Effects of Reducing Screen Media Use on Mental Health, Sleep, Physical Activity, Heart Rate Variability, and Behavioral Patterns in Peer-groups of Young People: A Study Protocol for a Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 240
- 主要终点
- Change in mental wellbeing on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
研究概览
简要总结
The purpose of the PeerScreen trial is to investigate whether reducing screen media use affects mental health, social interaction, sleep, physical activity, heart rate variability, and behavioral patterns in young people aged 13 to 24 years. The primary question the trial aims to answer is:
Does reducing screen media use over a 4-week period improve mental health among young people?
Researchers will compare a screen media reduction intervention with a control condition in which participants continue their usual screen media use to determine whether reducing screen media use leads to improvements in mental health.
Participants will:
- be allocated to either a 4-week screen media reduction intervention or a control condition
- complete a study protocol including questionnaire-based assessments, daily self-reports, and objective monitoring of screen media use, sleep, physical activity, heart rate variability, social interactions, and geolocation
详细描述
The PeerScreen trial is a parallel-group cluster-randomized controlled trial in which peer groups of adolescents and young adults aged 13-24 years are randomized to either a four-week screen media reduction intervention or a control condition. Random allocation of each peer group will occur after completion of a 14-day baseline assessment protocol. Randomization will be conducted using computer-generated block randomization (block sizes 2-6), stratified by mean peer group age (<18 vs. ≥18 years). In practice, a researcher will log in to an online platform and click "randomize," thereby ensuring allocation concealment.
Participants in the intervention group will be instructed to reduce smartphone use to one hour per day, limit television, computer, and tablet use to 14 hours per week, and keep screen media devices outside the bedroom.
The target sample is 80 peer groups (2-6 peers per group) of adolescents (13-17 years) and young adults (18-24 years), to be recruited via a separate survey study. This survey will be conducted in classes across secondary and higher educational institutions (e.g., secondary schools, high schools, vocational schools, university colleges, and universities) and will describe screen media behaviors among Danish youth. Before administration of the survey, the research team will introduce the PeerScreen trial in each class. At the end of the survey, students will be asked whether they are interested in participating in an experimental study and whether the research team may contact them for follow-up. Written information about the experiment will be provided to interested students during classroom visits and distributed via the school and its online platforms, along with a registration link, after the visits. This procedure will allow students to express interest at a later stage if preferred.
Data collection will combine questionnaires on mental health and well-being, daily reports of mood, sleepiness, and social interactions, and objective monitoring of screen media use, sleep, physical activity, and heart rate variability using a custom application and a wearable device. Bluetooth beacon data will be used to assess social interactions objectively, and geolocation data will be used to provide contextual information about these interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must have at least 2 hours/day of self-reported smartphone use during leisure time (data from the survey study)
- •Members of each participant's household must be willing to support the participant in adhering to the prescribed intervention (data from recruitment interview)
- •Participants must have enough discretionary leisure time for possible in-person activities on a weekly basis throughout the study period (verified at the information meeting)
排除标准
- •Participants with no smartphone will be excluded (data from recruitment interview)
- •Participants with no social media profiles will be excluded (data from recruitment interview)
- •Participants who currently participate in other experimental studies will be excluded (data from recruitment interview)
- •Participants who have been hospitalized or prescribed sick leave within the past 3 months due to a mental illness will be excluded (data from recruitment interview)
研究组 & 干预措施
Screen media reduction
Peer groups randomized to the intervention will undergo a four-week screen media reduction.
干预措施: Screen media reduction (Behavioral)
Usual screen media use (control)
Participants allocated to the control group will be asked not to change their use of screen media devices and continue with their usual screen media behaviors. At the randomization meeting, if a peer group is allocated to the control condition, a researcher will explain the importance of the control group for ensuring the validity of the trial, with the aim of keeping these groups motivated and engaged. Participants in the control group will be offered the screen media reduction intervention after completing the long-term follow-up. Accordingly, they will function as a waitlist control group, although no outcome data will be collected during their subsequent intervention period.
结局指标
主要结局
Change in mental wellbeing on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
时间窗: From baseline (day 1) to post-intervention (day 42).
Self-reported mental well-being assessed as change in total score on the 14-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS). Total scores range from 14 to 70 points. Higher scores indicate better mental well-being.
次要结局
- Change in total weekly duration of face-to-face social interaction with peer-group members measured by Bluetooth Low Energy (BLE) beacon proximity events(From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period)
- Change in average weekly frequency of self-reported face-to-face social interactions with non-household, non-peer individuals(From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period)
- Change in average nightly total sleep time measured by Garmin Venu 4(From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.)
- Change in average daily step count measured by Garmin Venu 4(From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period)
研究者
Anders Groentved
Professor
University of Southern Denmark