Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000110381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
14/11/2025
Date registered
Help: Date registered
28/01/2026
Date last updated
Help: Date last updated
28/01/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/01/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Behavior change interventions for Social Networking Sites addiction in school-going adolescents of Karachi, Pakistan
Scientific title
Perceptions and targeted behavioral change interventions for social networking site addiction in school-going adolescents of Karachi: A concurrent embedded mixed-methods case study
Additional trial identifiers [1] 315942 0
Nil known
Universal Trial Number (UTN)
U1111-1331-3481
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Social networking sites addiction 339735 0
Problematic Social Media Use 340212 0
Condition category
Condition code
Public Health 335989 335989 0 0
Health promotion/education
Mental Health 335990 335990 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Interventions will be designed and categorized based on the insights received earlier. They were extracted through the conducted Focus Group Discussions (FGDs) (from all age groups and class levels ) & In-Depth Interviews (IDIs) from all stakeholders. FGDs were conducted by trained researchers in Qualitative studies, from school-going adolescents, one each from each grade with a total of 36 participants. Additionally, 2 more FGDs were conducted with 6 participants each, who were the parents of the school-going adolescents. Furthermore, 2 IDIs were done with school heads for their relevant insights.
Interventions will be designed specifically for this study and will then be pilot-tested to assess cultural appropriateness. Furthermore, a psychologist who will be a part of the research team (co-supervisor) will check them for language, accuracy and for use among different age groups of adolescents. They will be conducted in the form of weekly vlogs shared with adolescents in the intervention arm. There will be 02 to 05 minutes duration videos shared every weekend (on Saturdays & Sundays) with a WhatsApp number provided at the end to reach out in case of any further queries. These vlogs will be shared by sharing their link through Dropbox (video storage platform) over a period of four weeks based on different issues like SNS problematic usage and its effect on mental health, sleep, academic performance, etc. Students will be reminded to watch the videos two days prior to uploading of videos. Throughout the week, crisp and smart reinforcement messages will be sent to them via their email/WhatsApp to recognize the importance of moderated use of SNS. The taking of screenshots of the vlogs will be encouraged as daily reminders for adolescents. Participants will be given a checklist to fill at the end of watching video, which will be shared over WhatsApp to ensure adherence. That checklist will be handed over to the PI at the end of the intervention period.
Intervention code [1] 332554 0
Behaviour
Description of the comparator or control
Control group continues with their routine practice and receive screenshot of pictorial messages (as standard of care)
Control group
Active

Outcomes
Primary outcome [1] 343518 0
Change in the addiction pattern/over-usage of social networking sites(social media)- this will be assessed as a composite outcome
Timepoint [1] 343518 0
baseline, post intervention and 3 months post intervention
Secondary outcome [1] 454682 0
Readiness to change the use of social media
Timepoint [1] 454682 0
baseline, post intervention and 3 months follow-up

Eligibility
Key inclusion criteria
Age between 11-16 years
Either male or female (or any other gender)
User of any of the listed social media (Facebook, Instagram, WhatsApp, YouTube, Snapchat, Tumblr, TikTok or Discord) for the past one year
In possession of a functioning laptop/smartphone for attending online intervention vlogs and receiving text messages
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Any student undergoing psychiatric or psychological treatment/ counseling
Any student taking anti-psychotics or any treatment for chronic disorders (diabetes, cancer, kidney disease, asthma)
Any student suffering from chronic mental illness, e.g. depression, anxiety, schizophrenia, etc.
Any student who has suffered a major trauma in the past year, e.g. death of a loved one, accident, etc.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Normality tests will be done for quantitative data. Comparison of pre and post assessment will be done through paired t-test for normally distributed data and Wilcoxon signed rank for skewed data in both study arms. Multiple linear regression model will be used for reporting predictors of SNS addiction with their ß-coefficients and their corresponding 95% confidence intervals. Additionally, we will also conduct simple and multiple linear regression analyses to examine unadjusted and adjusted associations between various baseline and socio-demographic variables and readiness to change the adolescents’ SNS usage between baseline and 3 month follow-up. Statistical significance will be taken at p-value <0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2025
Date of last participant enrolment
Anticipated
Actual
8/09/2025
Date of last data collection
Anticipated
Actual
20/01/2026
Sample size
Target
260
Accrual to date
Final
260
Recruitment outside Australia
Country [1] 27605 0
Pakistan
State/province [1] 27605 0
Sindh

Funding & Sponsors
Funding source category [1] 320552 0
University
Name [1] 320552 0
Vice Chancellor Seed Funding Initiative from Dow University of Health Sciences (DUHS), Karachi, Pakistan
Country [1] 320552 0
Pakistan
Primary sponsor type
University
Name
Dow University of Health Sciences
Address
Country
Pakistan
Secondary sponsor category [1] 323165 0
None
Name [1] 323165 0
Address [1] 323165 0
Country [1] 323165 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319092 0
Institutional Review Board
Ethics committee address [1] 319092 0
Ethics committee country [1] 319092 0
Pakistan
Date submitted for ethics approval [1] 319092 0
22/10/2024
Approval date [1] 319092 0
09/01/2025
Ethics approval number [1] 319092 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 146230 0
Dr Zaeema Ahmer
Address 146230 0
School of Public Health, Dow University of Health Sciences, University Road. Near SUPARCO Chowk, Gulzar E Hijri Scheme 33, Karachi, 74200
Country 146230 0
Pakistan
Phone 146230 0
+923009225371
Fax 146230 0
Email 146230 0
[email protected]
Contact person for public queries
Name 146231 0
Zaeema Ahmer
Address 146231 0
School of Public Health, Dow University of Health Sciences, University Road. Near SUPARCO Chowk, Gulzar E Hijri Scheme 33, Karachi, 74200
Country 146231 0
Pakistan
Phone 146231 0
+923009225371
Fax 146231 0
Email 146231 0
[email protected]
Contact person for scientific queries
Name 146232 0
Zaeema Ahmer
Address 146232 0
School of Public Health, Dow University of Health Sciences, University Road. Near SUPARCO Chowk, Gulzar E Hijri Scheme 33, Karachi, 74200
Country 146232 0
Pakistan
Phone 146232 0
+923009225371
Fax 146232 0
Email 146232 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Institutional policies on data sharing



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    IRB-3760.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.