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一项基于短信干预的青少年电子烟使用易感性研究的析因随机对照试验:研究方案

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.

机构信息

Hunter New England Population Health, Hunter New England Local Health District, Wallsend, New South Wales, Australia

School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.

出版信息

BMJ Open. 2024 Aug 17;14(8):e083251. doi: 10.1136/bmjopen-2023-083251.

Abstract

INTRODUCTION

Adolescent 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 (eg, 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 ANALYSIS

A randomised controlled trial employing a 2×2 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 March 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 DISSEMINATION

Ethics approval has been obtained from the human research ethics committee of the University of Newcastle (H-2022-0340). Findings will be disseminated in peer-reviewed journals and at conferences.

TRIAL REGISTRATION NUMBER

The trial was registered prospectively with Australian New Zealand Clinical Trials Registry (ACTRN12623000079640).

摘要

简介

近年来,青少年使用电子烟的现象在全球范围内有所增加,在澳大利亚也是如此。为应对这一现象,公共卫生机构呼吁针对青少年制定教育和宣传计划。尽管有这样的建议,但目前很少有针对这些干预措施的严格评估。本研究的主要目的是检验针对父母和青少年的短信干预措施对青少年易感性电子烟使用(例如使用电子烟的意图)的潜在影响。次要目标是:(1)检验干预措施对青少年电子烟和可燃烟草使用的影响;(2)检验干预措施的可接受性。

方法和分析

本研究将采用 2×2 析因设计的随机对照试验,对父母-青少年对子(年龄 12-15 岁)进行研究。对子将随机分配到以下四个组中的一组:第 1 组-仅向青少年发送短信干预;第 2 组-仅向青少年的父母发送短信干预;第 3 组-同时向青少年及其父母发送短信干预;第 4 组-仅向父母提供信息的对照组,包括提供给父母的电子烟事实手册。参与者招募于 2023 年 3 月开始,目标是招募 120 对父母-青少年对子。在干预开始后,将在基线、6、12 和 24 个月时收集数据以评估研究结果。主要终点是 6 个月随访。主要结果是青少年对电子烟使用的易感性,使用经过验证的项目进行评估。试验结果分析将在意向治疗框架下进行,所有参与者均纳入他们被分配的组进行分析。

伦理与传播

纽卡斯尔大学人类研究伦理委员会已批准本研究(H-2022-0340)。研究结果将在同行评议的期刊和会议上发表。

试验注册号

本试验在澳大利亚和新西兰临床试验注册中心(ACTRN12623000079640)进行了前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f59c/11331865/2bc378bebcb6/bmjopen-14-8-g001.jpg

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