Development and Feasibility Testing of a Suicide Prevention Intervention for Sexual and Gender Minority Youth

Suicidal Ideation Clinical Trial

Official title:

Development and Feasibility Testing of a Suicide Prevention Intervention for Sexual and Gender Minority Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05724784
• Other study ID #: STUDY22120062
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: September 2024

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

This study aims to develop and test a brief, digital, suicide prevention intervention for sexual and gender minority (SGM) youth who have experienced cyberbullying. Leading up to this phase, the study team completed two prior study aims, focused on identifying perspectives of SGM youth's regarding their experiences with cyberbullying and priorities for an intervention, and a phase in which SGM youth codesigned the study's intervention with the study team. This resulted in the development of study's intervention, Flourish, which leverages a text messaging-based chatbot to reduce suicide risk following cyberbullying among SGM youth through improving distress tolerance, motivation for help-seeking, and social problem-solving.

Current Study Aim:

Conduct an open trial to assess the feasibility and acceptability of Flourish among cyberbullied SGM youth, ages 12-17 (N=10).

Hypotheses:

Feasibility will be evidenced by recruitment/retention rates > 80% and use of Flourish among > 70% of SGM youth.

At follow-up, adolescents will report improved problem-solving capacity, distress tolerance, and motivation for help-seeking and reduced psychological distress and suicidal ideation compared to baseline.

Description:

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 no less than 2-3 times per week.

Onboarding. 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 s as well as information on their child's personal crisis resources.

Launch. The research team will administer brief questionnaires to adolescents 2-3 times per week during the 4-week intervention period that assess positive/supportive and negative/bullying interactions on social media. If adolescents indicate negative interactions, Flourish will automatically launch. 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:

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 SGM mental health organizations and organizations that provide education, support, and advocacy for youth who have experienced cyberbullying.

Treatment Targets:

To reduce psychological distress and suicidal ideation, Flourish will deploy distress tolerance skills and utilize principles of problem-solving therapy and motivational interviewing.

Problem-Solving. Problem-solving therapy (PST) is a brief cognitive-behavioral intervention that aims to improve coping with stressful life events. PST has shown efficacy in reducing suicide risk among youth and has been successfully delivered in a self-guided online format. Flourish will target: problem identification by aiding youth in appraising the threat of the cyberbullying event they experienced and their socioemotional consequences, generation of potential solutions based on available resources for response, and decision-making through considering barriers and facilitators to putting solutions into action.

Motivation. Motivational Interviewing (MI) is a patient-centered approach that provides a framework for enhancing intrinsic motivation for change that has shown efficacy for improving help-seeking among youth at suicidal risk and has been used in digital mental health interventions. Flourish will incorporate the spirit of MI through its clinical style (i.e., collaborative, empowering language) and MI techniques through responses that are affirming, reflections to demonstrate the chatbot is listening, and offer simple summaries to evoke a change mindset. Flourish will engage strategies to support self-efficacy by focusing on confidence in help-seeking. Through a library of messages, refined to assure fidelity with MI principles, Flourish will elicit thoughts about seeking help following cyberbullying, assess readiness for behavior change through rulers that assess importance and confidence in change, and make a plan for help-seeking. Youth will be offered individualized feedback through stories of SGM adolescents' help-seeking experiences. Developed by writers in partnership with SGM youth, stories will target key motivational barriers to help-seeking following cyberbullying identified in the investigators' pilot data: trust, confidentiality, fear of negative appraisal, and disbelief that help will be effective. Stories will be tailored, i.e., offering examples for youth of differing ages, genders, and identities, and will consider experiences specific to SGM youth of color.

Distress Tolerance. Flourish will be designed to support adolescents' tolerance of distress in recognition that sustained distress experiences contribute to suicidal ideation and interfere with adaptive problem-solving. Flourish will lead youth in monitoring distress levels and respond with a coping skills library that leverages existing online content, focusing on distraction and self-soothing (e.g., guided meditation, breathing exercises, and savoring positive memories).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

Inclusion Criteria:

• self-reported SGM identity

• English-speaking

• access to a phone or device to complete the study's intervention

• past-month history of cyberbullying or online discrimination, assessed by the cybervictimization subscale of the traditional and cyberbullying victimization and perpetration scale or a discrimination measure developed as part of the Adolescent Brain and Cognitive Development (ABCD) study

• lifetime history of suicidal ideation or behavior (assessed by the Ask Suicide Screen)

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	American Foundation for Suicide Prevention

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 4assessment 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 4 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.