- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06049888
Does Social Media Impact Adolescent Mental Health?
June 13, 2025 updated by: Georgetown University
Causal Effects of Exposure to Social Media on Adolescent Mental Health
The mental health of adolescents in the United States has seen a steep decline since 2011, roughly coinciding with the increasing popularity of social media and smartphones.
But does social media have a causal impact on the mental health of adolescents or are concerns about the effect of social media on kids a form of public hysteria?
In this study, the investigators will conduct the first field experiment in 11-14-year-olds to examine whether, how, and for whom social media harms mental health.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kostadin Kushlev, PhD
- Phone Number: 804-585-4385
- Email: kk1199@georgetown.edu
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20057
- Recruiting
- Georgetown University
-
Contact:
- Kostadin Kushlev, PhD
- Email: kk1199@georgetown.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- is an adolescent who is between the ages of 10 and 14;
- is an adolescent whose parents have decided to buy them their first smartphone;
- is an adolescent both of whose parents/guardians consent for them to be in the study;
- is an adolescent who assents to be in the study; 5) is an adolescent who speaks and reads English sufficiently to complete surveys and provide informed consent.
Exclusion Criteria:
- is an adolescent who has severe developmental problems (e.g., autism, severe language delay);
- is an adolescent who is currently or has ever been diagnosed with severe or moderately severe mental illness;
- is an adolescent who is currently or has ever experienced suicidal ideation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Naturalistic Social Media
In this control condition, participants will have no study-imposed restrictions on social media use.
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|
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Experimental: Restricted Social Media
Participants will have social media apps on their phones blocked for three months.
|
Participants (N = 500) will be randomly assigned to either have no study-imposed restrictions on social media use (naturalistic social media condition) or have no access to social media apps on their phones (restricted social media condition).
This manipulation will last three months, after which both groups will have no study-imposed restrictions on social media for three more months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Child Anxiety and Depression Scale (RCADS-25): Total Score
Time Frame: Baseline, three months, and six months
|
The average score varies between 0 and 4, with higher scores indicating a worse outcome.
|
Baseline, three months, and six months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Revised Child Anxiety and Depression Scale (RCADS-25): Depression Subscale
Time Frame: Baseline, three months, and six months
|
The average score varies between 0 and 4, with higher scores indicating a worse outcome.
|
Baseline, three months, and six months
|
|
Revised Child Anxiety and Depression Scale (RCADS-25): Anxiety Subscale
Time Frame: Baseline, three months, and six months
|
The average score varies between 0 and 4, with higher scores indicating a worse outcome.
|
Baseline, three months, and six months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Youth Self Report
Time Frame: Baseline, three months, and six months
|
The average score varies between 0 and 4, with higher scores indicating a worse outcome.
|
Baseline, three months, and six months
|
|
DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Parent Report
Time Frame: Baseline, three months, and six months
|
The average score varies between 0 and 4, with higher scores indicating a worse outcome.
|
Baseline, three months, and six months
|
|
Upward Social Comparison (EMA)
Time Frame: Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
Mediator measured with a single, face-valid item in EMA surveys: "Over the past 24 hours, how often have you compared yourself to someone who you believe is better off than you?"
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Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Offline Social Capital: Quantity of In-Person Social Interactions (EMA)
Time Frame: Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Mediator measured with a single, face-valid item in EMA surveys: "Over past 24 hours, how much time did you spend socializing in person?"
|
Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
|
Offline Social Capital: Quality of In-Person Social Interactions (EMA)
Time Frame: Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
Mediator measured with a single, face-valid item in EMA surveys: "Over past 24 hours, how much did you enjoy your in-person social interactions with others?"
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Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Quantity of Online Social Interactions (Mobile Sensing)
Time Frame: Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Mediator: Quantity of digital social interactions based on the total number of words participants type on their phone keyboards each day.
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Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Valence of Online Social Interactions (Mobile Sensing)
Time Frame: Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
Mediator: Quality/valence of digital social interactions by measuring the balance between positive and negative words participants type on their phone keyboards.
The valence of the words typed will first be scored using the Linguistic Inquiry and Word Count (LIWC) software.
The sum of the valence scores of all words will produce the final score for analysis.
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Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Active (vs Passive) Social Media Use (Mobile Sensing)
Time Frame: Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
Active usage includes creating content and direct messaging, while passive usage includes browsing, scrolling, or watching videos.
Using data from the Inertial Measurement Unit (i.e., accelerometer and gyroscope data) and keyboard input (i.e.
typing or not), an Extremely Randomized Trees algorithm will classify behaviors into active or passive.
|
Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
|
Passive (vs Active) Social Media Use (Mobile Sensing)
Time Frame: Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
Active usage includes creating content and direct messaging, while passive usage includes browsing, scrolling, or watching videos.
Using data from the Inertial Measurement Unit (i.e., accelerometer and gyroscope data) and keyboard input (i.e.
typing or not), an Extremely Randomized Trees algorithm will classify behaviors into active or passive.
|
Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
|
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Time Spent in Specific Social Media Apps (Mobile Sensing)
Time Frame: Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Time participants spend in specific social media apps as assessed unobtrusively by mobile sensing.
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Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 29, 2024
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
February 1, 2028
Study Registration Dates
First Submitted
August 23, 2023
First Submitted That Met QC Criteria
September 16, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 17, 2025
Last Update Submitted That Met QC Criteria
June 13, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1R01MH135467 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Demographic, clinical (self-reports and parent reports), neurocognitive (gradCPT), and passive mobile sensing data (accelerometer, GPS, keyboard input, app usage) will be collected and made available on NIMH Data Archive (NDA).
All data will be de-identified prior to deposition to NDA.
To request access to the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant.
All code for the analyses-including statistical analysis, data transformations, and data cleaning-will be shared on the Open Science Framework (OSF).
The code can be found by searching for "Kostadin Kushlev" on the Open Science Framework.
IPD Sharing Time Frame
All data will be deposited to NDA starting 12 months after the award begins and will be deposited every six months thereafter following the usual NDA data submission dates.
IPD Sharing Access Criteria
To request access to the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant.
The standard NDA data access process allows access for one year and is renewable.
The protocol and code will be available on OSF to anybody with access to the internet.
De-identified data associated with each publication will also be made available on OSF by the publication date of each paper.
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
No
Studies a U.S. FDA-regulated device product
No
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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