- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506525
Flourish in Schools Pilot Study
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Candice L Biernesser, PhD
- Phone Number: 412-586-9064
- Email: lubbertcl@upmc.edu
Study Locations
-
-
Ohio
-
Bay Village, Ohio, United States, 44140
- Recruiting
- Bay Village School District
-
Contact:
- Megan Basel
- Phone Number: 440-617-7300
- Email: megan.basel@bayschoolsohio.org
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15146
- Recruiting
- University of Pittsburgh
-
Contact:
- Kelly Cassella, Ed.D.
- Phone Number: 412-373-5235
- Email: info@newstoryschools.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Flourish
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.
|
Flourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Assessed upon recruitment to the study
|
|
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.
|
Assessed upon completion of the Week 12 study visits
|
|
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.
|
Assessed upon completion of the 4-week intervention period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in psychological distress from baseline to 12 weeks
Time Frame: Assessed at the Week 12 follow-up assessment visits
|
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
Time Frame: Assessed at baseline and Week 4 follow-up assessment visits
|
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
Time Frame: Assessed at baseline and Week 12 follow-up assessment visits
|
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
Time Frame: Assessed at the baseline and Week 4 assessment visits
|
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
Time Frame: Assessed at the baseline and Week 12 Follow-up assessment visits
|
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
|
|
Change in psychological distress from baseline to 2 weeks
Time Frame: Assessed at the baseline and Week 2 follow-up assessment visits
|
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
|
|
Change in psychological distress from baseline to 4 weeks
Time Frame: Assessed at the Week 4 follow-up assessment visits
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Candice L Biernesser, PhD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY25050221
- P50MH115838 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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