Recruiting

ImHere4U

Sponsor:

University of Pittsburgh

Code:

NCT06002191

Conditions

Psychological Distress

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Flourish

Questionnaires of Online Experiences

Study Details

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.

Conditions

Psychological Distress

Suicidal Ideation

Study ID

NCT06002191

Start date

Nov 21, 2023

Status verified date

Jul, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May 7, 2026

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Flourish + Questionnaires

Participants 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.

active comparator: Questionnaires Alone

Participants 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

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

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.

Primary outcome measure

  • Recruitment rates of eligible participants [ Time Frame: Assessed upon recruitment to the study ]
  • Retention rates of eligible participants [ Time Frame: Assessed upon completion of the Week 12 study visits ]
  • Level of intervention usage [ Time Frame: Assessed upon completion of the 4-week intervention period ]

Central Contacts and Locations

Central contacts

Candice L Biernesser, PhD

412-586-9064lubbertcl@upmc.edu

Locations

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Candice Biernesser, PhD

412-586-9064lubbertcl@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-06.