A brief alcohol intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting
| ISRCTN | ISRCTN07073105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07073105 |
| Secondary identifying numbers | 01 |
- Submission date
- 11/08/2011
- Registration date
- 26/09/2011
- Last edited
- 21/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Early and heavy drinking by younger adolescents is a significant public health problem which is linked to intellectual impairment, increased risk of accidents, injuries, self harm, unprotected sex, violence and sometimes accidental death. To date, there has been very little work in the UK on early identification (screening) and brief intervention to reduce risky drinking in this age group. This research aims to test if it is possible to conduct a research project with younger adolescents attending high school, and their parents, which tries to reduce risky youth drinking.
Who can participate?
All year 10 students (aged 14-15) will be invited to take part in the study in seven high schools in the North East of England (North Tyneside, Tyne and Wear).
What does the study involve?
Students will be randomly allocated to one of three groups:
Control group: Standard alcohol advice as delivered as part of the school curriculum in Personal, Social and Health Education (PSHE).
Level One Intervention group: In addition to PSHE the young people who screen positively for alcohol misuse using the alcohol screening questionnaire will take part in a 30 minute personalised session delivered by the Learning Mentor (LM) (at school) of structured feedback about their drinking behaviour and advice about the health and social consequences of continued hazardous alcohol consumption. The young people will also receive a healthy living booklet and information on local sources of help for drinking problems. The intervention encompasses the elements of the FRAMES approach for eliciting behaviour change (Feedback, Responsibility, Advice, Menu, Empathy and Self-efficacy).
Level Two Intervention group: In addition to PSHE and the level one intervention, the young people will be invited to attend a subsequent one hour session of behaviour change counselling delivered by the Learning Mentor which will occur after school hours and will have parental involvement. This session will only take place if both the parent and the young person consent. This intervention utilises the technique of motivational interviewing and aims to address the individual's motivation to change their drinking behaviour. The counselling is manual guided. Level Two Interventions will take place at the young person and parents convenience in a community centre either within the school or nearby.
What are the possible benefits and risks of participating?
What participants will gain from enrolling is a leaflet on healthy lifestyles/alcohol use. There are no known risks to participating in the study.
Where is the study run from?
The study is run from the Institute of Health and Society, Newcastle University.
When is the study starting and how long is it expected to run for?
The study start date is 1st October 2011 for 22 months. The trial will be recruiting participants between December 2011 and May 2012 and then carrying out follow ups 6 and 12 months after.
Who is funding the study?
The National Institute for Health Research, Public Health Research Programme (NIHR PHRP).
Who is the main contact?
Dr Dorothy Newbury-Birch
dorothy.newbury-birch@ncl.ac.uk
Contact information
Scientific
Institute of Health and Society
Newcastle University
Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom
Study information
| Study design | Cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | School |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A feasibility trial of screening and brief alcohol intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting |
| Study objectives | Alcohol screening and brief interventions carried out in the school setting can prevent hazardous drinking in young people |
| Ethics approval(s) | Newcastle University Ethics Comittee, August 2011 |
| Health condition(s) or problem(s) studied | Alcohol use disorders |
| Intervention | Level One Intervention: In addition to Personal Social and Health Education (PSHE) the young people in year 10 (aged 14 to 15) who screen positively for alcohol misuse using the alcohol screening questionnaire and consent to take part in the study will take part in a 30 minute personalised session delivered by the Learning Mentor (LM) (at school) of structured feedback about their drinking behaviour and advice about the health and social consequences of continued hazardous alcohol consumption. The young person (YP) will also receive a healthy living booklet and information on local sources of help for drinking problems. The intervention encompasses the elements of the FRAMES approach for eliciting behaviour change (Feedback, Responsibility, Advice, Menu, Empathy and Self-efficacy) (Miller and Sanchez 1993). Level Two Intervention: In addition to PSHE and the level one intervention, the YP will be invited to attend a subsequent one hour session of behaviour change counselling delivered by the LM which will occur after school hours and will have parental involvement. This session will only take place if both the parent and the young person agrees. This intervention utilises the technique of motivational interviewing (Rollnick, Mason et al. 1999) and aims to address the individual's motivation to change their drinking behaviour. The counselling is manual guided. Level Two Interventions will take place after school hours in a community centre either within the school or nearby. Adolescents in the control and intervention will all receive Personal Social Health and Economic education (PSHE) as usually delivered in the high school setting. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. To assess the acceptability of the proposed methods used in this study to be used in a definitive trial to assess total alcohol consumed in a 28 day period of the study population. This is ascertained using the 28 day timeline follow back questionnaire. Three other variables can be derived from the data: 1.1. Percent days abstinent 1.2. Drinks per drinking day 1.3. Total alcohol consumed The time line follow back interview will be conducted by a trained individual and takes approximates 20 minutes to complete. The primary outcome will only be measured at 12 months post intervention so as not to bias the control group's responses. |
| Secondary outcome measures | 1. Alcohol use frequency, quantity (on a typical occasion) and binge drinking will be assessed using the Alcohol Use Disorders Identification Test (AUDIT). Each item scores between zero and four and the maximum score is forty. A score of 2+ will be used to categorise someone as hazardous / harmful drinking (2+) and 3+ for possible dependence (3+) 2. Alcohol related problems will be assessed using the validated Rutgers Alcohol Problems Inventory (RAPI) which includes measures on aggression 3. The 12 item General Health Questionnaire (GHQ) will be used to assess general psychological health 4. Cost data will be collected using the client receipt approach 5. The EQ-5D-Y which is a recently developed child-friendly version of the EQ-5D will be used to investigate if this instrument achieves acceptable completion rates and to see if it detects any differences in health utility scores between the intervention groups and the control group Measured at baseline, 6 months post intervention and 12 months post intervention |
| Overall study start date | 01/10/2011 |
| Completion date | 31/07/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 14 Years |
| Upper age limit | 15 Years |
| Sex | Both |
| Target number of participants | 232 recruited to study; 169 followed up at 6 months and 110 followed up at 12 months |
| Key inclusion criteria | 1. Pupils aged 14-15 years inclusive, scoring positive on the Single Alcohol Questionnaire (SAQ) 2. Willing and able to provide informed consent for intervention and follow up |
| Key exclusion criteria | 1. Parental refusal 2. Those already seeking help for an alcohol use disorder (AUD) |
| Date of first enrolment | 01/12/2011 |
| Date of final enrolment | 01/05/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NE2 4AX
United Kingdom
Sponsor information
University/education
c/o Ms Amanda Tortice
Level 6, Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.ncl.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/01kj2bm70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/09/2012 | Yes | No | |
| Results article | results | 01/11/2014 | Yes | No |
