A factorial randomised controlled trial to examine the potential effect of a text-message based intervention on reducing adolescent susceptibility to e-cigarette use: A study protocol

Abstract

ABSTRACTIntroductionAdolescent e-cigarette use, globally and within Australia, has increased in recent years. In response, public health agencies have called for the development of education and communication programmes targeting adolescents. Despite such recommendations, few rigorous evaluations of such interventions currently exist. The main objective of this study is to examine the potential effect of a text-message intervention targeting parents and adolescents on adolescent susceptibility to e-cigarette use (e.g. intentions towards using e-cigarettes). Secondary objectives are to: (1) examine the effect of the intervention on adolescent e-cigarette and combustible tobacco use; and (2) examine the acceptability of the intervention.Methods and analysisA randomised controlled trial employing a 2x2 factorial design will be conducted with parent-adolescent dyads (aged 12-15 years). Dyads will be randomly allocated to one of four arms: Arm 1 - a text-message intervention delivered to adolescents only; Arm 2 – a text- message intervention delivered to the parents of adolescents only; Arm 3 – a text-message intervention delivered to both the parents and adolescents; and Arm 4 - an information only control, consisting of an e-cigarette factsheet provided to parents only. Participant recruitment commenced in April 2023 with the aim to recruit 120 parent-adolescent dyads. Data collection to assess study outcomes will occur at baseline, 6-, 12- and 24-months post the commencement of the intervention. The primary endpoint will be 6-month follow-up. The primary outcome will be adolescent susceptibility to e-cigarette use, assessed using validated items. Analyses of trial outcomes will be undertaken under an intention-to-treat framework, with all participants included in the analysis in the group they were allocated.Ethics and disseminationEthics approval has been obtained from the University of Newcastle Human Research Ethics Committee (H-2022-0340). Findings will be disseminated in peer-reviewed journals and at conferences.Trial registrationProspectively registered with Australia New Zealand Clinical Trials Registry (ACTRN12623000079640).STRENGTHS AND LIMITATIONSThis study will employ a rigorous factorial randomised controlled trial design to test the effectiveness of a text-message based intervention;This study will contribute to the limited existing evidence base, with no randomised controlled trials aiming to prevent adolescent e-cigarette use currently published yet several underway;Selection bias may occur if adolescents who are highly susceptible to e-cigarette use refuse to participate in the study.