Baclofen may be an effective treatment option for patients with ALD. However, given the profile of adverse events, the role for this medication might be best limited to specialist services.Declaration of interestNone.

Background Anxiety, mood, and substance use disorders have significant social and economic impacts, which are largely attributable to their early age of onset and chronic disabling course. Therefore, it is critical to intervene early to prevent chronic and debilitating trajectories. Objective This paper describes the study protocol of a CONSORT (Consolidated Standards of Reporting Trials)-compliant randomized controlled trial for evaluating the effectiveness of the Mind your Mate program, a mobile health (mHealth) peer intervention that aims to prevent mental health (focusing on anxiety and depression) and substance use problems in adolescents. Methods Participants will consist of approximately 840 year 9 or year 10 students (60 students per grade per school) from 14 New South Wales high schools in Sydney, Australia. Schools will be recruited from a random selection of independent and public schools across the New South Wales Greater Sydney Area by using publicly available contact details. The intervention will consist of 1 introductory classroom lesson and a downloadable mobile app that will be available for use for 12 months. Schools will be randomly allocated to receive either the mHealth peer intervention or a waitlist control (health education as usual). All students will be given web-based self-assessments at baseline and at 6- and 12-month follow-ups. The primary outcomes of the trial will be the self-reported use of alcohol and drugs, anxiety and depression symptoms, knowledge about mental health and substance use, motives for not drinking, and willingness to seek help. Secondary outcomes will include positive well-being, the quality of life, and the impact of the COVID-19 pandemic. Analyses will be conducted using mixed-effects linear regression analyses for normally distributed data and mixed-effects logistic regression analyses for categorical data. Results The Mind your Mate study was funded by an Australian Rotary Health Bruce Edwards Postdoctoral Research Fellowship from 2019 to 2022. Some of the development costs for the Mind your Mate intervention came from a seed funding grant from the Brain and Mind Centre of the University of Sydney. The enrollment of schools began in July 2020; 12 of 14 schools were enrolled at the time of submission. Baseline assessments are currently underway, and the first results are expected to be submitted for publication in 2022. Conclusions The Mind your Mate study will generate vital new knowledge about the effectiveness of a peer support prevention strategy in real-world settings for the most common mental disorders in youth. If effective, this intervention will constitute a scalable, low-cost prevention strategy that has significant potential to reduce the impact of mental and substance use disorders. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12620000753954; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=379738&isReview=true International Registered Report Identifier (IRRID) DERR1-10.2196/26796

Background Digital technologies and mobile interventions are possible tools for prevention initiatives to target the substantial social and economic impacts that anxiety, mood, and substance use disorders have on young people. Objective This paper described the design and development of the Mind your Mate program, a smartphone app and introductory classroom lesson enhancing peer support around the topics of anxiety, depression, and substance use for adolescents. Methods The development of Mind your Mate was an iterative process conducted in collaboration with adolescents (n=23), experts, school staff, and software developers. The development process consisted of 3 stages: scoping; end-user consultations, including a web-based survey and 2 focus groups with 23 adolescents (mean age 15.9, SD 0.6 years); and app development and beta-testing. Results This process resulted in a smartphone peer support app and introductory classroom lesson aimed at empowering adolescents to access evidence-based information and tools to better support peers regarding mental health and substance use–related issues. The program contains links to external support services and encourages adolescents to reach out for help if they are concerned about themselves or a friend. Conclusions The Mind your Mate program was developed in collaboration with a number of key stakeholders in youth mental health, including adolescents. The resulting program has the potential to be taken to scale to aid prevention efforts for youth mental health and substance use. The next step is to conduct a randomized controlled trial testing the feasibility, acceptability, and efficacy of the program.

BACKGROUND While it is well known that adolescents frequently turn to their friends for support around mental health and substance use problems, there are currently no evidence-based digital programs to support them to do this. OBJECTIVE To evaluate the efficacy of the Mind your Mate program, a digital peer support program, in improving mental health symptoms, reducing the uptake of substance use, and increasing help-seeking. The Mind your Mate program consists of an online 40-minute classroom lesson and a companion smartphone mobile application (app). The active control group received school-based health education as usual. METHODS A cluster randomized controlled trial (RCT) was conducted with 12 secondary schools and 166 students (mean age=15.3 years, SD=0.41, 46% female, 80% born in Australia). Participants completed self-reported questionnaires assessing symptoms of mental health (depression, anxiety, and psychological distress), substance use (alcohol and other drug use) and help-seeking measures at baseline, 6- and 12-month follow-up. RESULTS Students who received the Mind your Mate program had reduced growth in depressive symptoms over a 12-month period, compared to controls (b=-1.86, 95% CI=3.73 – 0.02). Promisingly, anxiety symptoms decreased among students in the intervention group; however, these reductions did not meet statistical significance thresholds. No significant differences were observed in relation to psychological distress or help-seeking. CONCLUSIONS A novel digital health intervention, the Mind your Mate program, reduced depression symptoms in adolescents over 12-months compared to a control condition. While the current results are encouraging there is a need to continue to refine, develop and evaluate innovative applied approaches to the prevention of mental disorders in real-world settings. CLINICALTRIAL The study was prospectively registered on the Australian New Zealand Clinical Trials Registry (#ACTRN12620000753954). https://www.anzctr.org.au/ INTERNATIONAL REGISTERED REPORT RR2-10.2196/26796