Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
August 10, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
November 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
ExpectedSeptember 11, 2025
September 1, 2025
2.3 years
August 10, 2023
September 4, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Recruitment rates of eligible participants
Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.
Assessed upon recruitment to the study
Retention rates of eligible participants
Feasibility will be measured through retention rates of eligible participants, using a cut-off score of 80% for desirable retention rates across the 12-week study period.
Assessed upon completion of the Week 12 study visits
Level of intervention usage
Usage of the intervention will be assessed by engagement with the text messaging intervention one or more times during the study period. A cut-off score of 70% of youth using the intervention one or more times will be used as a minimum requirement for acceptable usage.
Assessed upon completion of the 4-week intervention period
Secondary Outcomes (6)
Change in psychological distress from baseline to 4 weeks
Assessed at the baseline and Week 4 follow-up assessment visits
Change in psychological distress from baseline to 12 weeks
Assessed at the Week 12 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 4 weeks
Assessed at baseline and Week 4 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 12 weeks
Assessed at baseline and Week 12 follow-up assessment visits
Change in suicidal ideation from baseline to 4 weeks
Assessed at the baseline and Week 4 assessment visits
- +1 more secondary outcomes
Other Outcomes (6)
Change in distress tolerance from baseline to 4 weeks
Assessed at the baseline and Week 4 assessment visits
Change in distress tolerance from baseline to 12 weeks
Assessed at the baseline and Week 12 assessment visit
Change in motivation for help-seeking from baseline to 4 weeks
Assessed at the baseline and Week 4 assessment visits
- +3 more other outcomes
Study Arms (2)
Flourish + Questionnaires
EXPERIMENTALParticipants will be onboarded to Flourish by a research study clinician, following which they will receive a text messaging program for 4 weeks as well as an accompanying resources website. As part of the text messaging program, participants will receive brief questionnaires evaluating their online experiences once every 3 days.
Questionnaires Alone
ACTIVE COMPARATORParticipants will be onboarded to a text message program that solely will send participants brief questionnaires evaluating their online experiences once every 3 days.
Interventions
Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Candice L Biernesser, PhD
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Psychiatry
Study Record Dates
First Submitted
August 10, 2023
First Posted
August 21, 2023
Study Start
November 21, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
September 11, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- These data will be released following acceptance of the project's main outcomes manuscript.
- Access Criteria
- Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.
De-identified data from enrolled participants may be shared with investigators within and outside of the University of Pittsburgh and University of Pittsburgh Medical Center for the purpose of studying cyberbullying or suicide risk among adolescents. Data sharing will be consistent with International Committee of Medical Journal Editors (ICMJE) requirements.