A randomised controlled feasibility trial of an early years language development intervention: results of the 'outcomes of Talking Together evaluation and results' (oTTer) project.

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.

Cancer Prehabilitation in Practice: the Current Evidence.

PURPOSE OF REVIEW: This article serves to describe recent controversies in cancer prehabilitation including efficacy, dose, cost effectiveness, stakeholder input, and international implementation. RECENT FINDINGS: Appropriate frequency, type, and timing have yet to be determined, but high intensity exercise is recommended. Costs are favorable when modeled and information on costs of real-world application are forthcoming. Patients are interested in and willing to attend cancer prehabilitation. Cancer prehabilitation research is spreading throughout the world. Cancer prehabilitation includes assessment of a newly diagnosed cancer patient's baseline fitness and targeted interventions to improve their health before surgery, chemotherapy, or radiation. Cancer prehabilitation improves fitness as measured preoperatively and improves outcomes postoperatively.

Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE): a study protocol of a community-based randomised controlled trial with process and economic evaluations of the incredible years infant and toddler parenting programmes, delivered in a proportionate universal model.

INTRODUCTION: Behavioural and mental disorders have become a public health crisis and by 2020 may surpass physical illness as a major cause of disability. Early prevention is key. Two Incredible Years (IY) parent programmes that aim to enhance child well-being and development, IY Infant and IY Toddler, will be delivered and evaluated in a proportionate universal intervention model called Enhancing Social-Emotional Health and Wellbeing in the Early Years (E-SEE) Steps. The main research question is: Does E-SEE Steps enhance child social emotional well-being at 20 months when compared with services as usual? METHODS AND ANALYSIS: E-SEE Steps will be delivered in community settings by Early Years Children's Services and/or Public Health staff across local authorities. Parents of children aged 8 weeks or less, identified by health visitors, children's centre staff or self-referral, are eligible for participation in the trial. The randomisation allocation ratio is 5:1 (intervention to control). All intervention parents will receive an Incredible Years Infant book (universal level), and may be offered the Infant and/or Toddler group-based programme/s-based on parent depression scores on the Patient Health Questionnaire or child social emotional well-being scores on the Ages and Stages Questionnaire: Social Emotional, Second Edition (ASQ:SE-2). Control group parents will receive services as usual. A process and economic evaluation are included. The primary outcome for the study is social emotional well-being, assessed at 20 months, using the ASQ:SE-2. Intention-to-treat and per protocol analyses will be conducted. Clustering and hierarchical effects will be accounted for using linear mixed models. ETHICS AND DISSEMINATION: Ethical approvals have been obtained from the University of York Education Ethics Committee (ref: FC15/03, 10 August 2015) and UK NHS REC 5 (ref: 15/WA/0178, 22 May 2015. The current protocol is Version 9, 26 February 2018. The sponsor of the trial is the University of York. Dissemination of findings will be via peer-reviewed journals, conference presentations and public events. TRIAL REGISTRATION NUMBER: ISRCTN11079129; Pre-results.