Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents

Suicidal Ideation Clinical Trial

Official title: Development and Testing of imHere4U: A Digital Suicide Prevention Intervention for Cyberbullied Adolescents

Status Recruiting

Clinical Trial Summary

The objective of this study is to test the feasibility and preliminary efficacy of Flourish (formerly referred to as imHere4U), a digital suicide prevention intervention for cyberbullied adolescents.

The specific aims are to:

Aim #1: Conduct a randomized controlled trial (RCT) comparing Flourish+Questionnaires vs. Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 (N=80, >35% underserved youth).

H2a. Primary outcome: Feasibility will be evidenced by recruitment/retention rates > 80% and imHere4U engagement > 70%.

H2b. Secondary outcomes: Youth assigned to Flourish+Questionnaires will report improved problem-solving capacity, distress tolerance, and motivation and reduced distress and suicidal ideation than youth assigned to Questionnaires Alone over the 6-month follow-up period.

Exploratory Aim: Examine the feasibility of delivering feedback on online interactions from machine learning algorithms. All youth assigned to Flourish may optionally provide their social media data to receive feedback from machine learning algorithms. H3a. Feedback from algorithms will have high acceptability (identified via qualitative themes and >70% acceptance rates) and usability, defined by mean scores on Post-Study System and Usability Questionnaire (PSSUQ) > 6.

Clinical Trial Description

Assessment Visits:

As part of this study, adolescents will participate in four assessment visits at baseline and 4, 12, and 24 weeks following onboarding to the study intervention. Assessments cover a range of topics including mood, anxiety, suicidal thoughts and behaviors, and social media use and experience. At the time of the baseline visit, youth will be selected to receive either Flourish+Questionnaires (intervention condition) or Questionnaires Alone (control condition). Selection will occur through randomization, referring essentially to asking a computer to "flip a coin" to decide which group the participant will be assigned to.

Control Condition: Questionnaires Alone Youth in the control condition will be onboarded to a chatbot by a study clinician. A chatbot refers to an automated intervention that leverages chat-based conversations to communicate intervention content. This chatbot is designed solely to send structured brief questionnaires about online interactions via text messaging. Questionnaires assess the presence of negative/bullying interactions and positive/supportive interactions, once every 3 days. Mirroring the intervention condition, youth will receive this simplified chatbot for 4 weeks. If youth endorse negative/bullying interactions, they will be provided with information for crisis contacts (e.g., crisis hotline information).

Intervention Condition: Flourish Flourish is a chatbot that will aim to improve adolescents' capacity to cope following cyberbullying and reduce their suicidal risk. The duration of Flourish is 4 weeks. Flourish is designed to be self-paced with branching logic, aiming to provide the right type of support at the right time youth need it. Therefore, 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. Prior to initiating Flourish, adolescents and their caregivers will participate in a session of approximately 30 minutes with a study clinician in which they will onboard to Flourish. During onboarding, the clinician will orient the adolescent to Flourish and load information onto Flourish that will be available to the adolescent throughout their use of the intervention. This will include personal crisis contacts, such as trusted adults and crisis hotlines they could contact in the event of a crisis, as well as contacts for people they could reach out to for support or distraction outside of a crisis situation, such as a close friend or a family member. Adolescents will additionally enter information to personalize their experience with Flourish, such as entering preferences for coping skills that work best for them. During the onboarding process, caregivers will be provided with resources to respond to cyberbullying as well as information on their child's personal crisis resources.

Questionnaires through Flourish. Youth in the intervention group will receive questionnaires evaluating online experiences mirroring those received by the control group. If adolescents indicate negative interactions, Flourish will automatically launch providing supportive resources including crisis resources. If adolescents indicate supportive interactions (or no interactions), they will be given the option to launch Flourish to practice their coping skills, so they are prepared to respond to future cyberbullying events.

Resource Website for Flourish. Participants receiving Flourish will also have access to an accompanying website. The website will not collect or store any private information from the participant, and the participant will not interact with the website. It is a publicly available website that provides a list of resources participants may use, if needed. For example, this will include youth mental health organizations and organizations that provide education, support, and advocacy for youth who have experienced cyberbullying.

Social Media Data Collection and Feedback. Youth in both groups (Flourish+questionnaires and Questionnaires Alone) will have the option to provide their social media archives as part of the study. Software will strip identifiable information (e.g., names, dates of birth, locations, etc.) to the extent possible from the archives. Archives will be analyzed using software that detects presence of positive and negative social interactions. Those assigned to Flourish+Questionnaires will receive feedback from their online interactions, which is anticipated to help youth gain recognition and awareness of their online environment. ;

Related Conditions & MeSH terms

• Psychological Distress
• Suicidal Ideation
• Suicide
• Suicide Prevention

• NCT number: NCT06002191
• Study type: Interventional
• Source: University of Pittsburgh
• Contact: Candice L Biernesser, PhD
• Phone: 412-586-9064
• Email: lubbertcl@upmc.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Completion date: August 2026