Psychological DistressNCT07506525
Flourish in Schools Pilot Study
A study testing Flourish in people with Psychological Distress and Suicidal Ideation, run by Candice Biernesser at 2 sites in United States.
Trial summary
This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools. Specifically, the study aims to: 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… Read more about this study
- Who is it for?
- Ages 11 to 21 years
- Conditions the study is for
- Psychological Distress, Suicidal Ideation
- What is being tested?
- Flourish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Mar 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 11-21 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Bay Village School District
Bay Village, Ohio, 44140
Megan Basel, 440-617-7300, megan.basel@bayschoolsohio.org
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15146
Kelly Cassella, Ed.D., 412-373-5235, info@newstoryschools.com
About this study
Official title: Adaptation and Implementation of Flourish Within Schools: Strengthening Suicide Prevention Services for Adolescents Experiencing Online Victimization
This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools.
Specifically, the study aims to:
- 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.
- 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
Read the detailed description
Assessment Visits:
As part of this study, adolescents will participate in four assessment visits at baseline and 2, 4, and 12 weeks following onboarding to the study intervention with the 2-week visit being a brief survey and the other visits involving questionnaires and clinical interviews. Assessments cover a range of topics including mood, anxiety, suicidal thoughts and behaviors, and social media use and experience.
Study Intervention: Flourish Flourish is a text messaging and web-based intervention that will aim to improve adolescents' capacity to cope following cyberbullying and reduce their suicidal risk. The program focuses on key clinical strategies to improve capacity to adaptively cope with cyberbullying: improving capacity to tolerate distress, social problem-solving, and motivation toward help-seeking. The duration of Flourish is 4 weeks. Flourish primarily operates through an automated texting program, which is designed to be self-paced with branching logic, aiming to provide the right type of support at the right time youth need it. A website extends the content available on Flourish and also offers resources related to social media and mental health for teens, parents, and educators. The frequency with which youth interact with Flourish will differ from person to person. However, participants are expected to interact with Flourish approximately 2-3 times per week.
Onboarding to Flourish and Coaching Prior to initiating Flourish, youth will complete a brief text-based survey that will provide information about Flourish, guide youth on how to use it, and provide opportunities to personalize the program toward their interests and goals. During onboarding, students will also identify key social supports, including close friends for distraction outside of a crisis, caregivers and other trusted adults, professional contacts (e.g., therapists or school-based mental health professionals), and crisis hotlines. Subsequently, students will meet with a health coach via a call, who will review the survey, verify crisis contacts, and discuss students' motivations and goals toward using Flourish over the next 4 weeks. The coach will then reconnect with students approximately at the mid-point (2 weeks) and end-point (4 weeks) of their use to discuss progress toward goal attainment and address any motivational or technical barriers toward ongoing engagement.
Collaboration with Schools. Schools will refer students to the study and receive output reports of students' uptake of Flourish. School staff will communicate with students and caregivers about the study and connect with students to increase their motivation to engage with Flourish. At the conclusion of the trial, school staff will participate in interviews/surveys to offer feedback on the feasibility, acceptability, and appropriateness of Flourish's implementation within their school environment.
- Conditions
- Psychological Distress, Suicidal Ideation
- Being tested
- Flourish
- Keywords
- cyberbullying, suicide, adolescents, digital, schools, social media
- Medical subject headings
- Suicidal Ideation, Cyberbullying, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlourishDevice
Flourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Flourish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed upon completion of the 4-week intervention period
Secondary outcomes (7)
Change in psychological distress from baseline to 2 weeks
Psychological distress will be measured by the Kessler 6-item psychological distress scale (K6). Total scale scores range from 0 to 24 with higher values indicating higher levels of distress and lower values indicating lower distress.
Measured: Assessed at the baseline and Week 2 follow-up assessment visits
Change in psychological distress from baseline to 4 weeks
Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.
Measured: Assessed at the Week 4 follow-up assessment visits
Change in psychological distress from baseline to 12 weeks
Psychological distress will be measured by the Kessler 6-item psychological distress scale. Total scale scores range from 0 to 24, higher values indicating higher levels of distress and lower values indicating lower distress.
Measured: Assessed at the Week 12 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 4 weeks
Severity of suicidal ideation and behavior will be measured with the Columbia Suicide Severity Rating Scale (C-SSRS), an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.
Measured: Assessed at baseline and Week 4 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 12 weeks
Severity of suicidal ideation and behavior will be measured with the C-SSRS, an interviewer-rated measure. Presence of suicidal ideation and behavior will be indicated with yes/no response options. Intensity of ideation will be rated on a scale from 1-5 with higher numbers reflecting higher levels of intensity and lower numbers reflecting lower levels of intensity.
Measured: Assessed at baseline and Week 12 follow-up assessment visits
Change in suicidal ideation from baseline to 4 weeks
Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire (SIQ). The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.
Measured: Assessed at the baseline and Week 4 assessment visits
Change in suicidal ideation from baseline to 12 weeks
Self-reported suicidal ideation will be measured with the Suicidal Ideation Questionnaire. The SIQ has a total score of 0 to 90. Higher scores are indicative of frequent suicidal ideation, and lower scores indicative of infrequent ideation.
Measured: Assessed at the baseline and Week 12 Follow-up assessment visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start14 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open trial.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Candice Biernesser
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Pittsburgh Foundation
- Responsible party
- Sponsor-investigator, Candice Biernesser, University of Pittsburgh
- Investigators
- Candice L Biernesser, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506525
- Sponsor's protocol ID
- STUDY25050221
- Other IDs
- P50MH115838
- Status last verified
- Mar 2026
- First submitted
- 11 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data from enrolled participants, the study protocol, statistical analysis plan, and informed consent form 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) Clinical Data Sharing Statement Policy.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of Flourish Within Schools: Strengthening Suicide Prevention Services for Adolescents Experiencing Online Victimization
- ClinicalTrials.gov ID
- NCT07506525
- Acronym / sponsor ID
- STUDY25050221
- Conditions
- Psychological Distress, Suicidal Ideation
- Keywords
- cyberbullying, suicide, adolescents, digital, schools, social media
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Candice BiernesserUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), The Pittsburgh Foundation
- Study start
- 14 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools.
Specifically, the study aims to:
- 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.
- 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
Detailed description
Assessment Visits:
As part of this study, adolescents will participate in four assessment visits at baseline and 2, 4, and 12 weeks following onboarding to the study intervention with the 2-week visit being a brief survey and the other visits involving questionnaires and clinical interviews. Assessments cover a range of topics including mood, anxiety, suicidal thoughts and behaviors, and social media use and experience.
Study Intervention: Flourish Flourish is a text messaging and web-based intervention that will aim to improve adolescents' capacity to cope following cyberbullying and reduce their suicidal risk. The program focuses on key clinical strategies to improve capacity to adaptively cope with cyberbullying: improving capacity to tolerate distress, social problem-solving, and motivation toward help-seeking. The duration of Flourish is 4 weeks. Flourish primarily operates through an automated texting program, which is designed to be self-paced with branching logic, aiming to provide the right type of support at the right time youth need it. A website extends the content available on Flourish and also offers resources related to social media and mental health for teens, parents, and educators. The frequency with which youth interact with Flourish will differ from person to person. However, participants are expected to interact with Flourish approximately 2-3 times per week.
Onboarding to Flourish and Coaching Prior to initiating Flourish, youth will complete a brief text-based survey that will provide information about Flourish, guide youth on how to use it, and provide opportunities to personalize the program toward their interests and goals. During onboarding, students will also identify key social supports, including close friends for distraction outside of a crisis, caregivers and other trusted adults, professional contacts (e.g., therapists or school-based mental health professionals), and crisis hotlines. Subsequently, students will meet with a health coach via a call, who will review the survey, verify crisis contacts, and discuss students' motivations and goals toward using Flourish over the next 4 weeks. The coach will then reconnect with students approximately at the mid-point (2 weeks) and end-point (4 weeks) of their use to discuss progress toward goal attainment and address any motivational or technical barriers toward ongoing engagement.
Collaboration with Schools. Schools will refer students to the study and receive output reports of students' uptake of Flourish. School staff will communicate with students and caregivers about the study and connect with students to increase their motivation to engage with Flourish. At the conclusion of the trial, school staff will participate in interviews/surveys to offer feedback on the feasibility, acceptability, and appropriateness of Flourish's implementation within their school environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open trial.
| Arm | Type | Receives |
|---|---|---|
| Flourish | Experimental | Device: FlourishParticipants 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. |
Who may qualify
- Ages
- 11 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 11-21 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlourishFlourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth. | Device | Flourish |
Primary outcome
Recruitment rates of eligible participants
Time frame: Assessed upon recruitment to the study
Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.
Retention rates of eligible participants
Time frame: Assessed upon completion of the Week 12 study visits
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.
Level of intervention usage
Time frame: Assessed upon completion of the 4-week intervention period
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.
7 secondary outcomes
Change in psychological distress from baseline to 2 weeks
Time frame: Assessed at the baseline and Week 2 follow-up assessment visits
Change in psychological distress from baseline to 4 weeks
Time frame: Assessed at the Week 4 follow-up assessment visits
Change in psychological distress from baseline to 12 weeks
Time frame: Assessed at the Week 12 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 4 weeks
Time frame: Assessed at baseline and Week 4 follow-up assessment visits
Change in severity of suicidal ideation and behavior from baseline to 12 weeks
Time frame: Assessed at baseline and Week 12 follow-up assessment visits
Change in suicidal ideation from baseline to 4 weeks
Time frame: Assessed at the baseline and Week 4 assessment visits
Change in suicidal ideation from baseline to 12 weeks
Time frame: Assessed at the baseline and Week 12 Follow-up assessment visits
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified data from enrolled participants, the study protocol, statistical analysis plan, and informed consent form 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) Clinical Data Sharing Statement Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Candice L Biernesser, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourish in people with Psychological Distress and Suicidal Ideation, run by Candice Biernesser at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Candice L Biernesser, PhD (412-586-9064, lubbertcl@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates of eligible participants (time frame: Assessed upon recruitment to the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.