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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06002191
• Other study ID #: STUDY22070044
• Secondary ID: K23MH131759
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2023
• Est. completion date: August 2026

Study information

• Verified date: November 2023
• Source: University of Pittsburgh
• Contact: Candice L Biernesser, PhD
• Phone: 412-586-9064
• Email: lubbertcl[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychological Distress
• Suicidal Ideation
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Flourish
Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
• Questionnaires of Online Experiences
Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in distress tolerance from baseline to 4 weeks	Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.	Assessed at the baseline and Week 4 assessment visits
Other	Change in distress tolerance from baseline to 12 weeks	Distress tolerance will be measured by the Distress Tolerance Scale. The total score for this scale ranges from 15 to 75 with higher scores indicating higher levels of distress tolerance and lower scores indicating lower distress tolerance.	Assessed at the baseline and Week 12 assessment visit
Other	Change in motivation for help-seeking from baseline to 4 weeks	Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).	Assessed at the baseline and Week 4 assessment visits
Other	Change in motivation for help-seeking from baseline to 12 weeks	Motivation for help-seeking will be measured by Readiness, Importance, and Confidence rulers. This includes three rulers assessing readiness, importance, and confidence in help-seeking following cyberbullying. Scores for each ruler range from 0 (not at all ready) to 10 (very ready).	Assessed at the baseline and Week 12 follow-up assessment visits
Other	Change in social problem-solving from baseline to 4 weeks	Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.	Assessed at baseline and Week 4 assessment visits
Other	Change in social problem-solving from baseline to 12 weeks	Social problem-solving will be measured by the revised, short version of the Social Problem-Solving Inventory. This scale has a total score from 0 to 100 with higher scores indicating more effective problem-solving and lower scores representing a less effective problem-solving.	Assessed at the baseline and Week 12 assessment visits
Primary	Recruitment rates of eligible participants	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
Primary	Retention rates of eligible participants	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
Primary	Level of intervention usage	Usage of the intervention will be assessed by engagement with the text messaging intervention one or more times during the study period. A cut-off score of 70% of youth using the intervention one or more times will be used as a minimum requirement for acceptable usage.	Assessed upon completion of the 4-week intervention period
Secondary	Change in psychological distress from baseline to 4 weeks	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 4 follow-up assessment visits
Secondary	Change in psychological distress from baseline to 12 weeks	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
Secondary	Change in severity of suicidal ideation and behavior from baseline to 4 weeks	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
Secondary	Change in severity of suicidal ideation and behavior from baseline to 12 weeks	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
Secondary	Change in suicidal ideation from baseline to 4 weeks	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
Secondary	Change in suicidal ideation from baseline to 12 weeks	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