Developing and Evaluating a Low-intensity Secondary Theory-based Chatbot Intervention to Reduce Common Digital Addictions, Sedentary Behaviors and Mental Distress Among Adolescents: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Composite score of IGD and SMA
研究概览
简要总结
The goal of the study is to investigate the efficacy of a secondary low-intensity stage of change (SoC) and motivational interviewing (MI)-based Chatbot-assisted intervention in reducing digital addictions in adolescents with Internet gaming disorder (IGD) and/or social media addiction (SMA) by conducting a RCT.
Hypothesis: The intervention group will show a greater reduction in rates of IGD and/or SMA at post-treatment and 3-month follow-up than the control group.
Design and subjects: A two-armed RCT between the intervention group and psycho-educational control group for adolescents aged 10-19 with excessive screen time. Screening, baseline, post-programme, and 3-month follow-up evaluations will be conducted.
Participants will:
Be randomly assigned to online brief intervention or psycho-educational control
Complete questionnaires evaluating 1 ) Primary outcomes (IGD, SMA), 2) Secondary outcomes (sedentary lifestyle, mental distress, quality of life, eHealth literacy) and 3) Mediators/mechanisms (autonomy, competence)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students at grades 5-6 in primary schools or grades 7-12 in secondary schools,
- •Positive screening results of IGD and/or SMA) based on the validated screening tools
- •Using smartphone or Internet on a daily base, 4) students' and parental consent,
- •Chinese speaking.
排除标准
- •Current use of any psychotropic medication.
研究组 & 干预措施
Control
Participants will receive educational but not SoC and MI-based materials about excessive digital use, IGD, and SMA. Such psycho-educational interventions are widely used in behavioral/mental health promotion and have been demonstrated to be effective in increasing knowledge and awareness of behavioral and mental problems. Based on a comprehensive literature review and our previous psycho-educational programs for behavioral/mental health promotion, the research team will design the psycho-educational materials. Themes include definitions, factors, and health consequences of excessive digital use, IGD, and SMA, information on healthy lifestyles, self-regulation skills, and help-seeking resources.
干预措施: Control (Behavioral)
Chatbot
The intervention includes five modules based on the five stages of Stages of change. Chatbots will build up a rapport with the participants, monitor their stage with a few simple questions based on previous Stages of Change studies, and provide stage-tailored packages of response, advice, and feedback (one of the five modules) accordingly to enhance their motivation and self-efficacy each week. For those who click 'yes' to a question assessing the first stage of change (PC), Chatbot will make a record and automatically ask questions assessing the next stage; for those who click 'no', Chatbot will automatically send them the module corresponding to their SoC via WhatsApp. Each module will take 10-15 minutes. In total, it will take 1 hour to complete all the modules.
干预措施: Chatbot (Behavioral)
结局指标
主要结局
Composite score of IGD and SMA
时间窗: From enrollment to end of follow-up at 3 months.
Composite outcome of IGD score and SMA score: we define a simple composite as the sum of the two outcomes. Because each outcome measure uses a different scale and has different statistical properties, we will standardize the two variables (i.e., scores of IGD and SMA) first, and then combine the two standardized scores of the outcomes into a composite.
Internet gaming disorder (IGD)
时间窗: From enrollment to the end of follow-up at 3 months
IGD symptoms are assessed using the Nine-Item Internet Gaming Disorder Scale-Short Form (IGDS9-SF) consists of nine questions that assess IGD symptoms, including preoccupation, tolerance, withdrawal, unsuccessful attempts to limit gaming, deception or lies about gaming, loss of interest in other activities, use despite knowledge of harm, use for escape or relief of negative mood, and harm. The response options for each item include "yes=1" and "no=0". The overall score of the scale ranges from 0 to 9, with a higher score implying a higher level of IGD symptoms. Participants with score ≥ 5 will be classified as having probable IGD.
Social media addiction (SMA)
时间窗: From enrollment to end of follow-up at 3 months
SMA is defined as excessive use of social media with the addictive symptoms like mood modification, salience, tolerance, withdrawal symptoms, conflict, and relapse. The symptoms of SMA will be measured by the 6-item Bergen Social Media Addiction Scale (BSMAS) based on the six core components of addictive behaviors, including cognitive salience, tolerance, mood modification, difficulty in regulating use, withdrawal, and interference with role performance. The items are rated using a Likert type scale ranging between 1 (very rarely) and 5 (very often). A higher sum score in the BSMAS indicates a greater likelihood of being at risk of developing social media addiction. A cut-off score over 19 indicates probable SMA.
次要结局
- Sedentary lifestyle(From enrollment to end of 3 months follow-up)
- Entertainment screen time(From enrollment to end of follow-up at 3 months)
- Health-related Quality of life(From enrollment to end of follow-up at 3 months)
- Mental distress(From enrollment to end of follow-up at 3 months)
- eHealth literacy(From enrollment to end of follow-up at 3 months)
研究者
Dr. Xue YANG
Assistant Professor
Chinese University of Hong Kong