- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06574932
The Effect of Multi-Strategy Approaches on Limiting Digital Exposure
Screen Time and Sanity: The Impact of Multi-Strategy Approaches on Limiting Digital Exposure to Enhance Adolescent Mental Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent research highlights the growing concern over the impact of digital overuse on students' mental well-being. The constant barrage of notifications, the pressure to stay connected, and the addictive nature of social media can create a state of perpetual stress and distraction. This, in turn, can hinder students' ability to focus, engage in meaningful social interactions, and maintain a healthy balance between their academic and personal lives.
A multi-assignment program offers a promising intervention to counteract these negative effects. By encouraging students to disconnect from digital devices and reduce their online engagement temporarily, a digital detox can provide the opportunity to reset their relationship with technology. This period of disconnection allows students to regain control over their time, reduce stress, and foster healthier habits that support their mental well-being.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MUHAMMAD Rashaad
- Phone Number: 03337474991
- Email: stunning003@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants must be enrolled as students at any of the three universities of Lahore.
- Participants should be 18 to 25 years old, as this demographic is typically more engaged in smartphone usage and may experience varying mental health effects.
- Participants must own and regularly use a smartphone. Regular use is a smartphone for at least two hours per day.
- Participants must be willing to provide written informed consent, acknowledging their understanding of the study and agreeing to participate voluntarily.
- Participants must be able to read and understand the language in which the questionnaires and assessments are administered (likely English or Urdu, depending on the study design).
- Only full-time students will be included to ensure that their daily routines and stress levels are more comparable across the study group.
Exclusion Criteria:
- Individuals who have been diagnosed with severe psychiatric disorders (such as schizophrenia, bipolar disorder, or other major psychiatric conditions) will be excluded. These conditions could introduce confounding variables that may affect the study's results.
- Individuals who are currently undergoing treatment for severe mental health conditions or are taking medication that could significantly impact mental health and smartphone usage will be excluded to avoid confounding effects.
- Individuals who have recently experienced major life events (such as the death of a close family member, major accidents, or other significant trauma) within the last six months may be excluded, as these events could influence mental health independently of smartphone use.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
The experimental group will be engaged in multi-strategy approaches including screen time and sanity challenges, weekly screen-free days, screen time reduction goals, screen time tracking, structured daily routines, parental involvement, and monitoring, family media plans, alternative engagements, and promotion of offline social interactions.
|
The experimental group will be engaged in multi-strategy approaches including screen time and sanity challenges, weekly screen-free days, screen time reduction goals, screen time tracking, structured daily routines, parental involvement, and monitoring, family media plans, alternative engagements, and promotion of offline social interactions.
|
|
No Intervention: Control
The control group will be given no intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Generalized anxiety
Time Frame: 6-months from baseline
|
Generalized anxiety change will be measured by (GAD-7).
seven-item instrument that is used to measure or assess the severity of generalized anxiety disorder (GAD).
The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions.
GAD-7 total score for the seven items ranges from 0 to 21.Score 0-4: Minimal Anxiety.
Score 5-9: Mild Anxiety.
Score 10-14: Moderate Anxiety.
Score greater than 15: Severe Anxiety.
|
6-months from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression
Time Frame: 6-months from baseline
|
Depression change will be measured by PHQ-9.
PHQ-9 scores can be used to plan and monitor treatment.
To score the instrument, tally the numbers of all the checked responses under each heading (not at all=0, several days=1, more than half the days=2, and nearly every day=3).
Add the numbers together to total the score on the bottom of the questionnaire.
PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms
|
6-months from baseline
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: MUHAMMAD ARSHED, PhD, University of Lahore
Publications and helpful links
General Publications
- Mojtabai R, Olfson M, Han B. National Trends in the Prevalence and Treatment of Depression in Adolescents and Young Adults. Pediatrics. 2016 Dec;138(6):e20161878. doi: 10.1542/peds.2016-1878. Epub 2016 Nov 14.
- Shakya HB, Christakis NA. Association of Facebook Use With Compromised Well-Being: A Longitudinal Study. Am J Epidemiol. 2017 Feb 1;185(3):203-211. doi: 10.1093/aje/kww189.
- Basen I. You can't stop checking your phone because Silicon Valley designed it that way. CBC Radio 2018 Sept 14. Available: www.cbc.ca/radio/thesundayedition/the-sunday-edition-september-16-2018-1.4822353/you-can-t-stop-checking-your-phone-because-silicon-valley-designed-it-that-way-1.4822360
- NHS Digital. Mental Health of Children and Young People in England, 2017: Summary of key findings. NHS Digital; 2018 [cited 2019 Sep 21]. Available from: https://files.digital.nhs.uk/A6/EA7D58/MHCYP%202017%20Summary.pdf
- Patalay P, Gage SH. Changes in millennial adolescent mental health and health-related behaviours over 10 years: a population cohort comparison study. Int J Epidemiol. 2019 Oct 1;48(5):1650-1664. doi: 10.1093/ije/dyz006.
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
Other Study ID Numbers
- FAHSS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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