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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06049888
Other study ID # 1R01MH135467
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 2024
Est. completion date December 2027

Study information

Verified date August 2023
Source Georgetown University
Contact Kostadin Kushlev, PhD
Phone ?(202) 687-3034?
Email kk1199@georgetown.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date December 2027
Est. primary completion date July 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 14 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Georgetown University National Institute of Mental Health (NIMH)

Outcome

Type Measure Description Time frame Safety issue
Other DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Youth Self Report The average score varies between 0 and 4, with higher scores indicating a worse outcome. Baseline, three months, and six months
Other DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Parent Report The average score varies between 0 and 4, with higher scores indicating a worse outcome. Baseline, three months, and six months
Other Upward Social Comparison (EMA) 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?" Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
Other Offline Social Capital: Quantity of In-Person Social Interactions (EMA) 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.
Other Offline Social Capital: Quality of In-Person Social Interactions (EMA) 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?" Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
Other Quantity of Online Social Interactions (Mobile Sensing) Mediator: Quantity of digital social interactions based on the total number of words participants type on their phone keyboards each day. Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
Other Valence of Online Social Interactions (Mobile Sensing) 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. Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
Other Active (vs Passive) Social Media Use (Mobile Sensing) 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.
Other Passive (vs Active) Social Media Use (Mobile Sensing) 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.
Other Time Spent in Specific Social Media Apps (Mobile Sensing) Time participants spend in specific social media apps as assessed unobtrusively by mobile sensing. Daily throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.
Primary Revised Child Anxiety and Depression Scale (RCADS-25): Total Score The average score varies between 0 and 4, with higher scores indicating a worse outcome. Baseline, three months, and six months
Secondary Revised Child Anxiety and Depression Scale (RCADS-25): Depression Subscale The average score varies between 0 and 4, with higher scores indicating a worse outcome. Baseline, three months, and six months
Secondary Revised Child Anxiety and Depression Scale (RCADS-25): Anxiety Subscale The average score varies between 0 and 4, with higher scores indicating a worse outcome. Baseline, three months, and six months
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