NCT07294079

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

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
52mo left

Started Jan 2026

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Progress6%
Jan 2026Aug 2030

First Submitted

Initial submission to the registry

December 17, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2030

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2030

Last Updated

February 12, 2026

Status Verified

December 1, 2025

Enrollment Period

4.4 years

First QC Date

December 17, 2025

Last Update Submit

February 9, 2026

Conditions

Keywords

Suicide IdeationSocial ThreatEEGAdolescentTeen

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.

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.

Behavioral: Social threat

Interventions

Social threatBEHAVIORAL

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.

Adolescents (12-17) with past year STBs and/or NSSI.

Eligibility Criteria

Age12 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

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

RECRUITING

MeSH Terms

Conditions

Suicidal IdeationBehavior

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral Symptoms

Study Officials

  • Kiera M James, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kiera M James, Ph.D.

CONTACT

Amber Pereira, M.A.

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 (12-17 with a past year suicidal thoughts and behaviors and/or non-suicidal self-injury) and will experience the same procedures.
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

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