Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06651554
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-18
Brief Title:
Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Harnessing Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombian School Settings
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate a multi-level approach that applies technology-assisted methods to reduce suicidal thoughts and behaviors SIB and promote mental health among Colombian youth a digital platform for youth b digital platform for teachers and c hybrid mental health training diploma program for teachers This approach will evaluate technology-assisted methods in school settings to reduce gaps in access to evidence-based suicide prevention interventions in a low- and middle- income country The open-access digital platform was developed through a co-design process with Colombian youth to increase their sense of ownership of and engagement with the platform Key features of the digital platform include mental health self-help tools a customizable safety plan links to online counseling services and gamification elements The digital platforms teacher interface will incorporate psychoeducation brief suicide-risk screening and decision support tools to enhance teacher capacity to assess risk for suicide and refer youth to the appropriate level of services
Study investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota Colombia Study aims are to
Aim 1 An initial needs assessment will be conducted with key stakeholders youth teachers caregivers school administrators to identify barriers and facilitators to successful implementation of the multi-level approach Best practices in user-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype
Aim 2 Investigators will evaluate a feasibility acceptability and usability of the digital platform implemented across three schools in Colombia and b the preliminary effects of the digital platform in reducing SIB and improving mood eg anxietydepression among Colombian youth aged 14-19 attending the three schools Safety planning skills acquisition youth-level and linkages to mental health services service-level will be assessed as potential mechanisms of change
Aim 3 The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research healthcare delivery capacity and mental health policy In partnership with Pontificia Javeriana University experts in suicide prevention data science and implementation science will be engaged to build in-country research capacity at the individual and institutional level
Study investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota Colombia Study aims are to
Aim 1 An initial needs assessment will be conducted with key stakeholders youth teachers caregivers school administrators to identify barriers and facilitators to successful implementation of the multi-level approach Best practices in user-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype
Aim 2 Investigators will evaluate a feasibility acceptability and usability of the digital platform implemented across three schools in Colombia and b the preliminary effects of the digital platform in reducing SIB and improving mood eg anxietydepression among Colombian youth aged 14-19 attending the three schools Safety planning skills acquisition youth-level and linkages to mental health services service-level will be assessed as potential mechanisms of change
Aim 3 The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research healthcare delivery capacity and mental health policy In partnership with Pontificia Javeriana University experts in suicide prevention data science and implementation science will be engaged to build in-country research capacity at the individual and institutional level
Detailed Description:
This study uses a multi-level approach that leverages innovative culturally appropriate mHealth technology to reduce SIB and promote mental health in Colombian youth a digital platform for youth b digital platform for teachers and c hybrid mental health training diploma program for teachers We will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial to evaluate our digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota Colombia
Prior to launching the pilot trial study investigators will conduct an initial needs assessment with key stakeholders to identify barriers and facilitators to successful implementation of the digital platform Investigators will use a mixed methods approach and conduct qualitative interviews with key stakeholders teachers N10 youth N12 caregivers N5 and school administrators N3 Quantitative measures will include school climate leadership and attitudes towards technology-assisted interventions Qualitative data analysis will follow an iterative process of open coding for themes followed by focused coding to determine frequency of themes Mixed methods analysis will use joint displays to integrate qualitative and quantitative data and highlight key findings Results will inform development of a formal implementation blueprint that will be reviewed with key stakeholders and used to guide implementation of the digital platform
User-centered design methods will guide refinements of the youth interface and further development of the teacher interface in the digital platform The process will include two co-design workshops with youth N10 and two with teachers N8 Ender-user feedback from the initial co-design process will be incorporated to further optimize the digital platforms functionality and features to build the alpha prototype Three iterative user-testing sessions of the alpha prototype will be then be held with youth and teachers using think aloud protocols to elicit end-user feedback on features that are user-friendly versus confusing or hard to use Feedback from user-testing sessions will inform further refinements and development of the beta prototype Study investigators will then conduct three additional user-testing sessions with teachers and with youth respectively to test the beta prototype User-testing participants will complete the System Usability Scale after the last UIUX testing session to asses usability prior to launching the pilot trial
Aim 1 Exploration and Preparation Explore barriers and facilitators to successful implementation of the digital platform in Colombian schools A mixed-methods participatory process with key stakeholders will be used to identify implementation barriers and facilitators Aim 1a User-centered design principles will guide refinements of the digital platform
Aim 2 Implementation Conduct a hybrid type 1 implementation-effectiveness stepped wedge pilot trial to assess the feasibility acceptability usability and preliminary effects of the digital platform implemented within 3 schools in reducing SIB and improving mood eg anxietydepression among Colombian youth aged 14-19 N150 Study Hypotheses are that a the digital platform will be feasible acceptable and usable among youth and b youth who use the digital platform will exhibit greater reductions in SIB and mood symptoms during their schools intervention period compared with youth in the pre-intervention period no digital platform use at post-intervention and 3-month follow-up Aim 2a Explore safety planning skills youth-level and linkages to mental health services service-level as mechanisms of change We hypothesize that a use of the digital platform will be related to greater safety planning skills and service usage and b safety planning skills and service usage will be related to reduced SIB and mood symptoms
Study investigators will conduct a hybrid type 1 implementation-effectiveness stepped wedge pilot trial to evaluate digital platform implementation in Colombian schools A hybrid type 1 implementation-effectiveness design even if it is only a pilot study will support the evaluation of SIB and mood symptoms as primary outcomes with implementation outcomes as secondary Because there are signficant ethical and logistical issues posed by randomizing schools to a study condition a stepped wedge design is a pragmatic option that will allow for sequential transition of each school to the intervention condition in a randomized order The stepped wedge design has been used successfully in prior studies of school-based interventions in LMICs A complete stepped wedge design measures outcomes from all clusters eg schools at every data collection timepoint regardless of intervention exposure however due to resource and time constraints we propose an incomplete stepped wedge design in which study outcomes are measured at three timepoints for each school This pilot quasi-stepped wedge design allows us to gain experience with the stepped wedge procedures prior to implementing a fully powered trial with a stepped wedge design
The research team will recruit and enroll three secondary schools in Bogota to participate in the hybrid type 1 pilot stepped wedge trial Selection guidelines for schools will also include rules to minimize risk of contamination ie geographical distance between schools Enrolled schools will be randomized to a sequence which includes time exposed to the digital platform and mental health training program for teachers Intervention exposure periods will be 3-months in duration which will provide sufficient time for teachers to complete the hybrid mental health training program and for youth to access and use the digital platform as needed The research team will then recruit and enroll youth N228 76 per school and teachers N30 10 per school from enrolled schools with stratified selection to aim for gender balance in recruitment Youth and teachers will complete quantitative assessments during their schools baseline post-intervention and 3-month follow-up period
Digital platform implementation with youth and teachers there will be one initial in-person 1-hr introductory session with enrolled youth and one with teachers to provide an overview of the digital platforms features and functions Youth and teachers will have the opportunity to test out the digital platform and ask questions After the introductory session youth and teachers will be able to create an account to access the digital platform and use the different available tools as often as they choose at the time they choose during the 3-month intervention period Digital platform data will be stored in a HIPAA compliant could-based storage system and backed up on a HIPAA compliant server at Javeriana University All data will be deidentified to protect personal privacy and confidentiality of participants Technical assistance will be available to address any bugs or technology challenges encountered by participants
Central features of the digital platform include a integration with social media for easy youth access b authentication and guardian consent c mental health screening d linkages with online mental health counseling e customizable safety planning and f gamification elements The platform also includes self-help tools incorporating key components of evidence-based mental health interventions with a transdiagnostic focus ie cognitive-behavioral therapy mindfulness-based approaches that have shown effectiveness in reducing symptoms across a range of mental health disorders
Hybrid mental health teacher training program implemention Our certified teacher training program consists of 120 didactic hours across a 3-month period It includes six modules 1 Introduction to mental health and academic performance 2 Addressing emotions in childhood and adolescence 3 Substance use legal and illegal in children and adolescents and eating behavior 4 Aggressive behaviors and bullying in schools 5 Sexuality suspected sexual abuse and mistreatment 6 Inclusive education and resilience The second module contains evidence-based tools for identifying suicide risk and warning signs as well as to guide referrals for psychiatric emergency assessment andor other services The training program is completed with synchronous sessions as well as asychronous participation The duration of each module is about 2 weeks
Primary Outcomes will be measured via quantitative assessments at the youth participant level and include SIB depression anxiety well-being and safety planning skills Secondary Outcomes will be assessed at both the youth and teacher level and include feasibility acceptability usability and appropriateness of the digital platform via qualitative interviews conducted at post-intervention Teacher participant level mental health literacy sense of self-efficacy and satisfaction with the hybrid mental health training program will also be assessed via quantitative assessments All quantitative assessments will be administered at baseline post-intervention and 3-month follow-up
Prior to launching the pilot trial study investigators will conduct an initial needs assessment with key stakeholders to identify barriers and facilitators to successful implementation of the digital platform Investigators will use a mixed methods approach and conduct qualitative interviews with key stakeholders teachers N10 youth N12 caregivers N5 and school administrators N3 Quantitative measures will include school climate leadership and attitudes towards technology-assisted interventions Qualitative data analysis will follow an iterative process of open coding for themes followed by focused coding to determine frequency of themes Mixed methods analysis will use joint displays to integrate qualitative and quantitative data and highlight key findings Results will inform development of a formal implementation blueprint that will be reviewed with key stakeholders and used to guide implementation of the digital platform
User-centered design methods will guide refinements of the youth interface and further development of the teacher interface in the digital platform The process will include two co-design workshops with youth N10 and two with teachers N8 Ender-user feedback from the initial co-design process will be incorporated to further optimize the digital platforms functionality and features to build the alpha prototype Three iterative user-testing sessions of the alpha prototype will be then be held with youth and teachers using think aloud protocols to elicit end-user feedback on features that are user-friendly versus confusing or hard to use Feedback from user-testing sessions will inform further refinements and development of the beta prototype Study investigators will then conduct three additional user-testing sessions with teachers and with youth respectively to test the beta prototype User-testing participants will complete the System Usability Scale after the last UIUX testing session to asses usability prior to launching the pilot trial
Aim 1 Exploration and Preparation Explore barriers and facilitators to successful implementation of the digital platform in Colombian schools A mixed-methods participatory process with key stakeholders will be used to identify implementation barriers and facilitators Aim 1a User-centered design principles will guide refinements of the digital platform
Aim 2 Implementation Conduct a hybrid type 1 implementation-effectiveness stepped wedge pilot trial to assess the feasibility acceptability usability and preliminary effects of the digital platform implemented within 3 schools in reducing SIB and improving mood eg anxietydepression among Colombian youth aged 14-19 N150 Study Hypotheses are that a the digital platform will be feasible acceptable and usable among youth and b youth who use the digital platform will exhibit greater reductions in SIB and mood symptoms during their schools intervention period compared with youth in the pre-intervention period no digital platform use at post-intervention and 3-month follow-up Aim 2a Explore safety planning skills youth-level and linkages to mental health services service-level as mechanisms of change We hypothesize that a use of the digital platform will be related to greater safety planning skills and service usage and b safety planning skills and service usage will be related to reduced SIB and mood symptoms
Study investigators will conduct a hybrid type 1 implementation-effectiveness stepped wedge pilot trial to evaluate digital platform implementation in Colombian schools A hybrid type 1 implementation-effectiveness design even if it is only a pilot study will support the evaluation of SIB and mood symptoms as primary outcomes with implementation outcomes as secondary Because there are signficant ethical and logistical issues posed by randomizing schools to a study condition a stepped wedge design is a pragmatic option that will allow for sequential transition of each school to the intervention condition in a randomized order The stepped wedge design has been used successfully in prior studies of school-based interventions in LMICs A complete stepped wedge design measures outcomes from all clusters eg schools at every data collection timepoint regardless of intervention exposure however due to resource and time constraints we propose an incomplete stepped wedge design in which study outcomes are measured at three timepoints for each school This pilot quasi-stepped wedge design allows us to gain experience with the stepped wedge procedures prior to implementing a fully powered trial with a stepped wedge design
The research team will recruit and enroll three secondary schools in Bogota to participate in the hybrid type 1 pilot stepped wedge trial Selection guidelines for schools will also include rules to minimize risk of contamination ie geographical distance between schools Enrolled schools will be randomized to a sequence which includes time exposed to the digital platform and mental health training program for teachers Intervention exposure periods will be 3-months in duration which will provide sufficient time for teachers to complete the hybrid mental health training program and for youth to access and use the digital platform as needed The research team will then recruit and enroll youth N228 76 per school and teachers N30 10 per school from enrolled schools with stratified selection to aim for gender balance in recruitment Youth and teachers will complete quantitative assessments during their schools baseline post-intervention and 3-month follow-up period
Digital platform implementation with youth and teachers there will be one initial in-person 1-hr introductory session with enrolled youth and one with teachers to provide an overview of the digital platforms features and functions Youth and teachers will have the opportunity to test out the digital platform and ask questions After the introductory session youth and teachers will be able to create an account to access the digital platform and use the different available tools as often as they choose at the time they choose during the 3-month intervention period Digital platform data will be stored in a HIPAA compliant could-based storage system and backed up on a HIPAA compliant server at Javeriana University All data will be deidentified to protect personal privacy and confidentiality of participants Technical assistance will be available to address any bugs or technology challenges encountered by participants
Central features of the digital platform include a integration with social media for easy youth access b authentication and guardian consent c mental health screening d linkages with online mental health counseling e customizable safety planning and f gamification elements The platform also includes self-help tools incorporating key components of evidence-based mental health interventions with a transdiagnostic focus ie cognitive-behavioral therapy mindfulness-based approaches that have shown effectiveness in reducing symptoms across a range of mental health disorders
Hybrid mental health teacher training program implemention Our certified teacher training program consists of 120 didactic hours across a 3-month period It includes six modules 1 Introduction to mental health and academic performance 2 Addressing emotions in childhood and adolescence 3 Substance use legal and illegal in children and adolescents and eating behavior 4 Aggressive behaviors and bullying in schools 5 Sexuality suspected sexual abuse and mistreatment 6 Inclusive education and resilience The second module contains evidence-based tools for identifying suicide risk and warning signs as well as to guide referrals for psychiatric emergency assessment andor other services The training program is completed with synchronous sessions as well as asychronous participation The duration of each module is about 2 weeks
Primary Outcomes will be measured via quantitative assessments at the youth participant level and include SIB depression anxiety well-being and safety planning skills Secondary Outcomes will be assessed at both the youth and teacher level and include feasibility acceptability usability and appropriateness of the digital platform via qualitative interviews conducted at post-intervention Teacher participant level mental health literacy sense of self-efficacy and satisfaction with the hybrid mental health training program will also be assessed via quantitative assessments All quantitative assessments will be administered at baseline post-intervention and 3-month follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None