Digital Intervention for Suicide Prevention in Cyberbullied Adolescents

Overseen By Candice L Biernesser, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Intellectual challenges, low literacy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital tool called Flourish, designed to assist young people who have experienced cyberbullying and are at risk for suicide. The researchers aim to determine if Flourish can enhance problem-solving skills, manage distress, and reduce suicidal thoughts more effectively than completing questionnaires alone. English-speaking teens who have been cyberbullied in the last three months and have felt suicidal may qualify for this study. Participants will either use the Flourish tool alongside questionnaires or only complete questionnaires to compare outcomes. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could shape future support tools for cyberbullying victims.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It is best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that the Flourish digital intervention is safe for cyberbullied adolescents?

Research shows that Flourish, a digital tool for preventing suicide, is safe and well-liked. Studies with similar groups, such as LGBTQ+ youth who have experienced online bullying, have found Flourish to be helpful. Participants used it without major issues, indicating it is generally well-tolerated.

Although large-scale studies specifically on Flourish's safety are lacking, it is being tested with individuals who often face mental health challenges. Early results suggest it might aid in problem-solving and reducing distress, indicating a positive safety profile, as past research has reported no serious problems.

Since the trial is in its early stages, researchers aim to understand how Flourish works and how people respond to it, rather than proving its safety and effectiveness on a large scale. So far, Flourish appears to be a safe option for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Flourish digital intervention for suicide prevention in cyberbullied adolescents because it offers a unique approach by combining digital support with regular feedback on online experiences. Unlike traditional methods that may rely on therapy sessions or medications, Flourish provides continuous support through a text messaging program, which is easily accessible and can be integrated into the daily lives of adolescents. Additionally, the intervention includes a resources website, offering participants further tools and information to help manage their experiences. This innovative approach could offer timely support and empower adolescents to navigate cyberbullying more effectively.

What evidence suggests that this digital intervention is effective for suicide prevention in cyberbullied adolescents?

Research shows that Flourish, a digital tool formerly known as imHere4U, aims to reduce suicidal thoughts in teenagers bullied online. In this trial, some participants will use Flourish along with completing questionnaires. Studies have found that digital tools like Flourish can enhance problem-solving and stress management skills, crucial for addressing emotional issues. Early results suggest that users of similar digital tools feel more motivated and less stressed. The program also offers feedback on online interactions, which participants have found helpful and easy to use. Although still under study, these factors suggest that Flourish could effectively support at-risk youth. ^{4 6 7 8 9}

Who Is on the Research Team?

Candice L Biernesser, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 12-17 who have experienced cyberbullying and are at risk of suicide, evidenced by distress or suicidal thoughts. They must be able to text and not require a higher level of care like hospitalization.

Inclusion Criteria

English-speaking

Past 3-month history of suicidal risk, including psychological distress (>13 on the 6-item Kessler Psychological Distress Scale) and/or suicidal ideation or behavior (via the Columbia Suicide Severity Rating Scale)

Access to a phone or device capable of text messaging

Exclusion Criteria

Intellectual challenges, low literacy levels, or other conditions that might inhibit adolescents' ability to effectively engage with Flourish (reported by parents and, if needed, confirmed through the age-appropriate Wechsler Intelligence scale)

I need hospital care or emergency services due to my condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Onboarding

Adolescents and their caregivers participate in a session to onboard to Flourish, including orientation and personalization of the intervention

30 minutes

1 visit (in-person)

Intervention

Participants receive the Flourish intervention or Questionnaires Alone for 4 weeks, with interactions approximately 2-3 times per week

4 weeks

Follow-up

Participants are monitored for changes in suicidal ideation, psychological distress, and other outcomes

24 weeks

3 visits (in-person) at 4, 12, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Flourish
• Questionnaires

Trial Overview The study tests 'Flourish,' a digital intervention aimed at preventing suicide among cyberbullied youth, comparing it with just answering questionnaires. It also explores the use of machine learning feedback on social media interactions.

How Is the Trial Designed?

Group I: Flourish + Questionnaires Experimental Treatment 2 Interventions

Participants will be onboarded to Flourish by a research study clinician, following which they will receive a text messaging program for 4 weeks as well as an accompanying resources website. As part of the text messaging program, participants will receive brief questionnaires evaluating their online experiences once every 3 days.

Group II: Questionnaires Alone Active Control 1 Intervention

Participants will be onboarded to a text message program that solely will send participants brief questionnaires evaluating their online experiences once every 3 days.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 19,406 European children aged 11-16, it was found that cybervictims and cyberbully-victims were more likely to view suicide-related web content compared to those not involved in cyberbullying, highlighting a potential risk factor for these groups.

All roles in cyberbullying, especially cyberbully-victims, showed increased viewing of self-harm content and higher rates of emotional, peer, and conduct problems, suggesting that targeted interventions could help address the specific needs of each group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adolescents' Viewing of Suicide-Related Web Content and Psychological Problems: Differentiating the Roles of Cyberbullying Involvement. Görzig, A.[2022]

Cyberbullying significantly increases the risk of suicidal and self-harm behaviors in children and adolescents, with various risk factors identified, such as mental health issues, substance abuse, and specific conditions like Autism Spectrum Disorder.

Protective factors, including strong school connections, parental support, and personal skills, can mitigate the negative effects of cyberbullying, suggesting that interventions focused on these areas may help reduce suicide risk in affected youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of risk and protective factors for suicidal and self-harm behaviors among children and adolescents involved with cyberbullying. Dorol-Beauroy-Eustache, O., Mishara, BL.[2021]

A systematic review of 30 studies on cyberbullying interventions found that school-based programs are effective in reducing both perpetration and victimization, highlighting the importance of context in intervention delivery.

The review identified a need for longer follow-up periods to assess the lasting impact of these interventions and called for more research on the effectiveness of programs delivered in home settings and through digital platforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dosage, Context, and Modality of Interventions to Prevent Cyberbullying Perpetration and Victimization: a Systematic Review. Doty, JL., Girón, K., Mehari, KR., et al.[2022]

In a study of 1,037 adolescents, negative bystander responses to cyberbullying were linked to worse mental health outcomes for victims, highlighting the importance of bystander behavior in the context of cyberbullying.

The research suggests that current prevention programs should focus not only on encouraging positive bystander actions but also on reducing negative responses, as positive behaviors did not significantly impact victims' mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Bystander Reactions to Cyberbullying and Victims' Emotional Experiences and Mental Health. DeSmet, A., De Bourdeaudhuij, I., Walrave, M., et al.[2019]

The IRCB program, an online self-guided cognitive behavioral therapy intervention, significantly improved adolescents' likelihood of using coping skills like self-compassion and challenging negative thoughts related to cyberbullying, based on a pilot study with 54 participants.

Participants also showed increased help-seeking attitudes towards counseling services, indicating that the program may effectively encourage adolescents to seek support when facing cyberbullying, although it did not significantly boost their confidence in coping abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of an Online Psychoeducational Program on Cyberbullying That Aims to Increase Confidence and Help-Seeking Behaviors Among Adolescents. Chillemi, K., Abbott, JM., Austin, DW., et al.[2020]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06002191/development-and-testing-of-imhere4u-a-digital-suicide-prevention-intervention-for-cyberbullied-adolescents

Development and Testing of ImHere4U: a Digital Suicide ... The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital ...

2. reporter.nih.gov reporter.nih.gov/search/14EACD094D84C7D77598B8961CAA4A01A2FFCEB861BF/project-details/10904924

Development and Testing of imHere4U: A Digital Suicide Prevention ... A complementary research plan will focus on development and testing of imHere4U, a just-in- time, suicide prevention intervention for cyberbullied adolescents.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2214782923000635

A digital suicide prevention intervention for LGBTQ+ youth ... Next steps will include testing the feasibility and efficacy of Flourish through controlled trials and examining effectiveness and implementation outcomes ...

4. afsp.org afsp.org/story/research-roundup-june-2024

Research Roundup June 2024: Recently Published ... The Research Roundup is a regular update of recently published findings in suicide prevention research.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT06002191?keyword=%22Suicidal%20Ideation%22

San Mateo Clinical Trial Development and Testing of imHere4U ~H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and ...

6. reporter.nih.gov reporter.nih.gov/project-details/11167769

Project Details - NIH RePORTER Suicide is the second leading cause of death among adolescents, and youth who are cyberbullied are twice as likely to exhibit suicidal thoughts and ...

7. researchgate.net researchgate.net/publication/373536987_Development_and_codesign_of_flourish_A_digital_suicide_prevention_intervention_for_LGBTQ_youth_who_have_experienced_online_victimization

A digital suicide prevention intervention for LGBTQ+ youth ... To address these gaps, this study aims to develop Flourish, a digital suicide prevention intervention for LGBTQ+ youth who have experienced OV.

8. withpower.com withpower.com/trial/phase-suicide-9-2023-66517

Digital Intervention for Suicide Prevention in Cyberbullied ... H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced ...

9. starcenter.pitt.edu starcenter.pitt.edu/sites/default/files/workshop_2023_biernesser.pdf

Social Media and Adolescent Suicide Draws upon criteria for cyberbullying: Willful and repeated harm inflicted through the use of computers, cell phones, and other electronic ...