Abstract
BackgroundEarly and excessive alcohol use is a significant threat to healthy development. Evidence supports the effectiveness of electronic alcohol interventions for young drinkers. However, effects are typically small and studies targeting under 18-year-olds are scarce. This trial is the first to evaluate the effectiveness of a single-session, brief, motivational, web-based intervention (ProWISE) plus weekly text-message-initiated individualised prompts (TIPs) in reducing alcohol consumption and alcohol-related harm among children and adolescents aged ≥ 12 years. TIPs are designed to decrease risky alcohol use by reaching youth in the contexts of their everyday lives and by providing individualised feedback on drinking intentions, actual drinking and succession in achieving personal goals for low-risk drinking or abstinence.Methods/DesignThe trial is part of the multicentre consortium ProHEAD testing e-interventions for mental health problems in children and adolescents. Participants in grades 6–13 aged ≥ 12 years will be recruited in schools which participate in ProHEAD (target N = 15,000). Main criterion for inclusion in the ProWISE-TIP trial is a positive screening for at-risk alcohol use in the CRAFFT-d questionnaire (target n = 1076). In a multicentre, four-arm, randomised controlled design the following groups will be compared: (A) web-based intervention plus TIPs for 12 weeks; (B) web-based intervention plus text-message-initiated assessment of alcohol consumption for 12 weeks; (C) web-based intervention only; and (D) alcohol-related psychoeducation. TIPs will be delivered shortly before and after high-risk situations for excessive alcohol use and will be tailored to age, gender, drinking motives and alcohol consumption. Study participants will be followed up at three, six and nine months in the ProWISE-TIP trial and at one and two years in the ProHEAD consortium. Primary outcome is alcohol use in the past 30 days at nine months after enrolment. Secondary outcomes are alcohol-related problems, co-occurring substance use, health service utilisation, mental health problems and quality of life.DiscussionTrial results will generate important evidence on how to enhance effectiveness of single-session, web-based alcohol interventions for youth. The ProWISE-TIP intervention, if effective, can be used as a stand-alone alcohol intervention or as an add-on to school-based or community-based alcohol prevention programs.Trial registrationGerman Clinical Trials Register, DRKS00014606 Registered on 20 April 2018.
Highlights
And excessive alcohol use is a significant threat to healthy development
Among 16- to 17-year-old boys, 37.1% report binge drinking in the past month (26.7% among girls) [3], indicating that a substantial proportion of the young population is at risk for experiencing short- and long-term negative consequences of risky alcohol use
We will integrate text-message-initiated individualised prompts (TIPs) following the initial delivery of the web-based, single-session, brief motivational intervention (ProWISE intervention) and test this version of the intervention in a randomised controlled trial (RCT). Main goals of this trial are: (1) development of a user-centred, time-efficient and youth-specific text-message-initiated technique for delivering highly individualised prompts assessing drinking intentions and actual alcohol use and providing individualised feedback; (2) pilot testing of feasibility and acceptability of the new intervention components (i.e. TIPs) and their refinement according to results from the pilot testing and evaluation of focus group interviews; and (3) evaluation of effectiveness of the TIPs as boosters for the ProWISE intervention in a four-arm randomised controlled design
Summary
Onset of alcohol use and excessive alcohol use is a major risk factor for a number of serious negative shortterm consequences and for chronification of harmful consumption patterns into adulthood [10]. Adolescents are hard to reach with prevention measures and they typically show little access to the help system [14,15,16] In this trial, we aim at developing a user-centred, youth-specific, fully automated, electronic alcohol intervention which has the potential to lower existing barriers for service utilisation and reaches populations of at-risk alcohol-consuming children and adolescents who are often underserved. We aim at developing a user-centred, youth-specific, fully automated, electronic alcohol intervention which has the potential to lower existing barriers for service utilisation and reaches populations of at-risk alcohol-consuming children and adolescents who are often underserved To our knowledge, this is the first trial to investigate effectiveness and cost-effectiveness of highly individualised, highfrequent booster messages as an add-on to a single-session, web-based, alcohol intervention in the target population of children and adolescents aged ≥ 12 years. Protocol Items: Recommendations for Interventions Trials; TA: Text-messageinitiated assessment; TIP: Text-message-initiated individualised prompt
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