NCT06049888

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Sep 2024Feb 2028

First Submitted

Initial submission to the registry

August 23, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

September 29, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 17, 2025

Status Verified

June 1, 2025

Enrollment Period

3.1 years

First QC Date

August 23, 2023

Last Update Submit

June 13, 2025

Conditions

Keywords

social mediamental healthdepressionanxiety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Revised Child Anxiety and Depression Scale (RCADS-25): Depression Subscale

    Baseline, three months, and six months

  • Revised Child Anxiety and Depression Scale (RCADS-25): Anxiety Subscale

    Baseline, three months, and six months

Other Outcomes (10)

  • DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Youth Self Report

    Baseline, three months, and six months

  • DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure Parent Report

    Baseline, three months, and six months

  • Upward Social Comparison (EMA)

    Every three days throughout the study with two averages computed for 0 to 3 months and 3 to 6 months.

  • +7 more other outcomes

Study Arms (2)

Naturalistic Social Media

NO INTERVENTION

In this control condition, participants will have no study-imposed restrictions on social media use.

Restricted Social Media

EXPERIMENTAL

Participants will have social media apps on their phones blocked for three months.

Behavioral: Restricted Social Media

Interventions

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.

Restricted Social Media

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgetown University

Washington D.C., District of Columbia, 20057, United States

RECRUITING

MeSH Terms

Conditions

Psychological Well-BeingDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorBehavioral SymptomsMental Disorders

Central Study Contacts

Kostadin Kushlev, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2023

First Posted

September 22, 2023

Study Start

September 29, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

June 17, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.

Locations