Suicidal Thoughts and BehaviorsSTARSNCT07294079
Social Threat, Adolescent Relationships, and Suicidality Study
A study testing Social threat in people with Suicidal Thoughts and Behaviors and Social Connectedness, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years, women only
- Conditions the study is for
- Suicidal Thoughts and Behaviors, Social Connectedness, Responses to Social Threat
- What is being tested?
- Social threat
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to 30 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Kiera M James, Ph.D., 412-624-8992, kij9@pitt.edu
Amber Pereira, M.A., 412-353-9329, amp702@pitt.edu
About this study
Official title: Neurocognitive Responses to Social Threat: Links to Day-to-day Connectedness and Suicidality in Adolescent Girls
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.
Read more
The research procedures will help investigators learn how adolescents react to different types of social situations. Investigators want to see if these reactions affect:
- How connected adolescents feel to others in their daily lives
- 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.
- Complete online follow-up questionnaires at 3 and 6 months
Read the detailed description
There is no assignment to conditions. All participants will receive the same intervention, which is the completion of an experimental task in which participants are asked to remember the identities of actors displaying happy, sad, angry, and neutral expressions and tested on their memory. The study is designed to evaluate the effect of sustained neurocognitive responsivity to social threat on the participants' social connectedness and suicidality.
This study includes 1) a baseline clinical interview, 2) a laboratory-based EEG assessment (which includes the experimental task described above), 3) smartphone surveys in conjunction with passive ambulatory assessment, and 4) 3- and 6-month follow-up assessments of STBs.
Specifically, after phone screening, female adolescents (n=100, ages 12-17) will complete diagnostic interviews and symptom measures to confirm eligibility. Adolescents' current and lifetime STBs, including the presence, frequency, severity, and age-of-onset of suicidal ideation, plans, behaviors, and attempts will be assessed and differentiated from non-suicidal self-injurious thoughts and behaviors using the Self-Injurious Thoughts and Behaviors Interview.
Eligible participants will be invited for a laboratory visit during which they will complete the ERP Decoding Working Memory task while EEG is recorded. During each trial of the task, a face (angry, sad, happy, neutral) is randomly presented in the center of the screen. Participants are asked to remember the identity of the actor and will be tested on their memory of the identity after a delay. Specifically, participants will be asked to identify the actor from a group of four actors displaying the same emotion.
Following the laboratory visit, adolescents will complete 30-days of smartphone surveys (i.e., ecological momentary assessments [EMA]; 3 samples/day) assessing social experiences, social connectedness, and STBs. Following standard procedures, they will be randomly sampled within three blocks of time (morning, after school, evening) for a total of 90 surveys. Youth can "snooze" each prompt for up to one hour. The after-school prompt allows youth to report on experiences and thoughts they had during the school day. Once a week during the 30-day EMA protocol, participants will complete questions assessing STBs currently and during the previous week, using items adapted for EMA from the Columbia-Suicide Severity Rating Scale. During these weekly assessments, participants will indicate any STBs in the last week (i.e., since the last assessment). Finally, participants' time-stamped text, iMessage, and WhatsApp messaging logs will be downloaded at the end of the 30-day period using the software, iMazing, which creates an encrypted backup of these data.
Finally, STB assessments will be repeated at the 3- and 6-month follow-up assessments.
Certain information is withheld to protect the scientific integrity of the study design.
- Being tested
- Social threat
- Keywords
- Suicide Ideation, Social Threat, EEG, Adolescent, Teen
- Medical subject headings
- Suicidal Ideation, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social threatBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents (12-17) with past year STBs and/or NSSI. | Experimental | Adolescent 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. Receives: Behavioral: Social threat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 1, 2, 3, and 4 weeks after the intervention as well as three and six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start19 Jan 2026
- Primary completion30 Jun 2030 (estimated)
- Study completion30 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal Thoughts and BehaviorsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be similar (12-17 with a past year suicidal thoughts and behaviors and/or non-suicidal self-injury) and will experience the same procedures.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Kiera James, University of Pittsburgh
- Investigators
- Kiera M James, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294079
- Sponsor's protocol ID
- STUDY25050182
- Other IDs
- K23MH141548
- Acronym
- STARS
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual participant data collected during the study, after deidentification, may be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Responses to Social Threat: Links to Day-to-day Connectedness and Suicidality in Adolescent Girls
- ClinicalTrials.gov ID
- NCT07294079
- Acronym / sponsor ID
- STARS / STUDY25050182
- Keywords
- Suicide Ideation, Social Threat, EEG, Adolescent, Teen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 30 Jun 2030 (estimated)
- Study completion
- 30 Aug 2030 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How connected adolescents feel to others in their daily lives
- 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.
- Complete online follow-up questionnaires at 3 and 6 months
Detailed description
There is no assignment to conditions. All participants will receive the same intervention, which is the completion of an experimental task in which participants are asked to remember the identities of actors displaying happy, sad, angry, and neutral expressions and tested on their memory. The study is designed to evaluate the effect of sustained neurocognitive responsivity to social threat on the participants' social connectedness and suicidality.
This study includes 1) a baseline clinical interview, 2) a laboratory-based EEG assessment (which includes the experimental task described above), 3) smartphone surveys in conjunction with passive ambulatory assessment, and 4) 3- and 6-month follow-up assessments of STBs.
Specifically, after phone screening, female adolescents (n=100, ages 12-17) will complete diagnostic interviews and symptom measures to confirm eligibility. Adolescents' current and lifetime STBs, including the presence, frequency, severity, and age-of-onset of suicidal ideation, plans, behaviors, and attempts will be assessed and differentiated from non-suicidal self-injurious thoughts and behaviors using the Self-Injurious Thoughts and Behaviors Interview.
Eligible participants will be invited for a laboratory visit during which they will complete the ERP Decoding Working Memory task while EEG is recorded. During each trial of the task, a face (angry, sad, happy, neutral) is randomly presented in the center of the screen. Participants are asked to remember the identity of the actor and will be tested on their memory of the identity after a delay. Specifically, participants will be asked to identify the actor from a group of four actors displaying the same emotion.
Following the laboratory visit, adolescents will complete 30-days of smartphone surveys (i.e., ecological momentary assessments [EMA]; 3 samples/day) assessing social experiences, social connectedness, and STBs. Following standard procedures, they will be randomly sampled within three blocks of time (morning, after school, evening) for a total of 90 surveys. Youth can "snooze" each prompt for up to one hour. The after-school prompt allows youth to report on experiences and thoughts they had during the school day. Once a week during the 30-day EMA protocol, participants will complete questions assessing STBs currently and during the previous week, using items adapted for EMA from the Columbia-Suicide Severity Rating Scale. During these weekly assessments, participants will indicate any STBs in the last week (i.e., since the last assessment). Finally, participants' time-stamped text, iMessage, and WhatsApp messaging logs will be downloaded at the end of the 30-day period using the software, iMazing, which creates an encrypted backup of these data.
Finally, STB assessments will be repeated at the 3- and 6-month follow-up assessments.
Certain information is withheld to protect the scientific integrity of the study design.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be similar (12-17 with a past year suicidal thoughts and behaviors and/or non-suicidal self-injury) and will experience the same procedures.
| Arm | Type | Receives |
|---|---|---|
| Adolescents (12-17) with past year STBs and/or NSSI. | Experimental | Behavioral: Social threatAdolescent 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social threatEEG 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. | Behavioural | Adolescents (12-17) with past year STBs and/or NSSI. |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. All individual participant data collected during the study, after deidentification, may be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiera M James, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social threat in people with Suicidal Thoughts and Behaviors and Social Connectedness, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiera M James, Ph.D. (412-634-0004, kij9@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Day-to-day social connectedness (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.