- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07344142
Improving Digital Wellbeing in Saudi Adolescents
Improving Digital Wellbeing in Saudi Adolescents: Cluster-randomized Trial
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Johannes Thrul
- Phone Number: +14433186633
- Email: jthrul@jhu.edu
Study Contact Backup
- Name: Nazmus Saquib
- Email: a.saquib@sr.edu.sa
Study Locations
-
-
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Buraidah, Saudi Arabia
- Recruiting
- Sulaiman Al Rahji University
-
Contact:
- Nazmus Saquib
- Email: a.saquib@sr.edu.sa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Treatment as usual
(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
|
(1) The student component utilizes the existing Digital Wellbeing Unit embedded within the national Digital Citizenship Curriculum, as implemented by the Saudi Ministry of Education.
This curriculum is delivered by classroom teachers over the course of approximately one month, typically as part of standard instruction during the academic term.
The content focuses on responsible digital media use, online safety, screen time awareness, and strategies for achieving digital balance.
All instructional materials and delivery methods align with Ministry guidelines and are integrated into the regular school schedule.
(3) Teachers in both arms will complete a brief self-paced online training (~45 minutes total) prior to delivering the Digital Wellbeing Unit.
The training introduces key digital wellbeing concepts, provides implementation guidance aligned with the Ministry of Education curriculum, and includes resources to support classroom delivery.
Completion will be monitored to ensure fidelity across schools.
|
|
Experimental: Enhanced treatment
(2) enhanced treatment including the MOE Digital Wellbeing Unit plus a WhatsApp-based intervention for parents and a brief self-paced online teacher training.
|
(1) The student component utilizes the existing Digital Wellbeing Unit embedded within the national Digital Citizenship Curriculum, as implemented by the Saudi Ministry of Education.
This curriculum is delivered by classroom teachers over the course of approximately one month, typically as part of standard instruction during the academic term.
The content focuses on responsible digital media use, online safety, screen time awareness, and strategies for achieving digital balance.
All instructional materials and delivery methods align with Ministry guidelines and are integrated into the regular school schedule.
(3) Teachers in both arms will complete a brief self-paced online training (~45 minutes total) prior to delivering the Digital Wellbeing Unit.
The training introduces key digital wellbeing concepts, provides implementation guidance aligned with the Ministry of Education curriculum, and includes resources to support classroom delivery.
Completion will be monitored to ensure fidelity across schools.
(2) The parental component, developed by the research team, is included in the enhanced intervention arm.
It consists of structured engagement through WhatsApp groups formed with parents of students enrolled in the intervention schools.
Parents in this group will receive daily messages for the duration of the curriculum delivery (approximately 4 weeks).
These messages will include infographics, short expert video lectures, and brief videos designed to reinforce the concepts taught in the student curriculum.
Content will focus on promoting healthy digital habits, improving communication between parents and children about technology use, and modeling appropriate digital behaviors at home.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weekday leisure screen-time hours assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Weekday (screen time for leisure)
|
Baseline, pre-intervention, post-intervention (1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Media Disorder Scale
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Social Media Disorder Scale: Score range from 9-45 with higher scores indicating higher degree of Social Media Disorder
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Internet Gaming Disorder Scale-ShortForm (IGDS9-SF)
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Internet Gaming Disorder Scale-ShortForm (IGDS9-SF): Score range from 9-45 with higher scores indicating higher degree of Internet Gaming Disorder
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Digital wellbeing knowledge 1 assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Knowledge regarding digital wellbeing topics covered in the curriculum; items were developed by the research team: Score range from 0-10 with higher scores indicating more digital wellbeing knowledge
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Digital well-being knowledge 2 assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Knowledge regarding digital wellbeing topics covered in the curriculum; items were developed by the research team: Score range from 3-15 with higher scores indicating more digital wellbeing knowledge
|
Baseline, pre-intervention, post-intervention (1 month)
|
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Digital well-being attitudes assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Attitudes regarding digital wellbeing topics covered in the curriculum; items were developed by the research team: Score range from 5-25 with higher scores indicating more favorable attitudes toward digital balance and healthy technology use
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Digital well-being self-efficacy assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Self-efficacy regarding digital wellbeing topics covered in the curriculum; items were developed by the research team: Score range from 5-25 with higher scores indicating stronger digital wellbeing self-efficacy
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Digital well-being behavior change 1 assessed by survey: notification-checking frequency
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Self-reported changes in digital media habits or wellbeing practices as a result of the intervention; items were developed by the research team: This item captures unnecessary notification-checking frequency with score range 1-5 and higher scores indicating worse digital wellbeing behavior.
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Digital well-being behavior change 2 assessed by survey: device use before sleep
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Self-reported changes in digital media habits or wellbeing practices as a result of the intervention; items were developed by the research team: This item captures avoiding device use before sleep with score range 1-5 and higher scores indicating better digital wellbeing behavior.
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Baseline, pre-intervention, post-intervention (1 month)
|
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Digital well-being behavior change 3 assessed by survey: engagement in non-digital activities
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Self-reported changes in digital media habits or wellbeing practices as a result of the intervention; items were developed by the research team: This item captures engagement in non-digital activities with score range 1-5 and higher scores indicating better digital wellbeing behavior.
|
Baseline, pre-intervention, post-intervention (1 month)
|
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Digital well-being behavior change 4 assessed by survey: use of apps or tools to monitor and manage digital habits
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Self-reported changes in digital media habits or wellbeing practices as a result of the intervention; items were developed by the research team: This item captures use of apps or tools to monitor and manage digital habits with score range 1-5 and higher scores indicating better digital wellbeing behavior.
|
Baseline, pre-intervention, post-intervention (1 month)
|
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Number of participants who upload phone screen shots of Screentime app
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
The investigators will explore feasibility of collecting objective data from students including screenshots of Screentime app
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Weekend leisure screen-time hours assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Weekend day (screen time for leisure)
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Weekday work/study screen-time hours assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Weekday (screen time for work/study)
|
Baseline, pre-intervention, post-intervention (1 month)
|
|
Weekend work/study screen-time hours assessed by survey
Time Frame: Baseline, pre-intervention, post-intervention (1 month)
|
Weekend day (screen time for work/study)
|
Baseline, pre-intervention, post-intervention (1 month)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Johannes Thrul, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00023832
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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