NCT06817993

Brief Summary

There has been much interest in the potential role of social media (SM) use in driving a current mental health crisis among teens, with a dire need for evidence that goes beyond self-report. One important avenue is to understand the role of the brain in driving the effects of SM use on emotional health and vice versa. However, there is almost no research addressing these questions, largely due to a lack of tasks that can probe the neural correlates of modern SM use. The goal of this clinical trial is to develop and validate a new developmentally-appropriate and ecologically-valid functional magnetic resonance imaging (fMRI) and eyetracking task, the TeenBrainOnline (TBO) Task, that is more realistic and similar to modern SM platforms. Participants will be 50 teens (ages 13-17) with depressive symptoms who will complete the final version of TBO task during fMRI with eye-tracking, an older Chatroom Interact (CHAT-I) Task, daily surveys of SM use, and measures of depressive symptoms. Our goal is to show that the task works by:

  • Demonstrating that it activates expected regions of the brain and visual attention biases toward feedback cues.
  • Showing that brain and eyetracking (visual attention) activity on the task explain variability in depressive symptoms at baseline and three months later, and work better than similar indices from an older task.
  • Showing that brain and eyetracking (visual attention) activity on the task are associated with real-world measures of social media use collected during daily surveys. Specifically, The investigators expect that teens whose brain and eyetracking activity suggests they are more sensitive to feedback on SM will report a social evaluation orientation toward social media use in daily life, such as engaging a lot in social comparison, worrying about missing out, and caring about getting a lot of likes and comments. Participants will be asked to:
  • complete a 10-15 minute screening call to determine eligibility for the study
  • complete one 90 minute virtual study visit to complete questionnaires and prepare for the MRI visit (visit 1)
  • submit 24 photos to our study specific social media site
  • complete an (in person) MRI scan visit (\~4 hours), which consists of 2 tasks where they will interact with peers (visit 2)
  • complete \~5 minute smartphone surveys 3 times a day for 16 days, asking about their daily experiences online and emotional reactions.
  • complete 2 online questionnaires asynchronously 3 months after their scan date

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
11mo left

Started Mar 2025

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 Progress58%
Mar 2025Mar 2027

First Submitted

Initial submission to the registry

December 20, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 21, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2027

Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

December 20, 2024

Last Update Submit

May 4, 2026

Conditions

Keywords

DepressionAdolescentTeenSocial MediaSocial AcceptanceSocial RejectionfMRINeuroimaging

Outcome Measures

Primary Outcomes (1)

  • Average Affective Salience Network Activation to Social Reward and Threat stimuli

    The investigators will measure neural activity (as measured by fMRI response) in regions within the Affective Salience network (ASN) in response to social threat and reward in the TBO and CHAT-I tasks. Average activation will be compared in each region between experiences of social reward, social threat, and neutral experiences as well as baseline.

    During the MRI Scan/intervention (occurring once ~4 weeks into the study)

Secondary Outcomes (3)

  • Depressive Symptoms Score as Assessed by the MFQ-C

    baseline (phone screen), immediately before the Intervention, 3 months

  • Average Visual Fixation time to Social Reward and Threat stimuli

    During the MRI Scan/intervention (occurring once~4 weeks into the study)

  • Reported Emotional Experiences of Threat and Reward during Daily Social Media Use

    3 times a day for 16 days

Study Arms (1)

Adolescents aged 13-17 with at least mild symptoms of depression

EXPERIMENTAL

Adolescents in Phase 2 will be screened for depressive symptoms using the MFQ-c. 20 teens will have MFQ-c scores within the mild range (MFQ = 12-25). The sample will be stratified, with 30 teens who will have moderate to severe depressive symptoms as assessed by the MFQ-C. (MFQ ≥25; N=30)

Behavioral: Rejection and Acceptance Feedback

Interventions

Participants will be administered cues of peer acceptance and rejection from virtual peers during an fMRI task. In the CHAT-I task, they will be chosen or not chosen to discuss various topics with a virtual peer. In the TBO Task, they will receive a high or low number of likes relative to the other photos displayed of peers. They will also view comments on their posts from peers, which may have positive, negative, or neutral content.

Adolescents aged 13-17 with at least mild symptoms of depression

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Between ages 13-17
  • Depression screening scores on the MFQ-C in the mild (MFQ = 12-25; N = 20) or moderate-to-severe range (MFQ ≥25; N=30)
  • Possess their own smartphone to complete web-based ecological momentary assessments (EMA) using WebDataExpress.
  • use social media apps (e.g. Instagram, twitter, reddit, discord, YouTube, etc.) at least 3 times a week, on average, per teen report

You may not qualify if:

  • Presence of a serious neurological or medical condition, by parent report
  • Unable to read or speak English or cognitive impairment preventing ability to complete assessments.
  • Hearing impairment preventing ability to hear and understand instructions conveyed via headphones in the MRI scanner
  • Possible pregnancy, as determined by participant report
  • Presence of probable substance use disorder, as determined by participant report
  • Presence of MRI contraindications (e.g., dental braces, history of metallic foreign objects in body such as aneurysm clips or other devices or questionable history of metallic fragments, claustrophobia, or a weight of above 300 lbs)
  • Taking medications that affect the central nervous system other than antidepressants (stable dose allowed due to high rates of use among teens with depressive symptoms) or stimulants if required 36 hours before the scan.
  • Completion of Chatroom Interact Task or TBO Task in prior studies
  • Screening positive on the Autism Spectrum Screening Questionnaire, or screening positive on the Youth Inventory-4/ for a potential psychotic disorder or substance use disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

DepressionSocial Isolation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Jennifer S Silk, Ph.D

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Helmet T Karim, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer S Silk, Ph.D

CONTACT

Sarah E Nelson, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: All participants will be similar (13-17 with at least mild depression symptoms) and will experience the same procedures.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 20, 2024

First Posted

February 10, 2025

Study Start

March 21, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

March 30, 2027

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

All individual participant data collected during the study, after deidentification, may be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Scientific data will be made accessible no later than 1 year after the grant end date. Any subject level data and associated analyzed data will be shared at time of publication. No end date.
Access Criteria
Deidentified data will be submitted to and made available on the National Institute of Mental Health Data Archive (NDA). To obtain data access, researchers will follow the established procedures within NDA, and the NDA Data Access Committee will determine the approvals for these requests. Access will be given for any legitimate scientific purpose, as determined by NDA Access Committee.

Locations