RESUMO
BACKGROUND: Early language difficulties are associated with poor school readiness and can impact lifelong attainment. The quality of the early home language environment is linked to language outcomes. However, few home-based language interventions have sufficient evidence of effectiveness in improving preschool children's language abilities. This study reports the first stage in the evaluation of a theory-based programme, Talking Together (developed and delivered by BHT Early Education and Training) given over 6 weeks to families in the home setting. We aimed to test the feasibility and acceptability of delivering Talking Together in the Better Start Bradford community prior to a definitive trial, using a two-armed randomised controlled feasibility study. METHODS: Families from a single site within the Better Start Bradford reach area were randomly allocated (1:1) to the Talking Together intervention or a wait list control group. Child language and parent-level outcome measures were administered before randomisation (baseline), pre-intervention (pre-test), 2 months post-intervention start (post-test), and 6 months post-intervention start (follow-up). Routine monitoring data from families and practitioners were also collected for eligibility, consent, protocol adherence, and attrition rates. Descriptive statistics on the feasibility and reliability of potential outcome measures were analysed alongside qualitative feedback on trial design acceptability. Pre-defined progression-to-trial criteria using a traffic light system were assessed using routine monitoring data. RESULTS: Two-hundred and twenty-two families were assessed for eligibility; of these, 164 were eligible. A total of 102 families consented and were randomised (intervention: 52, waitlist control: 50); 68% of families completed outcome measures at 6-month follow-up. Recruitment (eligibility and consent) reached 'green' progression criteria; however, adherence reached 'amber' and attrition reached 'red' criteria. Child- and parent-level data were successfully measured, and the Oxford-CDI was identified as a suitable primary outcome measure for a definitive trial. Qualitative data not only indicated that the procedures were largely acceptable to practitioners and families but also identified areas for improvement in adherence and attrition rates. CONCLUSIONS: Referral rates indicate that Talking Together is a much-needed service and was positively received by the community. A full trial is feasible with adaptations to improve adherence and reduce attrition. TRIAL REGISTRATION: ISRCTN registry ISRCTN13251954. Retrospectively registered 21 February 2019.
RESUMO
BACKGROUND: Problems with oral language skills in childhood have been linked with poor educational, employment, and mental health outcomes. In the UK, there is increasing concern about the oral language skills of children, particularly children from areas of social disadvantage. Research emphasises the importance of the home language environment as a fundamental bedrock for the development of oral language skills. It is vital, therefore, that support is available to help families in need to provide the optimal language environment for their child. Talking Together is a 6-week home visiting programme recently commissioned by Better Start Bradford to develop parents' knowledge of the importance of a good language environment and help to improve parent-child interactions. This study represents the initial steps in developing a definitive trial of the Talking Together programme. METHOD: This study is a two-arm randomised controlled feasibility study in which families referred into the Talking Together programme and consent to participate in the trial will be randomly allocated to either an intervention group or a waiting control group. We will assess the recruitment and retention rates, the representativeness of our sample, the appropriateness of our measures, and the sample size needed for a definitive trial. We will also carry out a qualitative evaluation to explore the acceptability of trial procedures for families and service providers, fidelity of delivery, time and resources for training, and barriers and facilitators to engagement with the programme. Clear progression criteria will be used to assess suitability for a definitive trial. CONCLUSION: This feasibility study will inform the development of a definitive trial of this home-based visiting programme, which will add to the sparse evidence base on which practitioners can draw when supporting families in need. The lessons learnt from this feasibility study will also inform the wider evaluation work of the Better Start Bradford Innovation Hub. TRIAL REGISTRATION: The trial is registered with the ISRCTN registry: study ID ISRCTN13251954. Date of registration: 21 February 2019 (the trial was retrospectively registered).