Clinical trial NCT06002191: Development and Testing of ImHere4U: a Digital Suicide Prevention Intervention for Cyberbullied Adolescents
Official title: Development and Testing of ImHere4U: a Digital Suicide Prevention Intervention for Cyberbullied Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Suicidal Ideation
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-21
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a randomized controlled trial.
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* English-speaking
* access to a phone or device capable of text messaging
* past 3-month history of cyberbullying assessed by the cybervictimization subscale of the Traditional Bullying and Cyberbullying Victimization and Perpetration Scale and/or presence of online discrimination measured by a modified version of a discrimination measured developed as part of the Adolescent Brain and Cognitive Development (ABCD) study
* 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)

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)
* acuity levels suggesting need for a higher level of care (e.g., inpatient hospitalization) or referral for emergency services

Primary outcomes:
measure: Recruitment rates of eligible participants
timeFrame: Assessed upon recruitment to the study
measure: Retention rates of eligible participants
timeFrame: Assessed upon completion of the Week 12 study visits
measure: Level of intervention usage
timeFrame: Assessed upon completion of the 4-week intervention period
Secondary outcomes:
measure: Change in psychological distress from baseline to 4 weeks
timeFrame: Assessed at the baseline and Week 4 follow-up assessment visits
measure: Change in psychological distress from baseline to 12 weeks
timeFrame: Assessed at the Week 12 follow-up assessment visits
measure: Change in severity of suicidal ideation and behavior from baseline to 4 weeks
timeFrame: Assessed at baseline and Week 4 follow-up assessment visits
measure: Change in severity of suicidal ideation and behavior from baseline to 12 weeks
timeFrame: Assessed at baseline and Week 12 follow-up assessment visits
measure: Change in suicidal ideation from baseline to 4 weeks
timeFrame: Assessed at the baseline and Week 4 assessment visits
measure: Change in suicidal ideation from baseline to 12 weeks
timeFrame: Assessed at the baseline and Week 12 Follow-up assessment visits
Other outcomes:
measure: Change in distress tolerance from baseline to 4 weeks
timeFrame: Assessed at the baseline and Week 4 assessment visits
measure: Change in distress tolerance from baseline to 12 weeks
timeFrame: Assessed at the baseline and Week 12 assessment visit
measure: Change in motivation for help-seeking from baseline to 4 weeks
timeFrame: Assessed at the baseline and Week 4 assessment visits
measure: Change in motivation for help-seeking from baseline to 12 weeks
timeFrame: Assessed at the baseline and Week 12 follow-up assessment visits
measure: Change in social problem-solving from baseline to 4 weeks
timeFrame: Assessed at baseline and Week 4 assessment visits
measure: Change in social problem-solving from baseline to 12 weeks
timeFrame: Assessed at the baseline and Week 12 assessment visits
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Candice L Biernesser, PhD
role: PRINCIPAL_INVESTIGATOR
References: