Plain English Summary
Background and study aims
Adolescence is a period when young people increasingly begin to experiment with alcohol, and as they get older they increase their consumption both in terms of the amount and frequency of use. Alcohol misuse among adolescents occurs in most countries worldwide, although the UK reports some of the highest levels in the EU. Consequences of heavy alcohol use in young people are extensive and adversely impact upon health, educational achievement, societal cohesion, criminality, welfare and well-being. There are clear geographic differences in the burden alcohol places on the population, and these are closely associated with other major indicators of ill health and health inequalities. Indeed, differences in alcohol use are thought to be one of the major determinants of health and social inequalities. Given the prevalence of underage drinking in the UK, the reported problems, costs and harms associated with this behaviour, and the lack of a robust UK evidence base for alcohol prevention we wish to investigate how well a school based alcohol education curriculum with parental training components will work in reducing hazardous levels of drinking and alcohol related harms in school children in Northern Ireland and Glasgow/Inverclyde Local Authorities.
Who can participate?
Participants are male and female children aged 13 and 14 attending post-primary schools in Northern Ireland and Glasgow/Inverclyde Local Authorities. Children with special educational needs will participate at the discretion of their teachers as the intervention materials have not been adapted for this group of children.
What does the study involve?
The treatment to be tested is an adapted version of the School Health and Alcohol Harm Reduction Project (SHAHRP), which was developed in Australia, with the addition of a parental component designed to help parents set rules around alcohol in the family home. The combined treatment is called STAMPP - Steps Towards Alcohol Misuse Prevention Programme (STAMPP). One set of schools will receive STAMPP, the other will receive their usual school alcohol education. Parents of children who receive alcohol education as normal will not be invited to receive any type of intervention.
Phase 1 of STAMPP is delivered when pupils are in the second year of post-primary education (aged at least 13 on 01/09/2012), coinciding with the onset of alcohol use for many children, and phase 2 a year later, when alcohol use becomes more established. Phase 1 consists of six sessions (with 16 activities) and phase 2 consists of four sessions (with 10 activities). Each lesson uses skills-based activities and individual and small group discussions to emphasise the identification of alcohol-related harm and the development of harm reduction strategies. Interactive involvement is a key feature of the sessions. Based on previous work it is likely that changes in alcohol use associated with the classroom curriculum are influenced by changes in self efficacy, self regulation, and time perspective and orientation, whereby the skills developed in the sessions enable children to make more accurate decisions on the likely immediate short and long term consequences of different types of alcohol use, and to develop (and adhere to) personal and group strategies to reduce harm experienced by the recipients' own and others' alcohol use. These changes will be reinforced and supported by changes in family based skills.
Parents receive an intervention comprising a short standardised presentation delivered by a trained facilitator at school parent evenings. The presentation includes information on alcohol prevalence in young people, corrects parents' (under)estimates of youth drinking, and highlights the importance of setting strict family rules around alcohol. The presentation is followed by a brief discussion on family rules, and followed up by a leaflet providing a summary of the key information from the evening.
The classroom intervention is delivered by specially trained teachers. Teacher training will be conducted in the school setting and include an introduction to the concepts involved in harm reduction, rehearsal of delivery of each of the sessions in that intervention phase, and awareness of raising of potentially difficult issues/areas around alcohol. Additionally, teachers will be provided with a support pack which includes detailed lesson plans, and alcohol information sheets. The parental component is delivered by trained prevention practitioners and takes place in the school or community setting.
What are the possible benefits and risks of participating?
Previous research has shown that the classroom component of STAMPP was associated with a reduction in children's drinking and a reduction in the harms they experienced as a result of their own (e.g. risky behaviour) or others' (e.g. fights) drinking. As with all substance use education interventions there is a small risk that some children's interest in alcohol will be piqued by participation in the trial and will initiate use at an earlier age. However, young people are subject to many other social, cultural, and family influences in their day to day life which are likely to have a greater effect on drinking initiation than participation in this research.
Where is the study run from?
105 schools will take part in the research. The principal investigator is based in Liverpool, UK, although university researchers in Oxford and Belfast are also collaborating.
When is the study starting and how long is it expected to run for?
The study will start in 2011 and last for 51 months. School recruitment is expected to have finished by May 2012. The intervention will begin in Autumn 2012 and takes place across two annually delivered blocks of lessons.
Who is funding the study?
National Institute for Health Research - Public Health Research Programme (UK)
Who is the main contact?
Prof. Harry Sumnall
h.sumnall@ljmu.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Harry Sumnall
ORCID ID
Contact details
Centre for Public Health
Liverpool John Moores University
Henry Cotton Building
Webster Street
Liverpool
L3 2ET
United Kingdom
-
h.sumnall@ljmu.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
10/3002/09
Study information
Scientific title
The effectiveness of a classroom psychoeducational intervention with parental components in reducing hazardous drinking and the harms associated with alcohol use in school pupils compared with education as usual (EAU)
Acronym
STAMPP
Study hypothesis
Current hypothesis as of 17/02/2015:
Is a classroom psychoeducational intervention with parental components (STAMPP) [cost] effective in reducing hazardous drinking and the harms associated with alcohol use in young people compared with education as usual (EAU)?
This will be assessed by determining changes in several indicators of alcohol consumption, alcohol cognitions, and other alcohol-related behaviour.
The primary research objectives of STAMPP are:
1. To ascertain the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (defined as self-reported consumption of ≥6 units in a single episode in the previous 30 days for males and ≥4.5 units for females) in school pupils (school year 9/S2 in the academic year 2012/2013) at + 33 months (T3) from baseline. This will be dichotomised at never/one or more occasions.
2. To ascertain the effectiveness of STAMPP in reducing alcohol-related harms as measured by the number of self-reported harms (harms caused by own drinking) in school pupils (school year 9/S2 in the academic year 2012/2013) at +33 months (T3) from baseline
The secondary research objectives of STAMPP are:
1. To ascertain the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (defined as self-reported consumption of ≥6 units in a single episode in the previous 30 days for males and ≥4.5 units for females) in school pupils (school year 9/S2 in the academic year 2012/2013) at + 24 months (T2) from baseline. This will be dichotomised at never/one or more occasions.
2. To ascertain the effectiveness of STAMPP in reducing alcohol consumption (self-reported alcohol use in lifetime, last year and previous month; number of drinks in ‘typical’ and last use episodes; age of alcohol initiation, unsupervised drinking) in school pupils (school year 9/S2 in the academic year 2012/2013), at +24 (T2) months and + 33 (T3) months.
3. To ascertain the effectiveness of STAMPP in reducing alcohol-related harms as measured by self-reported harms caused by own drinking at +24 months (T2), and self-reported harms caused by the drinking of others at +24 (T2) months and + 33 (T3) months, in school pupils (school year 9/S2 in the academic year 2012/2013).
Previous hypothesis from 25/11/2013 to 17/02/2015:
Is a classroom psychoeducational intervention with parental components (STAMPP) [cost] effective in reducing hazardous drinking and the harms associated with alcohol use in young people compared with education as usual (EAU)?
This will be assessed by determining changes in several indicators of alcohol consumption, alcohol cognitions, and other alcohol related behaviour.
The primary research objective of STAMPP is:
1. To determine the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (frequency of consuming >5 drinks in a single episode in the previous 30 days) in second form pupils (aged at least 13 on the 01/09/2012) at + 18 months after intervention.
The secondary research objectives of STAMPP are:
1. To ascertain the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (frequency of consuming >5 drinks in a single episode in the previous 30 days) in second form pupils (aged at least 13 on 01/09/2012) at + 6 months after intervention.
2. To ascertain the effectiveness of STAMPP in reducing alcohol consumption (self-reported alcohol use in lifetime, last year and previous month; number of drinks in typical and last use episodes; age of alcohol initiation, unsupervised drinking) in second form pupils (aged at least 13 on 01/09/2012) at + 6 months and + 18 months after intervention.
3. To ascertain the effectiveness of STAMPP in reducing alcohol-related harms as measured by health service utilisation and self-reported harms (harms caused by own drinking and that of others) in second form pupils (aged at least 13 on 01/09/012) at + 6 months and + 18 months after intervention.
Original hypothesis:
Is a classroom psychoeducational intervention with parental components (STAMPP) [cost] effective in reducing hazardous drinking and the harms associated with alcohol use in young people compared with education as usual (EAU)?
This will be assessed by determining changes in several indicators of alcohol consumption, alcohol cognitions, and other alcohol related behaviour.
The main objectives of the research are to determine the following in year 10 pupils immediately post intervention, + 6 months and + 18 months after intervention:
1. The (cost) effectiveness of STAMPP in reducing alcohol consumption:
1.1. Self reported alcohol use in lifetime
1.2. Last year and previous month
1.3. Number of drinks in 'typical' and last use episodes
1.4. Frequency of consuming >5 drinks in a single episode in the previous 30 days
1.5. Age of alcohol initiation
2. The effectiveness of STAMPP in reducing alcohol related harms as measured by health service utilisation and self reported harms (harms caused by own drinking and that of others)
3. Which components of STAMPP make it effective in reducing alcohol related harm
4. What are the behavioural and cognitive mediators of change (individual and family factors) that lead to the effectiveness of STAMPP
Ethics approval
Liverpool John Moores University Ethics Board, November 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 to request a patient information sheet
Condition
Alcohol drinking and experiences of harms associated with own and others' use of alcohol
Intervention
Current interventions as of 25/11/2013:
STAMPP is a UK adaptation of the Australian developed Schools Alcohol Harm Reduction Programme (SHAHRP) with the inclusion of a parental component that is delivered (staggered introduction) in Phase 2 of the classroom intervention.
Phase 1 is delivered when pupils are in the second year of post primary schooling, coinciding with the onset of alcohol use for many children, and phase 2 one year later, when alcohol use becomes more established.
Phase 1 consists of six sessions (with 16 activities) and phase 2 consists of four sessions (with 10 activities). Each lesson uses skills-based activities and individual and small group discussions to emphasise the identification of alcohol-related harm and the development of harm reduction strategies. Interactive involvement is a key feature of the sessions.
Based on previous work it is hypothesised that changes in alcohol outcomes associated with the classroom curriculum are mediated by changes in self efficacy, self regulation, and time perspective and orientation, whereby the skills developed in the sessions enable children to make more accurate decisions on the likely immediate short- and long-term consequences of different types of alcohol use, and to develop (and adhere to) personal and group strategies to reduce harm experienced by the recipients' own and others' alcohol use. These changes will be reinforced and supported by changes in family-based skills.
The parental component is a brief intervention comprising a short standardised presentation delivered by a trained facilitator at school parent evenings. The presentation includes information on alcohol prevalence in young people, corrects parents' (under)estimates of youth drinking, and highlights the importance of setting strict family rules around alcohol. The presentation is followed by a brief discussion on family rules, and followed up by a leaflet providing a summary of the key information from the evening.
The control group participants will receive questionnaires only and will continue with the normal curriculum within their school. Exposure to drug, alcohol and other health education delivered as part of the curriculum will be monitored in all schools.
Previous interventions:
STAMPP is a UK adaptation of the Australian developed Schools Alcohol Harm Reduction Programme (SHAHRP) with the inclusion of a parental component (Talking About Tough Issues (TATI)) that is delivered (staggered introduction) from the beginning of Phase 1 of the classroom intervention.
Phase 1 is delivered when pupils are in year 10 (age 13-14), coinciding with the onset of alcohol use for many children, and phase 2 in year 11 (age 14-15), when alcohol use becomes more established. Phase 1 consists of six sessions (with 16 activities) and phase 2 consists of four sessions (with 10 activities). Each lesson uses skills-based activities and individual and small group discussions to emphasise the identification of alcohol-related harm and the development of harm reduction strategies. Interactive involvement is a key feature of the sessions.
Based on previous work it is hypothesised that changes in alcohol outcomes associated with the classroom curriculum are mediated by changes in self efficacy, self regulation, and time perspective and orientation, whereby the skills developed in the sessions enable children to make more accurate decisions on the likely immediate short and long term consequences of different types of alcohol use, and to develop (and adhere to) personal and group strategies to reduce harm experienced by the recipients' own and others' alcohol use. These changes will be reinforced and supported by changes in family based skills.
The parental component to be tested will be an adapted form of the Talking to Children about Tough Issues (TATI), a locally developed (Northern Ireland), evidence based (social interaction/development models of parenting) programme that takes place over three two hour long sessions and is targetted at parents/carers of intervention children. Through a series of supported activities, parents/carers are encouraged to develop general strategies for reducing conflict, to pursue reflective listening, and to help establish authoritative family rules on behaviours such as alcohol use.
The control group participants will receive questionnaires only and will continue with the normal curriculum within their school. Exposure to drug, alcohol, and other health education delivered as part of the curriculum will be monitored in all schools.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Current primary outcome measures as of 17/02/2015:
1. Alcohol consumption (defined as self-reported consumption of ≥6 units in a single episode in the previous 30 days for males and ≥4.5 units for females) in school pupils (school year 9/S2 in the academic year 2012/2013) at + 33 months (T3) from baseline. This will be dichotomised at never/one or more occasions.
2. Alcohol-related harms as measured by the number of self-reported harms (harms caused by own drinking) in school pupils (school year 9/S2 in the academic year 2012/2013) at +33 months (T3) from baseline
Previous primary outcome measures from 25/11/2013 to 17/02/2015:
To ascertain the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (frequency of consuming >5 drinks in a single episode in the previous 30 days) in second form pupils (aged at least 13 on 01/09/2012) at + 18 months after the intervention
Original primary outcome measures:
1. Period prevalence of alcohol use - self-reported alcohol use in lifetime, last year and previous month
2. Amount and frequency of episodic alcohol use - number of drinks in 'typical' and last use episode, frequency of consuming >5 drinks in a single episode in the previous 30 days
3. The age of alcohol initiation - age at which a whole drink of alcohol was first consumed, not just a sip or a shared drink
Secondary outcome measures
Current secondary outcome measures as of 17/02/2015:
1. Alcohol consumption (defined as self-reported consumption of ≥6 units in a single episode in the previous 30 days for males and ≥4.5 units for females) in school pupils (school year 9/S2 in the academic year 2012/2013) at + 24 months (T2) from baseline. This will be dichotomised at never/one or more occasions.
2. Alcohol consumption (self-reported alcohol use in lifetime, last year and previous month; number of drinks in ‘typical’ and last use episodes; age of alcohol initiation, unsupervised drinking) in school pupils (school year 9/S2 in the academic year 2012/2013), at +24 (T2) months and + 33 (T3) months.
3. Alcohol-related harms as measured by self-reported harms caused by own drinking at +24 months (T2), and self-reported harms caused by the drinking of others at +24 (T2) months and + 33 (T3) months, in school pupils (school year 9/S2 in the academic year 2012/2013).
Current secondary outcome measures from 25/11/2013 to 17/02/2015:
1. To ascertain the effectiveness and cost-effectiveness of STAMPP in reducing alcohol consumption (frequency of consuming >5 drinks in a single episode in the previous 30 days) in second form pupils (aged at least 13 on 01/09/2012) at + 6 months after the intervention.
2. To ascertain the effectiveness of STAMPP in reducing alcohol consumption (self-reported alcohol use in lifetime, last year and previous month; number of drinks in 'typical' and last use episodes; age of alcohol initiation, unsupervised drinking) in second form pupils (aged at least 13 on 01/09/2012) at + 6 months and + 18 months after the intervention.
3. To ascertain the effectiveness of STAMPP in reducing alcohol-related harms as measured by health service utilisation and self-reported harms (harms caused by own drinking and that of others) in second form pupils (aged at least 13 on 01/09/2012) at + 6 months and + 18 months after the intervention.
Original secondary outcome measures:
1. Alcohol knowledge and attitudes
2. Harm cause by own and others' alcohol use
3. Un/supervised alcohol use - prevalence of drinking with peers with or without the supervision of parents/guardians
Overall trial start date
01/11/2011
Overall trial end date
31/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 17/02/2015:
Male and female school pupils (school year 9/S2 in the academic year 2012/2013) and their parents/carers, attending post primary secondary schools in Northern Ireland and Glasgow/Inverclyde Local Authorities.
Previous inclusion criteria from 25/11/2013 to 17/02/2015:
Male and female school children (second year post primary; aged 13/14) and their parents/carers, attending post-primary secondary schools in Northern Ireland and Glasgow/Inverclyde Local Authorities.
Original inclusion criteria:
Male and female school children (Year 10; aged 13/14) and their parents/carers, attending post-primary secondary schools in Northern Ireland and Glasgow.
Participant type
Mixed
Age group
Mixed
Gender
Both
Target number of participants
10,000 pupils in 105 schools
Participant exclusion criteria
1. Pupils not in the specified school year and ages
2. Pupils in non mainstream and vocational education (e.g. pupil referral units, further education colleges)
3. Pupils with special educational needs are excluded as the intervention materials have not been developed for use with this population
Recruitment start date
01/11/2011
Recruitment end date
01/01/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Liverpool John Moores University
Liverpool
L3 2ET
United Kingdom
Trial participating centre
Oxford Brookes University
Gipsy Lane
Headington
Oxford
OX3 0BP
United Kingdom
Trial participating centre
University of Liverpool
Liverpool
L69 3BX
United Kingdom
Trial participating centre
Queen's University Belfast
University Road
Belfast
BT7 1NN
United Kingdom
Trial participating centre
Northern Ireland Clinical Trials Unit
1st Floor Elliott Dynes Building
The Royal Hospitals
Grosvenor Road
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Liverpool John Moores University (UK)
Sponsor details
Research Support Office
Kingsway House
Hatton Garden
Liverpool
L3 2AJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Public Health Research Programme
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28406601
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29525770