Social Threat, Adolescent Relationships, and Suicidality Study
STARS
Neurocognitive Responses to Social Threat: Links to Day-to-day Connectedness and Suicidality in Adolescent Girls
2 other identifiers
interventional
100
1 country
1
Brief Summary
In recent years, adolescents are having higher rates of emotional health problems, such as suicidal thoughts and behaviors (STBs). The goal of this study is to learn about how teens' attention to different types of information relates to their real-world relationships and their emotional health. The investigators hope this study will help understand why some teens go on to have suicidal thoughts and behaviors and other teens do not. This information will help investigators learn how to improve emotional health in teens and reduce teen suicides. Participants will be 100 female adolescents (ages 12-17) at high risk for STBs who will complete a series of assessments over the course of 6 months. Assessments include a baseline clinical interview, a visit to examine neural responses during a computer tasks, daily smartphone surveys about social experiences and social connectedness, and follow up questionnaires assessing STBs. Participants will also be asked to donate their text messages during the month that they complete smartphone surveys. The research procedures will help investigators learn how adolescents react to different types of social situations. Investigators want to see if these reactions affect:
- Complete a 10-15 minute screening call to determine eligibility for the study
- Complete one 3 hour virtual (or in-person) interview consisting of a clinical assessment and questionnaires.
- Complete a 2.5-hour in person visit to complete computer tasks while record brain signals are recorded
- Complete \~5 minute smartphone surveys three times a day for 30 days, asking about their daily social experiences and their mood and feelings.
- Provide investigators with retrospective access to their text/direct messages from the month the participant was completing the smartphone surveys.
- Complete online follow-up questionnaires at 3 and 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2025
CompletedFirst Posted
Study publicly available on registry
December 19, 2025
CompletedStudy Start
First participant enrolled
January 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 30, 2030
February 12, 2026
December 1, 2025
4.4 years
December 17, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Day-to-day social connectedness
Participants will be asked to rate their social connectedness with their parents/caregivers and peers 3x a day for 30 days using a 0 (not connected) to 100 (very connected) point scale.
1 month
Suicidal thoughts and behaviors
Participants' suicidal thoughts and behaviors will be assessed will be assessed using the Self-Injurious Thoughts and Behaviors Interview (SITBI) and Suicidal Ideation Questionnaire-Jr (SIQ-JR). Severity of suicidal thoughts and behaviors will be operationalized as (0) absent, (1) passive SI, (2) active SI, (3) SI with a method, (4) SI with some intent, but no specific plan, (5) SI with specific plan and intent, and (6) suicide attempt(s).
1, 2, 3, and 4 weeks after the intervention as well as three and six months later
Study Arms (1)
Adolescents (12-17) with past year STBs and/or NSSI.
EXPERIMENTALAdolescent aged 12-17 with a past year suicidal thoughts and behaviors (STBs) and/or non-suicidal self-injury will complete an EEG task that measures their response to social threat.
Interventions
EEG Visit: Participants will be presented with pictures of female actors with emotional expressions. They will be asked to remember the identities of actors displaying happy, sad, angry, and neutral expressions and tested on their memory. This task examines participants' internal attention to facial cues of emotion while asking them to remember the identities of actors displaying emotional expressions. EMA Over 30 days, participants will be asked to be report on their social experiences and suicidal thoughts and behaviors three times a day.
Eligibility Criteria
You may qualify if:
- Between ages 12-17
- Reported recurrent suicidal thoughts and behaviors and/or non-suicidal self-injury within the past year.
- Medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment that would interfere with task performance
- Assigned female at birth
- Willing and able to give informed assent
- Own an iPhone
You may not qualify if:
- Unable to read or speak English or cognitive impairment preventing ability to complete assessments
- Lifetime presence of a neurological or serious medical condition
- Lifetime presence of a DSM-5 Autistic Spectrum Disorder
- Current DSM-5 Psychotic Disorder or severe Substance Use Disorder
- Uncorrected visual disturbance (\<20/40 Snellen visual acuity)
- Presence of head injury or congenital neurological anomalies (based on parent report).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kiera M James, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Professor
Study Record Dates
First Submitted
December 17, 2025
First Posted
December 19, 2025
Study Start
January 19, 2026
Primary Completion (Estimated)
June 30, 2030
Study Completion (Estimated)
August 30, 2030
Last Updated
February 12, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- 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.
All individual participant data collected during the study, after deidentification, may be shared.