What this study is
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.
What's being tested
- Flourish
Intervention · BEHAVIORAL
Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
- Questionnaires of Online Experiences
Intervention · BEHAVIORAL
Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.
Study details
- Sponsor
- University of Pittsburgh
- Conditions
- Psychological Distress · Suicidal Ideation
- Enrolling
- 80 people
- Starts
- 2023-11-21
- Est. completion
- 2027-08
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 12 Years – 17 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
- Candice Biernesser, PhD · Contact412-586-9064lubbertcl@upmc.edu
Recruiting
Study team
Sponsor
University of Pittsburgh
Study ID STUDY22070044
Principal investigator
Candice L Biernesser, PhD
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.