social communication impairments Mental and Behavioural Disorders
Conditions
Interventions
Participating children with social communication impairment will be cluster randomised, with randomisation at the level of their treating speech and language therapist. Speech and language therapists
Sponsors
North East London Foundation NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: SLTs will review their caseloads and identify suitable children aged 4 – 7 years using the Social Communication Behaviour Checklist devised by Adams et al (2012): 1. The child has trouble understanding and interpreting the social context and friendship, e.g. social roles, emotions 2. The child has trouble understanding and/or using non-verbal aspects of communication, e.g. facial expression, intonation 3. The child has trouble with aspects of conversation, e.g. beginning and ending, taking turns, giving relevant and sufficient information 4. The child makes bizarre, tangential or inappropriate comments 5. The child has difficulty using and understanding non-literal language Children are required to meet two out of the five criteria above
Exclusion criteria
Exclusion criteria: Hearing, visual or physical impairment severely affecting speech production
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to establish the feasibility of a future definitive randomised controlled trial. The main outcome (i.e., evaluation of effectiveness of E-PLAYS) will not be determined in this feasibility trial but left to a subsequent main trial. Assessment of feasibility outcomes will inform whether progression to a full-scale trial is viable and will indicate any necessary adjustments (changes to procedures, outcome measures, data collection methods, intervention delivery etc). This study has the following feasibility objectives to assess: 1. Whether sufficient numbers can be recruited (via NHS trusts and schools) and retained for a future trial, considering participation, dropout and completion rates 2. The acceptability of E-PLAYS to children, speech and language therapists, teachers, parents and teaching assistants through participation rates and qualitative methods 3. Treatment fidelity through quantitative and qualitative assessments 4. The suitability of outcome measures via response rates and levels of missing data 5. The feasibility of collecting health economic measures and of determining cost-effectiveness for a full trial 6. Parameters required for the identification of the sample size required for a full-scale trial | — |
Secondary
| Measure | Time frame |
|---|---|
| All outcomes will be measured at baseline, immediately post-intervention (15 weeks post-randomisation) and follow-up (35 weeks post-randomisation): 1. Pragmatic language skills will be measured using the Test of Pragmatic Skills (Shulman, 1986) 2. Communication and speech will be measured using the Children's Communication Checklist (Bishop, 2003) 3. Children's classroom behaviours and peer relations will be measured using the Strengths and Difficulties Questionnaire (Goodman, 2005) 4. General formal language and comprehension will be measured using the Clinical Evaluation of Language Fundamentals (Celf-5) Recalling Sentences subscale (Semel, Wiig & Secord, 2017) 5. Qualitative observations of the children's interactions in a non-computerised collaborative construction task and of the teaching assistants' delivery of E-PLAYS and children's participation 6. Focus groups, interviews and a short bespoke questionnaire will be used to ask speech and language therapists and teaching assistants their opinion of training and of intervention delivery for E-PLAYS 7. Economic outcomes (EQ-5D-5L, PedsQL, and bespoke resource use questionnaires) measured at 35 week follow up | — |
Countries
United Kingdom
Outcome results
None listed