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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Georgetown University

Tracking Information
First Submitted Date  ICMJE August 23, 2023
First Posted Date  ICMJE September 22, 2023
Last Update Posted Date September 22, 2023
Estimated Study Start Date  ICMJE August 2024
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE 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  ICMJE Does Social Media Impact Adolescent Mental Health?
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Mental Health
Intervention  ICMJE 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 16, 2023)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date July 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kostadin Kushlev, PhD ‭(202) 687-3034‬ kk1199@georgetown.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06049888
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Georgetown University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE Not Provided
PRS Account Georgetown University
Verification Date August 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP