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Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents

NCT06002191 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-11

No results posted yet for this study

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.

Conditions

  • Psychological Distress
  • Suicidal Ideation

Interventions

BEHAVIORAL

Flourish

Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.

BEHAVIORAL

Questionnaires of Online Experiences

Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Candice L Biernesser, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2026-03-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06002191 on ClinicalTrials.gov