NCT07294079 · University of Pittsburgh
Social Threat, Adolescent Relationships, and Suicidality Study
(STARS)
What this study is about
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.
View original scientific description
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: 1. How connected adolescents feel to others in their daily lives 2. Adolescents' longer-term risk for suicidal thoughts and behaviors (STBs) Participants will be asked to: * 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.
Interventions
BEHAVIORAL
Social threat
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.
Primary outcome measures
Day-to-day social connectedness
Time frame: 1 month
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.
Suicidal thoughts and behaviors
Time frame: 1, 2, 3, and 4 weeks after the intervention as well as three and six months later
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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).
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 12, 2026 · Source of record for eligibility and locations