Language disorder Mental and Behavioural Disorders Developmental disorder of speech and language, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children must be in Reception class 2. Children must be aged 4 to 5 years at pretest 3. Children will be selected for having language weaknesses in comparison to their peers at school entry
Exclusion criteria
Exclusion criteria: 1. Children will be excluded if they have a significant visual impairment 2. Children will be excluded if they have a significant auditory impairment 3. Children will be excluded if they have significant behavioural difficulties, such that they would not be able to take part small group activities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure: The main trial analysis will be conducted by RAND using multilevel structural equation modelling (SEM) to account for the hierarchical nature of the study data and cluster-randomisation. The primary outcome will be a latent language variable created from the four individually administered language tests ((i) CELF recalling sentences subtest, (ii) CELF expressive vocabulary subtest, Renfrew Action Picture test ((iii) information and (iv) grammar). Analyses will be based on this latent outcome variable. The same language latent variable will be created for pretest and posttest scores by the RAND team. In the main analysis model, the pretest latent variable will be the covariate, and the posttest latent variable the outcome measure. The analyses will also be undertaken on each subscale used to create the latent variable. The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means for a group dummy variable comparing pupils in treatment and control schools. Both primary and secondary outcomes will be measured at pretest (baseline) in September/October 2018 and at posttest (on completion of the 20-week intervention in June/July 2019). The funder is open to conducting a longer-term (30-week) follow-up but that has not yet been confirmed. A secondary analysis will be undertaken that follows the EEF’s stated preference for using multilevel modelling for clustered designs that uses a predicted outcome based on the SEM (EEF, 2018). Previous primary outcome measure: Analyses will be based on latent variable ANCOVA models implemented in an SEM framework. The primary outcome will be a language latent variable defined by loadings from the individually administered language tests (CELF recalling sentences subtest, CELF expressive vocabulary subtest, Renfrew Action Picture test (information and grammar). The same language latent variable will be created for pretest and posttest scores. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures: The secondary outcome will be a language latent variable defined by loadings from the ATLAS language app subtests (expressive vocabulary, receptive vocabulary, sentence repetition, listening comprehension). The analysis plan for this secondary analysis is identical to that for the primary outcome. The study will also evaluate any changes in word reading scores from the EWR test by using multilevel modelling on a latent variable from this test. Both primary and secondary outcomes will be measured at pretest (baseline) in September 2018 and at posttest (on completion of the 20-week intervention in June/July 2019). Previous secondary outcome measures: The secondary outcome will be a language latent variable defined by loadings from the ATLAS language app subtests (expressive vocabulary, receptive vocabulary, sentence repetition, listening comprehension). The analysis plan for this secondary analysis is identical to that for the primary outcome. We will also evaluate any changes in word reading scores from the EWR test by using ANCOVA on a latent variable from this test. The effects of clustering within schools will be accounted for in all analyses by using robust (Huber-White) cluster standard errors. Both primary and secondary outcomes will be measured at pretest (baseline) in September 2018 and at posttest (on completion of the 20-week intervention in June/July 2019). | — |
Countries
United Kingdom