NCT07344142

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

January 7, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

5 months

First QC Date

January 7, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weekday leisure screen-time hours assessed by survey

    Weekday (screen time for leisure)

    Baseline, pre-intervention, post-intervention (1 month)

Secondary Outcomes (14)

  • 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)

  • +9 more secondary outcomes

Study Arms (2)

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

Behavioral: Digital Wellbeing UnitBehavioral: Online Teacher Training

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.

Behavioral: Digital Wellbeing UnitBehavioral: Parent WhatsApp GroupsBehavioral: Online Teacher Training

Interventions

(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.

Enhanced treatmentTreatment as usual

(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.

Enhanced treatment

(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.

Enhanced treatmentTreatment as usual

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sulaiman Al Rahji University

Buraidah, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Internet Addiction Disorder

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Johannes Thrul

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Thrul

CONTACT

Nazmus Saquib

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2026

First Posted

January 15, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Data will be shared upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Supporting information will be shared upon reasonable request.
Access Criteria
Supporting information will be shared upon reasonable request.

Locations