Flourish in Schools Pilot Study

NCT07506525 | Recruiting FDA Device

• 2 other identifiers: STUDY25050221P50MH115838
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools. Specifically, the study aims to:

1. 1.Examine if Flourish is effective and can be feasibly delivered within schools among middle and high school students who are experiencing cyberbullying and suicide risk factors. Feasibility will be evidenced by recruitment and retention rates to the study (\> or = 80%) and use of Flourish at least weekly among 80% of youth. Effectiveness will be evidenced by students reporting improvements in psychological distress and suicidal thoughts over the 3-month follow-up period.
2. 2.Understand barriers or facilitators to Flourish's adoption within schools. We will conduct exit interviews and brief surveys with school personnel to inform optimal strategies for implementing Flourish within schools

Conditions

Psychological Distress; Suicidal Ideation

Keywords

cyberbullying; suicide; adolescents; digital; schools; social media

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 Flourish at least weekly, on average, during the study period. A cut-off score of 70% of youth using the intervention at least weekly will be used as a minimum requirement for acceptable usage.

  Assessed upon completion of the 4-week intervention period

Secondary Outcomes (7)

• Change in psychological distress from baseline to 2 weeks

  Assessed at the baseline and Week 2 follow-up assessment visits

• Change in psychological distress from baseline to 4 weeks

  Assessed at the 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

Study Arms (1)

Flourish

EXPERIMENTAL

Participants will complete an onboarding process, after which they will receive Flourish, a text and web-based program for 4 weeks, accompanied by three brief sessions with a health coach.

Device: Flourish

Interventions

Flourish DEVICE

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

Flourish

Eligibility Criteria

• Age: 11 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• English-speaking
• have access to a cell phone or tablet that can send/receive SMS text messages
• identified as a student who could benefit from the program by a school staff member - OR - screened eligible based on experiencing cyberbullying and suicide risk factors in the past 3 months
• past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization Scale and/or presence of online discrimination as measured by a modified measure from the Adolescent Brain and Cognitive Development (ABCD study)
• past 3-month history of suicide risk factors, assessed by: 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:

• if a student has a condition that might inhibit their ability to effectively engage with Flourish (e.g., intellectual challenges or low literacy levels)
• if a students' level of acuity would suggest a higher level of care or referral to emergency services
• if a school staff judges the intervention is not appropriate for the student

Sponsors & Collaborators

• Candice Biernesser: lead
• National Institute of Mental Health (NIMH): collaborator
• The Pittsburgh Foundation: collaborator

Study Sites (2)

Bay Village School District

Bay Village, Ohio, 44140, United States

RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, 15146, United States

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Cyberbullying; Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Bullying; Aggression; Harassment, Non-Sexual; Social Behavior

Study Officials

• Candice L Biernesser, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Candice L Biernesser, PhD

CONTACT

412-586-9064; lubbertcl@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry

Model Details: This is an open trial.

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: April 1, 2026
• Study Start: March 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

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.

Locations

US (2)