Effectiveness of a universal, school-based, online programme for the prevention of anxiety, depression, and substance misuse among adolescents in Australia: 72-month outcomes from a cluster-randomised controlled trial.

BACKGROUND: The CSC study found that the universal delivery of a school-based, online programme for the prevention of mental health and substance use disorders among adolescents resulted in improvements in mental health and substance use outcomes at 30-month follow-up. We aimed to compare the long-term effects of four interventions-Climate Schools Combined (CSC) mental health and substance use, Climate Schools Substance Use (CSSU) alone, Climate Schools Mental Health (CSMH) alone, and standard health education-on mental health and substance use outcomes among adolescents at 72-month follow-up into early adulthood. METHODS: This long-term study followed up adolescents from a multicentre, cluster-randomised trial conducted across three states in Australia (New South Wales, Queensland, and Western Australia) enrolled between Sept 1, 2013, and Feb 28, 2014, for up to 72 months after baseline assessment. Adolescents (aged 18-20 years) from the original CSC study who accepted contact at 30-month follow-up and provided informed consent at 60-month follow-up were eligible. The interventions were delivered in school classrooms through an online delivery format and used a mixture of peer cartoon storyboards and classroom activities that were focused on alcohol, cannabis, anxiety, and depression. Participants took part in two web-based assessments at 60-month and 72-month follow-up. Primary outcomes were alcohol use, cannabis use, anxiety, and depression, measured by self-reported surveys and analysed by intention to treat (ie, in all students who were eligible at baseline). This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000723785), including the extended follow-up study. FINDINGS: Of 6386 students enrolled from 71 schools, 1556 (24·4%) were randomly assigned to education as usual, 1739 (27·2%) to CSSU, 1594 (25·0%) to CSMH, and 1497 (23·4%) to CSC. 311 (22·2%) of 1401 participants in the control group, 394 (26·4%) of 1495 in the CSSU group, 477 (37·%) of 1289 in the CSMH group, and 400 (32·5%) of 1232 in the CSC group completed follow-up at 72 months. Adolescents in the CSC group reported slower year-by-year increases in weekly alcohol use (odds ratio 0·78 [95% CI 0·66-0·92]; p=0·0028) and heavy episodic drinking (0·69 [0·58-0·81]; p<0·0001) than did the control group. However, significant baseline differences between groups for drinking outcomes, and no difference in the predicted probability of weekly or heavy episodic drinking between groups were observed at 72 months. Sensitivity analyses increased uncertainty around estimates. No significant long-term differences were observed in relation to alcohol use disorder, cannabis use, cannabis use disorder, anxiety, or depression. No adverse events were reported during the trial. INTERPRETATION: We found some evidence that a universal online programme for the prevention of anxiety, depression, and substance use delivered in early adolescence is effective in reducing the use and harmful use of alcohol into early adulthood. However, confidence in these findings is reduced due to baseline differences, and we did not see a difference in the predicted probability of drinking between groups at 72-month follow-up. These findings suggest that a universal prevention programme in adolescence is not sufficient to have lasting effects on mental health and substance use disorders in the long term. In addition to baseline differences, substantial attrition warrants caution in interpretation and the latter factor highlights the need for future long-term follow-up studies to invest in strategies to increase engagement. FUNDING: Australian National Health and Medical Research Council.

Evaluating a Peer-Support Mobile App for Mental Health and Substance Use Among Adolescents Over 12 Months During the COVID-19 Pandemic: Randomized Controlled Trial.

BACKGROUND: Although 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: The aim of this study was 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 a 40-minute web-based classroom lesson and a companion smartphone mobile app. The active control group received school-based health education as usual. METHODS: A cluster randomized controlled trial was conducted with 12 secondary schools and 166 students (mean age 15.3, SD 0.41 years; 72/166, 43.4% female; and 133/166, 80.1% 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 and at 6-month and 12-month follow-ups. RESULTS: Students who received the Mind your Mate program had greater reductions in depressive symptoms over a 12-month period than controls (b=-1.86, 95% CI -3.73 to 0.02; Cohen d=-0.31). Anxiety symptoms decreased among students in the intervention group; however, these reductions did not meet statistical significance thresholds. No differences were observed in relation to psychological distress or help-seeking. CONCLUSIONS: Small to moderate reductions in depression symptoms were observed among students allocated to receive the Mind your Mate intervention. Although the current results are encouraging, there is a need to continue to refine, develop, and evaluate innovative applied approaches for the prevention of mental disorders in real-world settings. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12620000753954; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000753954. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/26796.

Development of a Peer Support Mobile App and Web-Based Lesson for Adolescent Mental Health (Mind Your Mate): User-Centered Design Approach.

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.

A Mobile Peer Intervention for Preventing Mental Health and Substance Use Problems in Adolescents: Protocol for a Randomized Controlled Trial (The Mind Your Mate Study).

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.

Baclofen in the treatment of alcohol dependence with or without liver disease: multisite, randomised, double-blind, placebo-controlled trial.

BACKGROUND: There are no available medications for the management of alcohol dependence for patients with alcoholic liver disease (ALD).AimsTo conduct a multisite, double blind, placebo-controlled, randomised clinical trial of baclofen in the treatment of alcohol dependence, with or without liver disease (trial registration: ClinicalTrials.gov, NCT01711125). METHOD: Patients (n = 104) were randomised to placebo, baclofen 30 mg/day or 75 mg/day for 12 weeks. Primary outcomes included survival time to lapse (any drinking), relapse (≥5 drinks per day in men and ≥4 in women), and the composite outcome of drinks per drinking day, number of heavy drinking days, and percentage days abstinent. RESULTS: There was a significant effect of baclofen (composite groups) on time to lapse (χ2 = 6.44, P<0.05, Cohen's d = 0.56) and relapse (χ2 = 4.62, P<0.05, d = 0.52). A significant treatment effect of baclofen was observed for percentage days abstinent (placebo 43%, baclofen 30 mg 69%, baclofen 75 mg 65%; P<0.05). There was one serious adverse event (overdose) directly related to medication (75 mg). CONCLUSIONS: 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.