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Additional file 3: Supplementary file 3: Completion rates. Table 1: Data completeness of outcome measures collected at baseline. Table 2: Summary of data completeness for measures included in the T1 assessment for those who have completed a T1 questionnaire.Table 3: Summary of data completeness for measures included in the T2 assessment for those who have completed a T2 questionnaire.Table 4: Summary of data completeness for measures included in the T3 assessment for those who have completed a T3 questionnaire.

Additional file 2: Supplementary file 2: Summary of ward level baseline data over the previous 12 month period

Additional file 1: Supplementary file 1. CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial.

Background: Alcohol interventions are important to the developing public health role of community pharmacies.\ud The Medicines and Alcohol Consultation (MAC) is a new intervention, co-produced with community pharmacists\ud (CPs) and patients, which involves a CP practice development programme designed to integrate discussion of\ud alcohol within existing NHS medicine review services. We conducted a pilot trial of the MAC and its delivery to\ud investigate all study procedures to inform progression to a definitive trial.\ud Methods: This cluster pilot RCT was conducted in 10 community pharmacies in Yorkshire, UK, with a CP from each\ud who regularly conducted Medicine Use Review (MUR) and New Medicine Service (NMS) consultations. Randomisation\ud was conducted using a secure remote randomisation service. Intervention CPs (n = 5) were trained to deliver the MAC in\ud MUR/NMS consultations. Control CPs (n = 5) provided these services as usual. Consecutive MUR/NMS patients were asked\ud by CPs to participate, screened for eligibility (consumption of alcohol at least twice per week), and baseline data collected\ud for those eligible. A two-month follow-up telephone interview was conducted. Blinding of CPs was not possible, but\ud patients were blinded to the alcohol focus of the trial. Primary outcomes were total weekly UK units (8 g of ethanol per\ud unit) of alcohol consumption in the week prior to follow-up, and confidence in medications management.\ud Trial procedures were assessed by recruitment, attrition, and follow-up rates.\ud \ud Results: 260 patients were approached by CPs to take part in the trial, 68% (n = 178) were assessed for\ud eligibility and 30% (n = 54) of these patients were eligible. Almost all eligible patients (n = 51; 94%) consented\ud to participate, of whom 92% (n = 47) were followed-up at 2 months; alcohol consumption was lower in the\ud intervention arm and confidence in medication management reduced slightly for both groups. Exploration of\ud recall issues at follow-up showed a high level of agreement between a two-item quantity/frequency measure\ud and 7-day guided recall of alcohol consumption.\ud Conclusions: The pilot trial demonstrates the feasibility of implementing the MAC in community pharmacy\ud and trial recruitment and data collection procedures. However, decommissioning of MURs means that it is not\ud possible to conduct a definitive trial of the intervention in this service.\ud Trial registration: ISRCTN57447996\ud Keywords: Alcohol, Community pharmacy, Medicine reviews, Pilot trial, Feasibility

Statistical methods, outcomes and estimation. (DOCX 272 kb)

Release notes for 59 software development cycles between June 2015 and June 2017. (DOCX 17 kb)

Changes to intervention and trial procedures. (DOCX 22 kb)

Study protocol and interview guides. (PDF 2311 kb)

CONSORT checklist. (DOC 226 kb)

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.

Example Stata code used to run the simulations described in the manuscript text. (DOCX 16 kb)

Additional details including: model fitting code for Stata, R, and SAS for the homoscedastic and heteroscedastic partially nested models; performance measures; and results tables. (DOCX 189 kb)

Generic code. R and Stata code for models and ICC calculations. This file contains the R and Stata code required to implement the models used throughout this article. (DOCX 22 kb)