- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07531290
PeerScreen Trial - Reducing Screen Media Use in Peer-groups of Young People
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
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jesper Schmidt-Persson, PhD
- Phone Number: +4565502054
- Email: jespedersen@health.sdu.dk
Study Contact Backup
- Name: Anne K Gejl, PhD
- Phone Number: +4565507908
- Email: akgejl@health.sdu.dk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Screen media reduction
Peer groups randomized to the intervention will undergo a four-week screen media reduction.
|
Participants will reduce their recreational screen media use across devices. For smartphone use, participants will be asked to reduce their use to a maximum of 1 hour/day. Because social media use will not be permitted on computers or tablets during the intervention, this limit will also encompass participants' social media use. Research staff will help each participant set up smartphone app limits for the ten most used social media and gaming applications, add a widget to their home screen showing the current amount of time they have spent on their phone, and turn off non-essential notifications. For television, computer and tablet use, participants will reduce their use to 14 hours/week (with no specific daily limit), but social media use is not allowed on these devices. We will recommend participants to particularly reduce their solitary screen media use. Participants will be asked to keep their devices outside the bedroom, and they will be provided with a free alarm clock. |
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mental wellbeing on the Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS)
Time Frame: 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.
|
From baseline (day 1) to post-intervention (day 42).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in total weekly duration of face-to-face social interaction with peer-group members measured by Bluetooth Low Energy (BLE) beacon proximity events
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
Face-to-face social interaction with peer-group members will be assessed as the total duration of proximity events, expressed in minutes per week, using Bluetooth Low Energy (BLE) beacon data collected via the SDU Connect application.
The application logs the frequency and duration of proximity events between participants within a predefined distance threshold.
The outcome measure is the change in weekly minutes of peer-group proximity from the 14-day baseline period before randomization to the final 21 days of the intervention period.
|
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
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
Face-to-face social interactions with individuals outside the participant's household and peer group will be assessed using daily self-report collected via the SDU Connect application.
These interactions include, for example, family members not living in the household, other friends, and other relations.
The outcome measure is the change in the average weekly frequency of self-reported face-to-face social interactions from the 14-day baseline period before randomization to the final 21 days of the intervention period.
|
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
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
Total sleep time will be assessed using continuous monitoring with the Garmin Venu 4 wearable device.
Total sleep time will be derived using the device's sleep algorithm and expressed as average minutes of sleep per night.
The outcome measure is the change in average nightly total sleep time from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
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
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
Physical activity will be assessed using continuous monitoring with the Garmin Venu 4 wearable device.
Physical activity will be expressed as average number of steps per day derived from the device.
The outcome measure is the change in average daily step count from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in average nocturnal heart rate variability measured by Garmin Venu 4 (root mean square of successive differences)
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
Heart rate variability during sleep will be assessed using continuous monitoring with the Garmin Venu 4 wearable device.
Heart rate variability will be expressed as the root mean square of successive differences (RMSSD) in milliseconds (ms), derived from the device during sleep periods.
The outcome measure is the change in average nocturnal RMSSD from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
|
Change in average nightly Garmin Sleep Score measured by Garmin Venu 4
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
Sleep quality will be assessed using the Garmin Sleep Score (proprietary overall sleep score) derived from continuous monitoring with the Garmin Venu 4 wearable device.
Garmin Sleep Score is a device-derived composite sleep measure ranging from 0 to 100 points, with higher scores indicating better sleep quality.
The outcome measure is the change in average nightly Garmin Sleep Score from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period
|
|
Change in average daily minutes of moderate-to-vigorous physical activity measured by Garmin Venu 4
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
Physical activity intensity will be assessed using continuous monitoring with the Garmin Venu 4 wearable device.
Moderate-to-vigorous physical activity will be expressed as average minutes per day spent participating in moderate-to-vigorous intensity physical activity, derived from the device.
The outcome measure is the change in average daily minutes of moderate-to-vigorous physical activity from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
|
Change in dyadic physiological synchrony in heart rate during peer co-presence measured by Bluetooth Low Energy (BLE) beacons and Garmin Venu 4
Time Frame: From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
Physiological synchrony will be assessed as similarity in heart rate time series between dyads of peer-group members during periods of co-presence identified by Bluetooth Low Energy (BLE) beacon data.
Heart rate will be measured continuously using Garmin Venu 4 wearable devices.
Synchrony will be quantified using a Time Warp Edit Distance (TWED)-based dissimilarity measure applied to dyadic heart rate time series during beacon-defined co-presence periods, with lower dissimilarity indicating greater physiological synchrony.
The outcome measure is the change in average dyadic heart rate synchrony from the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
From the 14-day baseline period before randomization to the final 21 days of the 4-week intervention period.
|
|
Change in self-reported perceived stress score measured by the 4-item Cohen Perceived Stress Scale (PSS-4)
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Perceived stress will be assessed using the 4-item Cohen Perceived Stress Scale (PSS-4).
The PSS-4 total score will be used, with higher scores indicating greater perceived stress.
Outcome data will be collected at baseline, post-intervention, and long-term follow-up.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported social connectedness score measured by the Friendship Scale
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Social connectedness will be assessed using the Friendship Scale.
The outcome measure is the total Friendship Scale score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater social connectedness.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported loneliness score measured by the UCLA 3-Item Loneliness Scale
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Loneliness will be assessed using the UCLA 3-Item Loneliness Scale.
The outcome measure is the total UCLA 3-Item Loneliness Scale score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater loneliness.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported life satisfaction score measured by Cantril's Ladder
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Life satisfaction will be assessed using Cantril's Ladder.
The outcome measure is the self-reported Cantril's Ladder score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater life satisfaction.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported depressive symptoms score measured by the Mood and Feelings Questionnaire Short Form (MFQ-SF)
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Depressive symptoms will be assessed using the Mood and Feelings Questionnaire Short Form (MFQ-SF).
The outcome measure is the total MFQ-SF score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater depressive symptom severity.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported anxiety symptoms score measured by the Generalized Anxiety Disorder 2-Item scale (GAD-2)
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder 2-Item scale (GAD-2).
The outcome measure is the total GAD-2 score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater anxiety symptom severity.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported sleep disturbance score measured by the PROMIS Pediatric Sleep Disturbance Short Form 8a
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Sleep disturbance will be assessed using the PROMIS Pediatric Sleep Disturbance Short Form 8a.
The outcome measure is the total PROMIS Pediatric Sleep Disturbance Short Form 8a score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater sleep disturbance.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in self-reported problematic smartphone use score measured by the Smartphone Addiction Scale-Short Version (SAS-SV)
Time Frame: Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
Problematic smartphone use will be assessed using the Smartphone Addiction Scale-Short Version (SAS-SV).
The outcome measure is the total SAS-SV score at baseline (Day 1), post-intervention (Day 42), and long-term follow-up (Day 70).
Higher scores indicate greater problematic smartphone use.
|
Baseline (day 1), post-intervention (day 42), and long-term follow-up (day 70)
|
|
Change in daily self-reported mood score measured by a visual analogue scale (VAS)
Time Frame: Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
Mood will be assessed using a self-reported visual analogue scale (VAS) administered daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
The outcome measure is the change in daily mood scores from the 14-day baseline period before randomization to the final 21 days of the intervention period, with higher scores indicating more positive mood.
|
Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
|
Change in daily self-reported stress score measured by a visual analogue scale (VAS)
Time Frame: Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
Stress will be assessed using a self-reported visual analogue scale (VAS) administered daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
The outcome measure is the change in daily stress scores from the 14-day baseline period before randomization to the final 21 days of the intervention period, with higher scores indicating greater perceived stress.
|
Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
|
Change in daily self-reported sleepiness score measured by a visual analogue scale (VAS)
Time Frame: Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
Sleepiness will be assessed using a self-reported visual analogue scale (VAS) administered daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
The outcome measure is the change in daily sleepiness scores from the 14-day baseline period before randomization to the final 21 days of the intervention period, with higher scores indicating greater sleepiness.
|
Daily during the 14-day baseline period before randomization and daily during the 42-day intervention period.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anders Grøntved, PhD, University of Southern Denmark
Study record dates
Study Major Dates
Study Start (Estimated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S-20250078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- 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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