Screening and brief alcohol intervention to prevent risky drinking in young people aged 14-15 in a high school setting
| ISRCTN | ISRCTN45691494 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45691494 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 002 |
| Sponsor | Newcastle University |
| Funder | National Institute for Health Research |
- Submission date
- 21/08/2015
- Registration date
- 15/09/2015
- Last edited
- 10/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
1.21 Constantine Building
Teesside University
Middlesbrough
TS1 3BA
United Kingdom
| 0000-0002-2166-3300 |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre two-arm randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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) |
| Study acronym | SIPS JR-HIGH |
| Study objectives | 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(s) | Teesside University Ethics Committee, 03/09/2015, ref: 164/15 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Total alcohol consumed in the last 28 days, using the 28 day Alcohol Timeline Followback (TFLB) questionnaire at 12-month follow-up. |
| Key secondary outcome measure(s) |
1. Percentage days abstinence over last 28 days, drinks per drinking day and days >2 units from TLFB |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Learner/student |
|---|---|
| Age group | Child |
| Lower age limit | 14 Years |
| Upper age limit | 15 Years |
| Sex | All |
| Target sample size at registration | 257 |
| Total final enrolment | 443 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 31/03/2016 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Ferryhill
County Durham
DL17 8RW
United Kingdom
Newtom Aycliffe
County Durham
DL5 7LF
United Kingdom
Newton Aycliffe
County Durham
WC2R 2LS
United Kingdom
Durham
County Durham
DH1 4SU
United Kingdom
Consett
County Durham
DH8 8EG
United Kingdom
Chester le Street
County Durham
DH3 3QA
United Kingdom
Barnard Castle
County Durham
DL12 8HH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2019 | 10/12/2020 | Yes | No |
| Results article | 12/03/2022 | 10/10/2023 | Yes | No | |
| Protocol article | protocol | 23/12/2016 | 10/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/10/2023: Publication reference added.
10/12/2020: The following changes were made to the trial record:
1. Publication references added.
2. The total final enrolment was added.