Flourish in Schools Pilot Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flourish.
- Who it may be relevant to
- Registry conditions: Psychological Distress, Suicidal Ideation. Basic parameters: 11 years — 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Adaptation and Implementation of Flourish Within Schools: Strengthening Suicide Prevention Services for Adolescents Experiencing Online Victimization
Overview
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 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. 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.
Interventions
- Device Flourish
Flourish is a text messaging and web-based program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
Primary outcome measures
- Recruitment rates of eligible participants [Time frame: Assessed upon recruitment to the study]
- Retention rates of eligible participants [Time frame: Assessed upon completion of the Week 12 study visits]
- Level of intervention usage [Time frame: Assessed upon completion of the 4-week intervention period]
Secondary outcome measures (7)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- Bay Village School District — Bay Village
- University of Pittsburgh — Pittsburgh
Identifiers
NCT: NCT07506525 · STUDY25050221 · P50MH115838