Efficacy of a mobile phone-based life-skills training program for substance use prevention among adolescents: study protocol of a cluster-randomised controlled trial.

BACKGROUND: Life-skills trainings conducted within the school curriculum are effective in preventing the onset and escalation of substance use among adolescents. However, their dissemination is impeded due to their large resource requirements. Life-skills training provided via mobile phones might represent a more economic and scalable approach. The main objective of the planned study is to test the efficacy of a mobile phone-based life-skills training to prevent substance use among adolescents within a controlled trial. METHODS/DESIGN: The efficacy of a mobile phone-based life-skills training to prevent substance use among adolescents will be tested in comparison to an assessment only control group, within a cluster-randomised controlled trial with two follow-up assessments after 6 and 18 months. The fully automated program is based on social cognitive theory and addresses self-management skills, social skills, and substance use resistance skills. Participants of the intervention group will receive up to 4 weekly text messages over 6 months in order to stimulate (1) positive outcome expectations, e.g., on using self-management skills to cope with stress, (2) self-efficacy, e.g., to resist social pressure, (3) observational learning, e.g. of interpersonal competences, (4) facilitation, e.g., of strategies to cope with negative emotions, and (5) self-regulation, e.g., by self-monitoring of stress and emotions. Active program engagement will be stimulated by interactive features such as quiz questions, message- and picture-contests, and integration of a friendly competition with prizes in which program users collect credits with each interaction. Study participants will be 1312 students between the ages of 14 and 16 years from approximately 100 secondary school classes. Primary outcome criteria will be problem drinking according to the short form of the Alcohol Use Disorders Identification Test and cigarette smoking within the last 30 days preceding the follow-up assessment at month 18. DISCUSSION: This is the first study testing the efficacy of a mobile phone-based life-skills training for substance use prevention among adolescents within a controlled trial. Given that this intervention approach proves to be effective, it could be easily implemented in various settings and would reach large numbers of young people in a cost-effective way. TRIAL REGISTRATION: ISRCTN41347061 (registration date: 21/07/2018).

Efficacy of an internet-based self-help intervention to reduce co-occurring alcohol misuse and depression symptoms in adults: study protocol of a three-arm randomised controlled trial.

INTRODUCTION: In the general population, alcohol use disorder and depression more often occur together than any other combination of a mental illness with a substance use disorder. It is important to have a cost-effective intervention that is able to reach at-risk individuals in the early stages of developing alcohol use disorders and depression disorders. METHODS AND ANALYSIS: This paper presents the protocol for a 3-arm multicentre randomised controlled trial (RCT) to test the efficacy and cost-effectiveness of the combined internet-based self-help intervention Take Care of You (TCOY) to reduce alcohol misuse and depression symptoms in comparison with a waiting list control group and a comparable intervention focusing on problematic alcohol use only. The active interventions consist of modules designed to reduce alcohol use, based on the principles of motivational interviewing and methods of cognitive behavioural therapy, together with additional modules in the combined study arm to reduce symptoms of depression. Data will be collected at baseline, as well as at 3 and 6 months postrandomisation. The primary outcome is the quantity of alcohol used in the past 7 days. A number of secondary outcome measures will be studied. These include the Centre of Epidemiologic Studies of Depression Scale (CES-D) and a combined measure with the criteria of values below the cut-off for severe alcohol use disorder and for CES-D. Data analysis will follow the intention-to-treat principle using (generalised) linear mixed models. In order to investigate the interventions' cost-utility and cost-effectiveness, a full economic evaluation will be performed. ETHICS AND DISSEMINATION: This RCT will be executed in compliance with the Helsinki Declaration and has been approved by 2 local Ethics Committees. Results will be reported at conferences and in peer-reviewed publications. Participant-friendly summaries of trial findings will be published on the TCOY websites. TRIAL REGISTRATION NUMBER: ISRCTN10323951.