Psychological DistressNCT05724784
Development and Feasibility Testing of a Suicide Prevention Intervention for Sexual and Gender Minority Youth
A study testing Flourish in people with Psychological Distress and Suicidal Ideation, run by University of Pittsburgh at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psychological Distress, Suicidal Ideation
- What is being tested?
- Flourish
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
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:
Read more
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.
Read the detailed 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).
- Conditions
- Psychological Distress, Suicidal Ideation
- Being tested
- Flourish
- Medical subject headings
- Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlourishBehavioural
Flourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth.
| Study group | Role | What they receive |
|---|---|---|
| Flourish | Experimental | 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. Receives: Behavioral: Flourish |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed upon recruitment to the study
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.
Measured: Assessed upon completion of the Week 12 study visits
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.
Measured: Assessed upon completion of the 4-week intervention period
Secondary outcomes (6)
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.
Measured: Assessed at the baseline and Week 4 follow-up assessment visits.
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.
Measured: Assessed at the Week 12 follow-up assessment visits.
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.
Measured: Assessed at baseline and Week 4 follow-up assessment visits.
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.
Measured: Assessed at baseline and Week 12 follow-up assessment visits.
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.
Measured: Assessed at the baseline and Week 4 assessment visits.
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.
Measured: Assessed at the baseline and Week 12 Follow-up assessment visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start24 May 2023
- Primary completion16 Oct 2023
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study design is an open trial.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Candice Biernesser, University of Pittsburgh
- Investigators
- Candice L Biernesser, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724784
- Sponsor's protocol ID
- STUDY22120062
- Status last verified
- Oct 2024
- First submitted
- 27 Jan 2023
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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 SGM adolescents.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Feasibility Testing of a Suicide Prevention Intervention for Sexual and Gender Minority Youth
- ClinicalTrials.gov ID
- NCT05724784
- Acronym / sponsor ID
- STUDY22120062
- Conditions
- Psychological Distress, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 24 May 2023 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study design is an open trial.
| Arm | Type | Receives |
|---|---|---|
| Flourish | Experimental | Behavioral: FlourishParticipants 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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlourishFlourish is a text messaging program that aims to improve coping following cyberbullying and reduce suicide risk among youth. | Behavioural | Flourish |
Primary outcome
Recruitment rates of eligible participants
Time frame: Assessed upon recruitment to the study
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
Time frame: Assessed upon completion of the Week 12 study visits
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
Time frame: Assessed upon completion of the 4-week intervention period
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.
6 secondary outcomes
Change in psychological distress from baseline to 4 weeks
Time frame: Assessed at the baseline and Week 4 follow-up assessment visits.
Change in psychological distress from baseline to 4 weeks
Time frame: Assessed at the Week 12 follow-up assessment visits.
Change in severity of suicidal ideation and behavior from baseline to 4 weeks
Time frame: Assessed at baseline and Week 4 follow-up assessment visits.
Change in severity of suicidal ideation and behavior from baseline to 12 weeks
Time frame: Assessed at baseline and Week 12 follow-up assessment visits.
Change in suicidal ideation from baseline to 4 weeks
Time frame: Assessed at the baseline and Week 4 assessment visits.
Change in suicidal ideation from baseline to 12 weeks
Time frame: Assessed at the baseline and Week 12 Follow-up assessment visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
- Individual participant dataSharing planned: Yes. 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 SGM adolescents.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Candice L Biernesser, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourish in people with Psychological Distress and Suicidal Ideation, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates of eligible participants (time frame: Assessed upon recruitment to the study). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024.