Does Social Media Impact Adolescent Mental Health?
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ClinicalTrials.gov Identifier: NCT06049888 |
Recruitment Status :
Not yet recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
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Condition or disease | Intervention/treatment | Phase |
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Mental Health | Behavioral: Restricted Social Media | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 500 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Causal Effects of Exposure to Social Media on Adolescent Mental Health |
Estimated Study Start Date : | August 2024 |
Estimated Primary Completion Date : | July 2027 |
Estimated Study Completion Date : | December 2027 |
Arm | Intervention/treatment |
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No Intervention: Naturalistic Social Media
In this control condition, participants will have no study-imposed restrictions on social media use.
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Experimental: Restricted Social Media
Participants will have social media apps on their phones blocked for three months.
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Behavioral: Restricted Social Media
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. |
- 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.
- 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.
- 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.
- 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.
- 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.
- 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?"
- 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. ]Mediator measured with a single, face-valid item in EMA surveys: "Over past 24 hours, how much time did you spend socializing in person?"
- 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?"
- 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. ]Mediator: Quantity of digital social interactions based on the total number of words participants type on their phone keyboards each day.
- 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.
- 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.
- 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.
- 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. ]Time participants spend in specific social media apps as assessed unobtrusively by mobile sensing.
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Ages Eligible for Study: | 11 Years to 14 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- is an adolescent who is between the ages of 11 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06049888
Contact: Kostadin Kushlev, PhD | (202) 687-3034 | kk1199@georgetown.edu |
Responsible Party: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT06049888 |
Other Study ID Numbers: |
1R01MH135467 ( U.S. NIH Grant/Contract ) |
First Posted: | September 22, 2023 Key Record Dates |
Last Update Posted: | September 22, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Analytic Code |
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. |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
social media mental health depression anxiety |