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临床试验/NCT07344142
NCT07344142已完成不适用

Improving Digital Wellbeing in Saudi Adolescents: Cluster-randomized Trial

Johns Hopkins Bloomberg School of Public Health1 个研究点 分布在 1 个国家目标入组 2,600 人开始时间: 2026年1月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
2,600
试验地点
1
主要终点
Weekday leisure screen-time hours assessed by survey

研究概览

简要总结

Background: In Saudi Arabia, the rapid expansion of digital technology use-particularly among adolescents-has raised growing concerns about internet addiction and its impact on mental health and overall wellbeing. Building on formative work including national surveys, stakeholder interviews, and pilot testing, there is now a pressing need to rigorously evaluate interventions that can promote healthy digital habits among youth.

Study aims/objective: This study aims to evaluate the effectiveness of a school-based digital wellbeing intervention, with and without a supplemental parent engagement component, using a cluster randomized controlled trial design. The primary objective is to determine whether exposure to the student curriculum alone or in combination with a parent-focused intervention improves digital literacy, technology use behaviors, and psychosocial wellbeing among high school students. Secondary objectives include assessing changes in parent-child communication and parental attitudes toward digital media use.

Methods: Twenty (20) high schools across Qassim and Riyadh regions in Saudi Arabia will be randomly assigned to one of two study arms: (1) treatment as usual (TAU) will receive the Ministry of Education (MOE) Digital Wellbeing Unit that is implemented in 12th grad as part of the Digital Citizenship Curriculum and a brief self-paced online teacher training, or (2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training. Approximately 125 students per school (~2,500 total) will complete surveys before and after the intervention period, assessing digital media habits, wellbeing, and communication patterns. Parent surveys will be administered in the enhanced arm to assess intervention engagement and parenting practices. Surveys with teachers will assess motivation and self-efficacy in delivering the digital wellbeing unit and fidelity of delivery.

Results: The study will generate evidence on the efficacy of school- and family-based strategies for improving adolescent digital wellbeing in the Saudi context. It will also provide insight into mechanisms of change, including the role of parental involvement in shaping adolescent digital habits.

Conclusion: Findings from this cluster randomized trial will inform national digital wellbeing policy and practice, offering a scalable model for youth-targeted behavioral health interventions in Saudi Arabia and similar settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • The study will include students enrolled in Grade 12 at participating high schools that are randomly assigned to one of the study arms.
  • In addition, parents or legal guardians of these students will be eligible to participate in the parent-focused component of the intervention if the student is assigned to the enhanced curriculum group.

排除标准

  • Students and parents will be excluded from the study if the students and parents do not provide assent or consent to participate, in accordance with ethical guidelines.

研究组 & 干预措施

Treatment as usual

Active Comparator

(1) treatment as usual (TAU) will receive the Ministry of Education (MOE) Digital Wellbeing Unit that is implemented in 12th grade as part of the Digital Citizenship Curriculum and a brief self-paced online teacher training

干预措施: Digital Wellbeing Unit (Behavioral)

Treatment as usual

Active Comparator

(1) treatment as usual (TAU) will receive the Ministry of Education (MOE) Digital Wellbeing Unit that is implemented in 12th grade as part of the Digital Citizenship Curriculum and a brief self-paced online teacher training

干预措施: Online Teacher Training (Behavioral)

Enhanced treatment

Experimental

(2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training.

干预措施: Digital Wellbeing Unit (Behavioral)

Enhanced treatment

Experimental

(2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training.

干预措施: Parent WhatsApp Groups (Behavioral)

Enhanced treatment

Experimental

(2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training.

干预措施: Online Teacher Training (Behavioral)

结局指标

主要结局

Weekday leisure screen-time hours assessed by survey

时间窗: Baseline, pre-intervention, post-intervention (1 month)

Weekday (screen time for leisure)

次要结局

  • Social Media Disorder Scale(Baseline, pre-intervention, post-intervention (1 month))
  • Internet Gaming Disorder Scale-ShortForm (IGDS9-SF)(Baseline, pre-intervention, post-intervention (1 month))
  • Digital wellbeing knowledge 1 assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being knowledge 2 assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being attitudes assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being self-efficacy assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being behavior change 1 assessed by survey: notification-checking frequency(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being behavior change 2 assessed by survey: device use before sleep(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being behavior change 3 assessed by survey: engagement in non-digital activities(Baseline, pre-intervention, post-intervention (1 month))
  • Digital well-being behavior change 4 assessed by survey: use of apps or tools to monitor and manage digital habits(Baseline, pre-intervention, post-intervention (1 month))
  • Number of participants who upload phone screen shots of Screentime app(Baseline, pre-intervention, post-intervention (1 month))
  • Weekend leisure screen-time hours assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Weekday work/study screen-time hours assessed by survey(Baseline, pre-intervention, post-intervention (1 month))
  • Weekend work/study screen-time hours assessed by survey(Baseline, pre-intervention, post-intervention (1 month))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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