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Background Young people are vulnerable to the effects of alcohol consumption. Adverse effects from alcohol manifest in a range of short-term and long-term physical and psychosocial factors, including neurological issues, cognitive impairment, and risk-taking behaviours. The aim of the SIPS JR-HIGH, a multicentre randomised controlled trial (RCT), is to assess the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14–15 years in the English high-school setting. Methods Building on a mixed-method cluster-randomised controlled pilot feasibility trial (Current Controlled Trials, ISRCTN07073105), the proposed sample for the definitive trial, to be conducted from September, 2015, to December, 2017, has been calculated to have 90% power and will follow up 257 young people in each arm at 12-month follow-up (ISRCTN45691494). 20 schools will be recruited (in September, 2015), five of which will be from North East England, North West England, London, and Kent. The RCT will incorporate a control arm of usual school-based practice on alcohol issues and an intervention arm that combines usual care with a 30 min brief intervention delivered by school learning mentors. Individual pupils will be randomised to one of the two arms. The primary outcome will be total alcohol consumed in the past 28 days judged by the 28 day Time Line Follow Back method. Descriptive statistical analysis will be used to report the pupil-level baseline data, with multiple linear regressions being used to compare the primary outcomes between the two arms at 12 months. Findings The pilot trial guided the development of the manualised intervention, which includes process information and a 30 min personalised interactive worksheet-based session delivered by learning mentors. The pilot suggested that this intervention was acceptable, but an intervention with parental involvement was not found to be feasible, with parents not engaging with the research. Interpretation Little evidence exists in a UK context to explore screening and brief intervention to reduce risky drinking in young adolescents. The pilot trial has informed the design of the upcoming definitive trial which, if the intervention is effective, will facilitate the development of manualised screening and brief intervention to be adopted in routine school practice in high schools in England. Funding This project is funded by the National Institute for Health Research (NIHR) Public Health Research (PHR) programme (project number 13/117/02).

Background Early and heavy drinking by young adolescents is linked to intellectual impairment, increased risk of injury, mental health issues, unprotected or regretted sexual experience, violence, and sometimes accidental death. Our aim was to assess the feasibility of delivering brief alcohol intervention in a school setting with adolescents aged 14–15 years; and to examine the acceptability of study measures to staff, young people, and parents, including take-up and follow-up rates. Methods Seven schools across one geographical area in northeast England were recruited to this feasibility pilot trial. All schools within the study catchment area were judged eligible and approached to take part. Randomisation was done at the school level to reduce the chance of contamination. Allocation of schools to intervention was done by the study statistician, taking school size and socio-economic factors (proportion of free school meals) into account. Each school was randomly allocated to one of three groups: provision of an advice leaflet (control condition, two schools); a 30-min personalised session of structured advice delivered by the school learning mentor (level 1 condition, two schools); and a 60-min session with family members (level 2 condition, three schools). Trial participants were year 10 school pupils (aged 14–15 years) who screened positively for alcohol misuse with an alcohol screening questionnaire and who had consented to take part in the trial (n=181). Recruitment began on Jan 24, 2012, and finished on July 31, 2012. Statistical analyses were mainly descriptive, providing an estimate of eligibility, recruitment, intervention delivery, and retention rates in the study population. These key feasibility pilot trial parameters will inform the power calculation for a future definitive trial and confirm other aspects of trial design (particularly the acceptability of study processes and outcome measures to young people, their parents, teachers, and learning mentors). Findings This presentation focuses on the development of two manual-guided interventions for use with adolescents and parents, both of which encompass motivational interviewing principles and elements of the FRAMES approach to elicit behaviour change, which consists of the following elements: feedback, responsibility, advice, menu, empathy, and self-efficacy. Interventions were developed and piloted with young people and parents; training for learning mentors was divided into two half-day sessions. Each intervention used an A3-sized interactive document designed to promote a conversation about alcohol. The level 1 intervention was structured around a six-step method consisting of personalised feedback about drinking behaviour and advice about the health and social consequences of continued hazardous alcohol consumption. The level 2 intervention was structured around a four-step method designed to explore the young person's motivation to change their drinking behaviour and the family's motivation to facilitate and support change (appendix). Interpretation Although the use of brief interventions for adults is established in a health setting and there is evidence of their effectiveness in college and university students, very little work has been done in the UK to explore the early identification (screening) and brief intervention to reduce risky drinking in younger adolescents (aged 11–15 years), making a feasibility pilot study a necessary and important step of a definitive assessment. Results from this feasibility pilot trial will inform the development of a definitive randomised controlled trial to assess the effectiveness and cost-effectiveness of screening and brief alcohol intervention to reduce hazardous drinking in adolescents in a school setting. Funding This project is funded by the National Institute for Health Research Public Health Research (NIHR PHR) programme (project number 10/3002/07).

Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742) attending their booking appointment with a community midwife (n = 31) in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C). Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120). Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control) or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention). As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention delivery, and retention in the study population, to inform power calculations for a definitive trial. The health-economics component will establish how cost-effectiveness will be assessed, and examine which data on health service resource use should be collected in a main trial. Participants’ views on instruments and procedures will be sought to confirm their acceptability. Discussion The study will produce a full trial protocol with robust sample-size calculations to extend evidence on effectiveness of screening and brief intervention. Trial Registration Current Controlled Trials ISRCTN43218782