100 Participants Needed

Social Threat for Suicidal Ideation

(STARS Trial)

AP
KM
Overseen ByKiera M James, Ph.D.
Age: < 18
Sex: Female
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how teenage girls’ attention to social situations affects their emotional health and risk for suicidal thoughts and behaviors (STBs). By studying their reactions to social threats, specifically perceived negative social interactions, researchers hope to learn why some teens develop STBs while others do not. This insight could help improve emotional health and reduce teen suicides. Girls aged 12-17 who have experienced suicidal thoughts, behaviors, or self-injury in the past year and own an iPhone might be a good fit for this study. Participants will complete interviews, computer tasks, and daily smartphone surveys over six months.

As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially preventing teen suicides.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for adolescents?

Research has shown that activities like those in this study are generally easy for participants to handle. This trial does not use medication or involve medical procedures, reducing the risk of physical side effects. The main activities include interviews, computer tasks, and surveys on smartphones. These methods are safe and typically cause no harm.

The study aims to understand how teens' reactions to social situations relate to their emotional health. The activities collect information rather than alter or treat participants' behavior. Previous research indicates that these assessments are safe for participants. Overall, the study minimizes risks and focuses on observing natural reactions to social situations.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adolescents with suicidal thoughts and behaviors respond to social threats using an EEG task. Unlike typical treatments that primarily involve medication or therapy, this method focuses on understanding brain activity in response to social stressors. This could unveil new insights into the neurological patterns associated with suicidal ideation, potentially leading to more effective, personalized interventions for young people.

What evidence suggests that this study's methods could be effective for understanding suicidal thoughts and behaviors in teens?

Research has shown that understanding social challenges is crucial in addressing suicidal thoughts and behaviors in teens. Studies have found that teens' responses to social situations can impact their sense of belonging and mental health. For instance, certain social experiences can increase the risk of self-harm, which links to suicidal thoughts. Addressing these reactions may help reduce the risk of suicidal thoughts and improve emotional well-being. While researchers continue to explore direct treatments, understanding these social dynamics is a key step in developing effective solutions.16789

Who Is on the Research Team?

KM

Kiera M James, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This study is for girls aged 12-17 at high risk for suicidal thoughts and behaviors. They must be willing to undergo clinical assessments, brain signal recordings during computer tasks, daily smartphone surveys for a month, and share their text messages from that period. The trial excludes those who don't meet the age or risk criteria.

Inclusion Criteria

I am healthy with no serious brain function issues that affect my thinking or daily tasks.
Willing and able to give informed assent
I own an iPhone.
See 3 more

Exclusion Criteria

Lifetime presence of a DSM-5 Autistic Spectrum Disorder
Current DSM-5 Psychotic Disorder or severe Substance Use Disorder
Presence of head injury or congenital neurological anomalies (based on parent report)
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (virtual)

Baseline Assessment

Participants complete a clinical interview and questionnaires to assess eligibility and baseline measures

1 day
1 visit (virtual or in-person)

Laboratory Assessment

Participants complete the ERP Decoding Working Memory task while EEG is recorded

1 day
1 visit (in-person)

Ecological Momentary Assessment

Participants complete smartphone surveys three times a day for 30 days to assess social experiences and STBs

4 weeks
90 surveys (remote)

Follow-up

Participants complete online follow-up questionnaires assessing STBs at 3 and 6 months

6 months
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Social threat

Trial Overview

The study aims to understand how attention to social information affects adolescents' relationships and emotional health. It tests whether these factors influence feelings of social connectedness and the risk of developing suicidal thoughts and behaviors over six months.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Adolescents (12-17) with past year STBs and/or NSSI.Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Citations

Suicidal Ideation - StatPearls - NCBI Bookshelf - NIH

Although risk factors for suicide are well-established, the same level of certainty does not extend to suicidal ideation. A 2017 meta-analysis ...

The effectiveness of the TaySH (Transitional Age Youth ...

The primary outcome was the reduction of NSSI, and the secondary outcomes were suicide risk, emotional dysregulation, the psychopathological clinical ...

Efficacy of interventions for suicide and self-injury in ...

Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of ...

Nonsuicidal Self-Injury Among Individuals Seeking Treatment

Nonsuicidal self-injury thoughts and diminished self-efficacy uniquely signaled risk for self-injury. Clinically, these results advocate for ...

Non‐Suicidal Self‐Injury in Adolescents: A Systematic ...

The findings from this study offer guidance to enhance nursing competencies in the early identification, risk assessment, and therapeutic ...

Suicidal ideation, non-suicidal self-injury and ...

Anxiety symptoms and life stress were associated with increased risk of recent suicide ideation in students with low experiential avoidance, compared to those ...

The Relationships Between Nonsuicidal Self-Injury ...

For every 1-point increase from mean family connectedness, the odds of screening positive for suicide risk decreased by 62% (odds ratio 0.38, 95 ...

Adverse clinical outcomes among youths with nonsuicidal self ...

Risk estimates are hazard ratios (HRs) with 95% confidence intervals (CIs). a Adjusted for sex. b Adjusted for sex and number of clinical ...

Psychosocial dynamics of suicidality and nonsuicidal self- ...

Concerningly, self-harm is the most important risk factor for death by suicide. Better understanding of self-harm is not only a moral imperative ...