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| ID | Type | Description | Link |
|---|---|---|---|
| P50MH115838 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
| The Pittsburgh Foundation | OTHER |
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This study will test Flourish, a digital suicide prevention intervention for cyberbullied youth, within schools.
Specifically, the study aims to:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flourish | Device | Flourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at the baseline and Week 2 follow-up assessment visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Candice L Biernesser, PhD | Contact | 412-586-9064 | lubbertcl@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Candice L Biernesser, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Village School District | Recruiting | Bay Village | Ohio | 44140 | United States |
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.
These data will be released following acceptance of the project's main outcomes manuscript.
Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.
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| ID | Term |
|---|---|
| D059020 | Suicidal Ideation |
| D000077224 | Cyberbullying |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D058445 | Bullying |
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This is an open trial.
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| 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. | 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. | 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. | 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. | 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. | 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. | Assessed at the baseline and Week 12 Follow-up assessment visits |
| University of Pittsburgh | Recruiting | Pittsburgh | Pennsylvania | 15146 | United States |
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| D000374 |
| Aggression |
| D000071277 | Harassment, Non-Sexual |
| D012919 | Social Behavior |