About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: Flourish + QuestionnairesExperimental treatment 2 interventions

Group B: Questionnaires AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Assessed upon recruitment to the study

2

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.

Time frame

Assessed upon completion of the Week 12 study visits

3

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.

Time frame

Assessed upon completion of the 4-week intervention period

Secondary outcomes

1

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.

Time frame

Assessed at the baseline and Week 4 follow-up assessment visits

2

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.

Time frame

Assessed at the Week 12 follow-up assessment visits

3

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.

Time frame

Assessed at baseline and Week 4 follow-up assessment visits

4

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.

Time frame

Assessed at baseline and Week 12 follow-up assessment visits

Other outcomes

1

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.

Time frame

Assessed at the baseline and Week 4 assessment visits

2

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.

Time frame

Assessed at the baseline and Week 12 assessment visit

3

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).

Time frame

Assessed at the baseline and Week 4 assessment visits

4

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).

Time frame

Assessed at the baseline and Week 12 follow-up assessment visits

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts