Title: Steps towards alcohol misuse prevention programme (STAMPP): a school and community based cluster randomised controlled trial
Funder: Department of Health (England)

Abstract: Steps towards alcohol misuse prevention programme (STAMPP)is a school and community based cluster randomised controlled trial. The hypothesis to be tested is: 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. Outcomes will be assessed using a variety of standardised and validated measures. The primary research objective is: •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 the 1st September 2012) at + 18 months after interventionSecondary research objectives are:•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 the 1st September 2012) at + 6 months after intervention.•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 age of alcohol initiation unsupervised drinking) in second form pupils (aged at least 13 on the 1st September 2012) at + 6 months and + 18 months after intervention.•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 the 1st September 2012) at + 6 months and + 18 months after intervention.And if shown to be effective:•To ascertain which components of STAMPP make it effective in reducing alcohol related harm in second form pupils (aged at least 13 on the 1st September 2012) at + 6 months and + 18 months after intervention.•To ascertain the behavioural and cognitive mediators of change (individual and family factors) that lead to the effectiveness of STAMPP in second form pupils (aged at least 13 on the 1st September 2012) at + 6 months and + 18 months after intervention.The primary end point of the study is 18 months post intervention. The secondary endpoint is 6 months post intervention.Description of the 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 alcohol-related parental 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 presents the Chief Medical Officer’s guidance on youth drinking 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 includes an introduction to the concepts involved in alcohol 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 are 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 setting.Methods: Setting 105 post primary schools in Northern Ireland and Glasgow/Inverclyde Local Authority AreasDesignA randomised controlled cluster trial comparing STAMPP vs alcohol education as normal for the reduction of hazardous and harmful alcohol drinking and alcohol related harmsInclusionMale and female school children (second form; pupils aged at least 13 on the 1st September 2012) and their parents/carers attending post-primary secondary schools in NI and Glasgow/Inverclyde Local Authority Areas.ExclusionPupils not in the specified school year and age group. Pupils in non mainstream and vocational education (e.g. pupil referral units further education colleges). Pupils with special educational needs are excluded at the discretion of teachers as the intervention materials have not been developed for use with this population.Analysis of primary outcomeThe initial outcome analysis will be an ITT such that all cases will be assessed regardless of intervention and intervention dosage. However as the study design is clustered (i.e. randomisation occurred at the school level) the lack of independency between individual cluster members must be taken into account to avoid underestimated standard errors (which inflate statistical significance). As a result this initial ITT analysis will be conducted at the cluster level using a summary measure and at the pupil level with test statistics adjusted for intracluster correlation.In addition to the initial ITT multivariate (regression) models will be estimated to examine the impact of covariates on intervention outcome. Baseline outcome measures will be included as covariates to allow for individual differences. Model estimates with standard errors that are robust to the non-normality and non-independence of observations will be computed (for example Mplus employs a sandwich estimator to compute robust standard errors under the TYPE=COMPLEX option). All prognostic variables will be eligible for inclusion in the covariate adjusted analysis. Variables that were stratified at randomisation will also be eligible for inclusion in the covariate adjusted model. Selected interaction terms will be tested (interaction between trial arm and gender region and alcohol consumption latent class). Where significant planned sub group analysis will be undertaken.Health Economic AnalysisA within-trial cost effectiveness analysis (CEA) will be undertaken to assess the cost-effectiveness of STAMPP compared with usual education in reducing heavy episodic (>5 drinks per episode) drinking in year 9 pupils at T3 (+ 6 months post phase 2) and then again at T4 (+ 18 months ). It will adhere to the National Institute for Health and Care Excellence (NICE) guide to methods of technology appraisal (NICE 2013) where appropriate. Consistent with the primary outcome of the study the primary economic effectiveness measure is the number of pupils who have experienced an episode of heavy drinking at + 18 months. The secondary economic effectiveness measure is the number of heavy drinking episodes at + 18 months. The latter will be calculated using data on the frequency of heavy drinking episodes in the previous 30 days collected at 4 time points over the 18 month study and follow-up period. The area under the curve method will be used to obtain a summary measure of heavy drinking episodes over this period. A societal perspective will be adopted for the analysis capturing resource use data related to each childs contact with the National Health Service (NHS) Personal Social Services (PSS) social services and criminal justice. Data on service use by all participants over the course of the study and 18 month follow up period will be collected using a bespoke instrument which incorporates items taken from the Client Service Receipt Inventory (CSRI) specifically adapted for childhood and items relating to the use of judicial services. The instrument includes an information page with definitions of some of the public services in case the students were unfamiliar with them. The instrument was designed with input from relevant professionals (e.g. educational psychologist social workers Scottish and Northern Irish teachers) and reviewed by a social researcher experienced in giving questionnaires to children and other health economists. Intervention costs will also be measured. These will include the costs associated with staff training delivery of the intervention travel and consumables. Timing:The study started 2011 and last for 53 months (end date March 2016). School recruitment was completed by May 2012. Phase 1 of the intervention was delivered in Autumn 2012 and Phase 2 in Autumn 2013. The parental component takes place in Autumn term 2013. Participants are surveyed at 4 time points; T1 (baseline) T2 (+6 months post phase 1) T3 (+6 months post phase 2) T4 (+18 months post phase 2).


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: STROKE;CANCER AND NEOPLASMS;CARDIOVASCULAR;ORAL AND GASTROINTESTINAL