This article was originally published here
JMIR Res Protoc. 2021 Jul 30;10(7):e26796. doi: 10.2196/26796.
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.