Does Social Media Impact Adolescent Mental Health?

• ClinicalTrials.gov Identifier: NCT06049888
• Recruitment Status: Not yet recruiting
• First Posted: September 22, 2023
• Last Update Posted: September 22, 2023
• Sponsor: Georgetown University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Georgetown University

Tracking Information

• First Submitted Date: August 23, 2023
• First Posted Date: September 22, 2023
• Last Update Posted Date: September 22, 2023
• Estimated Study Start Date: August 2024
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 16, 2023)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 16, 2023)

• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: September 16, 2023)

• 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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Does Social Media Impact Adolescent Mental Health?
• Official Title: Causal Effects of Exposure to Social Media on Adolescent Mental Health
• Brief Summary: 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Basic Science
• Condition: Mental Health

Intervention

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.

Study Arms

• No Intervention: Naturalistic Social Media
  In this control condition, participants will have no study-imposed restrictions on social media use.
• Experimental: Restricted Social Media
  Participants will have social media apps on their phones blocked for three months.
  Intervention: Behavioral: Restricted Social Media

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: September 16, 2023): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2027
• Estimated Primary Completion Date: July 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. is an adolescent who is between the ages of 11 and 14;
2. is an adolescent whose parents have decided to buy them their first smartphone;
3. is an adolescent both of whose parents/guardians consent for them to be in the study;
4. 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:

1. is an adolescent who has severe developmental problems (e.g., autism, severe language delay);
2. is an adolescent who is currently or has ever been diagnosed with severe or moderately severe mental illness;
3. is an adolescent who is currently or has ever experienced suicidal ideation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 11 Years to 14 Years (Child)
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Kostadin Kushlev, PhD; ‭(202) 687-3034‬; kk1199@georgetown.edu

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06049888
• Other Study ID Numbers: 1R01MH135467( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: 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.

• Current Responsible Party: Georgetown University
• Original Responsible Party: Same as current
• Current Study Sponsor: Georgetown University
• Original Study Sponsor: Same as current
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Not Provided
• PRS Account: Georgetown University
• Verification Date: August 2023