Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002191
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-08-10
Brief Title:
Development and Testing of ImHere4U a Digital Suicide Prevention Intervention for Cyberbullied Adolescents
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Development and Testing of ImHere4U a Digital Suicide Prevention Intervention for Cyberbullied Adolescents
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 FlourishQuestionnaires vs Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 N80 35 underserved youth
H2a Primary outcome Feasibility will be evidenced by recruitmentretention rates 80 and imHere4U engagement 70
H2b Secondary outcomes Youth assigned to FlourishQuestionnaires 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
The specific aims are to
Aim 1 Conduct a randomized controlled trial RCT comparing FlourishQuestionnaires vs Questionnaires Alone among cyberbullied youth at-risk for suicide ages 12-17 N80 35 underserved youth
H2a Primary outcome Feasibility will be evidenced by recruitmentretention rates 80 and imHere4U engagement 70
H2b Secondary outcomes Youth assigned to FlourishQuestionnaires 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 FlourishQuestionnaires 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 negativebullying interactions and positivesupportive interactions once every 3 days Mirroring the intervention condition youth will receive this simplified chatbot for 4 weeks If youth endorse negativebullying interactions they will be provided with information for crisis contacts eg 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 childs 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 Flourishquestionnaires and Questionnaires Alone will have the option to provide their social media archives as part of the study Software will strip identifiable information eg 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 FlourishQuestionnaires will receive feedback from their online interactions which is anticipated to help youth gain recognition and awareness of their online environment
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 FlourishQuestionnaires 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 negativebullying interactions and positivesupportive interactions once every 3 days Mirroring the intervention condition youth will receive this simplified chatbot for 4 weeks If youth endorse negativebullying interactions they will be provided with information for crisis contacts eg 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 childs 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 Flourishquestionnaires and Questionnaires Alone will have the option to provide their social media archives as part of the study Software will strip identifiable information eg 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 FlourishQuestionnaires will receive feedback from their online interactions which is anticipated to help youth gain recognition and awareness of their online environment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23MH131759 | NIH | None | httpsreporternihgovquickSearchK23MH131759 |