Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium

Diestelkamp, Silke; Wartberg, Lutz; Kaess, Michael; Bauer, Stephanie; Rummel-Kluge, Christine; Becker, Katja; Eschenbeck, Heike; Salize, Hans-Joachim; Moessner, Markus; Baldus, Christiane; Arnaud, Nicolas; Thomasius, Rainer (2019). Effectiveness of a web-based screening and brief intervention with weekly text-message-initiated individualised prompts for reducing risky alcohol use among teenagers: study protocol of a randomised controlled trial within the ProHEAD consortium. Trials, 20(1), p. 73. BioMed Central 10.1186/s13063-018-3160-z

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BACKGROUND:
Early 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/DESIGN:
The 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.

DISCUSSION:
Trial 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 REGISTRATION:
German Clinical Trials Register, DRKS00014606 Registered on 20 April 2018.

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