Condition category
Mental and Behavioural Disorders
Date applied
21/08/2015
Date assigned
15/09/2015
Last edited
14/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In England between 2007 and 2013, alcohol consumption in 11-15 year olds decreased from 54% to 39%. Although this reduction in underage drinking is encouraging, teenagers in the UK are still amongst the heaviest drinkers in Europe. There is a great deal of evidence to show that underage drinking can lead to health and social problems in later life. It can also lead to risky behaviour in teenagers, such as smoking and promiscuity (sleeping around). “Alcohol screening and brief intervention” is a preventive strategy targeting people whose drinking habits are likely to be harmful to their health or well-being. The scheme works by identifying young people engaging in risky drinking behaviour, and then providing structured advice or counselling to help them drink less and more responsibly. A key feature of this programme is that it is designed by GP’s rather than addiction specialists, as the participants themselves may not be aware that they have a problem with alcohol. The aim of this study is to find out whether an alcohol screening and brief intervention programme in schools is a successful and cost-effective way of reducing drinking in young people.

Who can participate?
Healthy adolescents between 14 and 15 years old who have a risky level of alcohol consumption.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in the first group (control) continue their usual school lessons to help them understand alcohol issues. They are also given minimal feedback from their alcohol consumption screening, as well as an alcohol information leaflet which includes information about how to get help with alcohol-related issues. Those in the second group (intervention) receive the same leaflet and normal school lessons as the control group, however they also take part in a 30 minute personalized, interactive worksheet-based session designed to explore the young persons’ drinking habits and their motivation for change. These participants also receive structured feedback from the alcohol use screening, as well as advice about the long-term problems linked with drinking too much alcohol.

What are the possible benefits and risks of participating?
There are no direct benefits of participating, although information gained from the study will be used for an intervention manual to be used in schools in the future. All young people involved will be given an information leaflet with information about alcohol and contact details of local help services however. There are no specific risks involved.

Where is the study run from?
Seven schools in the County Durham area.

When is the study starting and how long is it expected to run for?
September 2015 to December 2017

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Emma Giles

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Giles

ORCID ID

http://orcid.org/0000-0002-2166-3300

Contact details

1.21 Constantine Building
Teesside University
Middlesbrough
TS1 3BA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

002

Study information

Scientific title

A multi-centre randomised controlled trial of screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH)

Acronym

SIPS JR-HIGH

Study hypothesis

The aim of the study is to evaluate the effectiveness and cost-effectiveness of alcohol screening and brief intervention to reduce risky drinking in young people aged 14-15 in the English high school setting.

Ethics approval

Teesside University Ethics Committee, 03/09/2015, ref: 164/15

Study design

Multi-centre two-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet

Condition

Risky alcohol consumption

Intervention

Participants are randomised in a 1:1 ratio into the intervention and control arms, with individual randomisation stratified by school.

Control arm: Involves usual practice on alcohol issues as delivered normally to all students in personal, social and health education (PSHE) lessons and curriculum delivered by class teachers as well as minimal feedback on their alcohol screen and an alcohol information leaflet with information on local sources of help for problems relating to alcohol, given by the learning mentor to those that consent to the trial.

Intervention arm: In addition to input equivalent to the control arm; the young people who are eligible and consent to participate in a 30-minute personalised interactive worksheet-based session. This will be delivered by the learning mentor (at school) and will contain structured feedback about the individual student’s drinking behaviour and advice about the health and social consequences of continued risky alcohol consumption. The intervention encompasses the elements of the FRAMES approach for eliciting behaviour change.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Total alcohol consumed in the last 28 days, using the 28 day Alcohol Timeline Followback (TFLB) questionnaire at 12-month follow-up.

Secondary outcome measures

1. Percentage days abstinence over last 28 days, drinks per drinking day and days >2 units from TLFB
2. Risky drinking using the A-SAQ (last 6 months), AUDIT (last 6 months) and TFLB (last 28 days)
3. Smoking behavior (age of first use and amount used in last 30 days)
4. Alcohol related problems using the RAPI (last 6 months)
5. Drunkenness during the last 30 days, both dichotomised as ‘never’ and ‘1-2 times or more'
6. Emotional wellbeing using the WEMWBS in the last two weeks
7. Drinking motives using the DMQ (last 6 months)
8. Energy drink consumption (last week)
9. Use of NHS, educational, social, and criminal services data (S-SUQ) (last 6 months)
10. Quality of life and health utility measured using EQ-5D 5L (today)
11. Sexual risk taking: "After drinking alcohol, have you engaged in sexual intercourse that you regretted the next day?” and “After drinking alcohol, have you ever engaged in sexual intercourse without a condom?” (ever)

Overall trial start date

01/09/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 14-15 years inclusive whose parents do not opt them out of the study
2. Scoring positively for risky alcohol consumption on the Self-Assessment Questionnaire A (A-SAQ)

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

The proposed sample has been calculated to have a 90% power and will follow-up 257 young people in each arm at 12-month follow up.

Participant exclusion criteria

1. Those already seeking or receiving help for an alcohol use disorder
2. Those with a recognised mental health or challenging behaviour issue

Recruitment start date

01/01/2016

Recruitment end date

31/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ferryhill Business & Enterprise College
Merrington Road Ferryhill
County Durham
DL17 8RW
United Kingdom

Trial participating centre

Greenfield Community College - A Specialist Arts & Science School
Greenfield Way Newtom Aycliffe
County Durham
DL5 7LF
United Kingdom

Trial participating centre

Woodham Academy
Washington Crescent Newton Aycliffe
County Durham
WC2R 2LS
United Kingdom

Trial participating centre

Durham Johnston School
Crossgate Moor Durham
County Durham
DH1 4SU
United Kingdom

Trial participating centre

Consett Academy
Dunelm Rd Consett
County Durham
DH8 8EG
United Kingdom

Trial participating centre

Park View Community School
Church Chare Chester le Street
County Durham
DH3 3QA
United Kingdom

Trial participating centre

Teesdale School
Prospect Pl Barnard Castle
County Durham
DL12 8HH
United Kingdom

Sponsor information

Organisation

Newcastle University

Sponsor details

Faculty of Medical Sciences
Newcastle University
Framlington Place
Newcastle upon Tyne
NE2 4HH
United Kingdom

Sponsor type

University/education

Website

www.ncl.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We will publish a full account of our research in the journal NIHR Public Health Research. In addition, we anticipate that this research will result in three open access peer-reviewed journal articles. Target journals include BMC Trials for the protocol and Addiction for the main results of the trial. We anticipate that a paper reporting further results will also be published in a specialist journal.
Furthermore we will ensure that our outputs are placed on Researchfish. We will also present our research at meetings of appropriate learned societies. Findings will also be disseminated with local and national education departments. We will work with press officers at Newcastle University to publicise the results of our work to local and national news media.
The Chief Investigator (Newbury-Birch) and other co-applicants are associate members of FUSE – The Centre for Translational Research in Public Health (www.fuse.ac.uk). FUSE is a UKCRC funded Centre of Public Health Research Excellence which includes members and partners from across public health research, policy and practice communities in the North East of England. We will use established Fuse initiatives including the Quarterly Research Meetings (with around 100 participants) to disseminate our findings to the wider public health community. A summary of these meeting, and podcasts of presentations, will be posted on the FUSE website.
Key to the study is the role played by school staff and young people. We will consult with them at the start of the study, informing them about study activities and inviting them to comment on how the project can be improved. In so doing we will be encouraging those involved to engage with the project so that they will more readily contribute to meetings in the latter stages of the project where we will be asking for their input to help the research team generate ideas for dissemination. Finally, we have allocated funds for a member of the research team to attend one international and one national conference to disseminate findings to a wider practitioner/research community. We anticipate that the former will be to the Royal Society on Alcoholism and the latter will be the Alcohol Concern Conference.

Intention to publish date

30/06/2018

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes