NCT06002191 Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents
| NCT ID | NCT06002191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pittsburgh |
| Condition | Psychological Distress |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-11-21 |
| Primary Completion | 2026-05-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-11-21 with a primary completion date of 2026-05-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents. The specific aims are to: Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, \>35% underserved youth). H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates \> 80% and imHere4U engagement \> 70%. H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period. Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and \>70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) \> 6.
Eligibility Criteria
Inclusion Criteria: * English-speaking * access to a phone or device capable of text messaging * past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization and Perpetration Scale and/or presence of online discrimination measured by a modified version of a discrimination measured developed as part of the Adolescent Brain and Cognitive Development (ABCD) study * past 3-month history of suicidal risk, including: psychological distress (\>13 on the 6-item Kessler Psychological Distress Scale) and/or suicidal ideation or behavior (via the Columbia Suicide Severity Rating Scale) Exclusion Criteria: * intellectual challenges, low literacy levels, or other conditions that might inhibit adolescents' ability to effectively engage with Flourish (reported by parents and, if needed, confirmed through the age-appropriate Wechsler Intelligence scale) * acuity levels suggesting need for a higher level of care (e.g., inpatient hospitalization) or referral for emergency services
Contact & Investigator
Candice L Biernesser, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh
Frequently Asked Questions
Who can join the NCT06002191 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 17 Years, studying Psychological Distress. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06002191 currently recruiting?
Yes, NCT06002191 is actively recruiting participants. Contact the research team at lubbertcl@upmc.edu for enrollment information.
Where is the NCT06002191 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT06002191 clinical trial?
NCT06002191 is sponsored by University of Pittsburgh. The principal investigator is Candice L Biernesser, PhD at University of Pittsburgh. The trial plans to enroll 80 participants.