search
Back to results

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

Primary Purpose

Psychological Distress, Suicidal Ideation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flourish
Questionnaires of Online Experiences
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Distress

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flourish + Questionnaires

Questionnaires Alone

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 10, 2023
Last Updated
August 18, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)
search

1. Study Identification

Unique Protocol Identification Number
NCT06002191
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2025 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Distress, Suicidal Ideation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study design is a randomized controlled trial.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flourish + Questionnaires
Arm Type
Experimental
Arm Description
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.
Arm Title
Questionnaires Alone
Arm Type
Active Comparator
Arm Description
Participants will be onboarded to a text message program that solely will send participants brief questionnaires evaluating their online experiences once every 3 days.
Intervention Type
Behavioral
Intervention Name(s)
Flourish
Intervention Description
Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
Intervention Type
Behavioral
Intervention Name(s)
Questionnaires of Online Experiences
Intervention Description
Adolescents will receive brief questionnaires related to their online experiences and the impact those experiences have had on their stress level.
Primary Outcome Measure Information:
Title
Recruitment rates of eligible participants
Description
Feasibility will be measured through recruitment rates of eligible participants, using a cut-off score of 80% for desirable recruitment rates.
Time Frame
Assessed upon recruitment to the study
Title
Retention rates of eligible participants
Description
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.
Time Frame
Assessed upon completion of the Week 12 study visits
Title
Level of intervention usage
Description
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.
Time Frame
Assessed upon completion of the 4-week intervention period
Secondary Outcome Measure Information:
Title
Change in psychological distress from baseline to 4 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 4 follow-up assessment visits
Title
Change in psychological distress from baseline to 12 weeks
Description
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.
Time Frame
Assessed at the Week 12 follow-up assessment visits
Title
Change in severity of suicidal ideation and behavior from baseline to 4 weeks
Description
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.
Time Frame
Assessed at baseline and Week 4 follow-up assessment visits
Title
Change in severity of suicidal ideation and behavior from baseline to 12 weeks
Description
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.
Time Frame
Assessed at baseline and Week 12 follow-up assessment visits
Title
Change in suicidal ideation from baseline to 4 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 4 assessment visits
Title
Change in suicidal ideation from baseline to 12 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 12 Follow-up assessment visits
Other Pre-specified Outcome Measures:
Title
Change in distress tolerance from baseline to 4 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 4 assessment visits
Title
Change in distress tolerance from baseline to 12 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 12 assessment visit
Title
Change in motivation for help-seeking from baseline to 4 weeks
Description
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).
Time Frame
Assessed at the baseline and Week 4 assessment visits
Title
Change in motivation for help-seeking from baseline to 12 weeks
Description
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).
Time Frame
Assessed at the baseline and Week 12 follow-up assessment visits
Title
Change in social problem-solving from baseline to 4 weeks
Description
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.
Time Frame
Assessed at baseline and Week 4 assessment visits
Title
Change in social problem-solving from baseline to 12 weeks
Description
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.
Time Frame
Assessed at the baseline and Week 12 assessment visits

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candice L Biernesser, PhD
Phone
412-586-9064
Email
lubbertcl@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Candice L Biernesser, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data from enrolled participants may be shared with investigators within and outside of the University of Pittsburgh and University of Pittsburgh Medical Center for the purpose of studying cyberbullying or suicide risk among adolescents. Data sharing will be consistent with International Committee of Medical Journal Editors (ICMJE) requirements.
IPD Sharing Time Frame
These data will be released following acceptance of the project's main outcomes manuscript.
IPD Sharing Access Criteria
Data requests may be sent to the PI for review, who will provide data to interested and qualified investigators.

Learn more about this trial

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

We'll reach out to this number within 24 hrs