Condition category
Mental and Behavioural Disorders
Date applied
11/08/2011
Date assigned
26/09/2011
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dorothy Newbury-Birch

ORCID ID

Contact details

Institute of Health and Society
Newcastle University
Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01

Study information

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

Acronym

Study hypothesis

Alcohol screening and brief interventions carried out in the school setting can prevent hazardous drinking in young people

Ethics approval

Newcastle University Ethics Comittee, August 2011

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/10/2011

Overall trial end date

31/07/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

232 recruited to study; 169 followed up at 6 months and 110 followed up at 12 months

Participant exclusion criteria

1. Parental refusal
2. Those already seeking help for an alcohol use disorder (AUD)

Recruitment start date

01/12/2011

Recruitment end date

01/05/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Newcastle University
Newcastle upon Tyne
NE2 4AX
United Kingdom

Sponsor information

Organisation

Newcastle University (UK)

Sponsor details

c/o Ms Amanda Tortice
Level 6
Leazes Wing
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

University/education

Website

http://www.ncl.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Public Health Research Programme ref: 10/3002/07

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22974108
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25642576

Publication citations

  1. Protocol

    O'Neil S, Coulton S, Deluca P, Deverill M, Drummond C, Gilvarry E, Graybill E, Harle C, Howel D, Kaner E, McArdle P, McColl E, McGovern R, Speed C, Stamp E, Tate L, Newbury-Birch D, Brief intervention to prevent hazardous drinking in young people aged 14-15 in a high school setting (SIPS JR-HIGH): study protocol for a randomized controlled trial., Trials, 2012, 13, 166, doi: 10.1186/1745-6215-13-166.

  2. Results

    Newbury-Birch D, Scott S, O’Donnell A, Coulton S, Howel D, McColl E, Stamp E, Graybill E, Gilvarry E, Laing K, McGovern R, Deluca P, Drummond C, Harle C, McArdle P, Tate L, Kaner E, A pilot feasibility cluster randomised controlled trial of screening and brief alcohol intervention to prevent hazardous drinking in young people aged 14–15 years in a high school setting (SIPS JR-HIGH).

Additional files

Editorial Notes