Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251037
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-27
First Post:
2024-02-01
Brief Title:
Youth Aware of Mental Health in Galicia
Sponsor:
Fundacin Biomedica Galicia Sur
Organization:
Fundacin Biomedica Galicia Sur
Study Overview
Official Title:
Randomized Clinical Trial to Evaluate the Efficacy of the Universal Suicide Prevention Program Youth Aware of Mental Health in Galicia
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
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:
YAM
Brief Summary:
The goal of this interventional study is to assess the effectiveness of the universal suicide prevention program Youth Aware of Mental Health in 3rd-year secondary education students in Galicia
The main questions it aims to answer are
Is the YAM program effective in reducing severe suicidal ideation at 12 months from baseline within the experimental group and compared to the control group
Is the YAM program effective in preventing the incidence of new suicidal attempts 12 months from baseline in the experimental group compared to the control group
All participants in this study will be asked to
Complete a survey at baseline and after 12 months consisting of measures for suicidal ideation and behavior depressive symptoms seeking help behaviors bullying problematic internet use and emotional distress
Only those allocated to the experimental group will be asked to
Undergo the YAM program an evidence-based intervention structured into five one-hour class group sessions 45-50 min focused on problem-solving by peers The program consists of interactive presentations dilemma discussions role-playing and reflection all moderated by a trained YAM instructor
Twelve months after the intervention all participants will undergo a re-evaluation using the same protocol The researchers will compare differences in pre- and post-measures within the experimental and control groups as well as between both groups to assess the impact of the YAM intervention on outcomes such as suicidal ideation and attempts
At the end of the study those who were allocated to the control group are going to be offered the YAM intervention program
The main questions it aims to answer are
Is the YAM program effective in reducing severe suicidal ideation at 12 months from baseline within the experimental group and compared to the control group
Is the YAM program effective in preventing the incidence of new suicidal attempts 12 months from baseline in the experimental group compared to the control group
All participants in this study will be asked to
Complete a survey at baseline and after 12 months consisting of measures for suicidal ideation and behavior depressive symptoms seeking help behaviors bullying problematic internet use and emotional distress
Only those allocated to the experimental group will be asked to
Undergo the YAM program an evidence-based intervention structured into five one-hour class group sessions 45-50 min focused on problem-solving by peers The program consists of interactive presentations dilemma discussions role-playing and reflection all moderated by a trained YAM instructor
Twelve months after the intervention all participants will undergo a re-evaluation using the same protocol The researchers will compare differences in pre- and post-measures within the experimental and control groups as well as between both groups to assess the impact of the YAM intervention on outcomes such as suicidal ideation and attempts
At the end of the study those who were allocated to the control group are going to be offered the YAM intervention program
Detailed Description:
This multicenter study will be conducted in selected school centers including both public and private These centers were identified through two-stage stratified sampling based on the population distribution in which they are located and their ownership to be representative of the Galician population in Secondary Education ESO Participant randomization does not take place on an individual level Each clusters center is identified by a numerical code and assigned to each group intervention and control group using a random number generator
The operationalization of the study will consist of the following phases
Preparation
The educational authorities will convene a meeting with the directors or guidance departments of the respective centers In this meeting the coordinator of the YAM Team and the Principal Investigator of this study AGC will explain what YAM entails the implementation strategy and address any questions regarding deployment and logistics If deemed necessary an informative session for the parentsguardians of the students will be scheduled Subsequently the YAM instructor will contact the schools guidance counselor to arrange the dates for YAM In control group schools the same process will be followed but instead of the YAM intervention only the pre-test and post-test measures will be collected
Evaluation
An initial survey is going to be conducted to collect the measures of all participants The domains included in this survey will consist of socio-demographic data and measures of suicidal ideation and behavior depressive symptoms seeking help behaviors bullying problematic internet use and emotional distress Following the criteria used in the HBSC survey Health Behaviour in School-aged Children this evaluation is going to be conducted individually in class and ensuring participant anonymity
A specialized survey company using CAWI methodology will conduct the surveys ensuring compliance with the requirements outlined in Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 regarding the protection of individuals with regard to the processing of personal data and on the free movement of such data and with Organic Law 32018 of December 5 on the Protection of Personal Data and guarantee of digital rights The surveys will be anonymized each center will be identified with a numerical code and each participating student will be associated with a number Each student will receive this code at the time of the survey Neither the research team nor the teacher will be aware of the association between the students identity and the code and no list with such an association will be kept making it impossible to identify the student later The participation of minors in the clinical trial is regulated by Royal Decree 10902015 of December 4 which states that the authorization of parents guardians or legal custodians is mandatory In addition to this authorization for those over 12 years old the authorization of the minor is required and the intervention must be explained to them in appropriate terms
Intervention
Once the initial surveys are completed the YAM intervention will be carried out in the corresponding centers YAM is structured into 5 one-hour class sessions 45-50 min
Inaugural Session
Consists of an interactive slide presentation delivered by the YAM instructor laying the groundwork for the rest of the program In this first session the materials to be used are introduced 6 posters that will be present throughout the program are displayed in the classroom and students are given a user manual
Second session
The class group is presented with a series of dilemmas outlined on a set of cards to discuss in small groups These dilemmas are part of the everyday problems of a current school community The goal is for students to come to their own conclusions when solving problems rather than the instructor lecturing or solving dilemmas or problem situations
Third and fourth sessions
Contents related to crisis situations depression suicidal ideation and help-seeking behaviors are addressed through role-playing games allowing the class to integrate their experiences and newly acquired knowledge about mental health through experiential play reflection and group discussion In the role-play sessions three dilemmas chosen by the class group are addressed The objective is to discover
1 how the decisions made make them feel and what the result of those decisions and actions is
2 become aware of their own feelings and reflect on how to handle stress and crisis situations
3 listen to others and be able to talk about depression and suicidal thoughts
Closing Session
A collective summary of the topics is made and dynamic aspects relational and emotional arising during the group experience are addressed
The YAM intervention is manualized and all instructors will be recruited from educational and healthcare personnel with clinical experience in adolescents The instructor group will undergo a 1-week in-person course with the original Swedish team and a practice period before starting the implementation YAM instructors will also be specifically trained in the evaluation and management of contingencies related to the appearance of suicidal verbalizations among participants during the implementation of the course All adverse events will be reported to the schools guidance service and the YAM Team coordinator AGC who will jointly decide the steps to be taken in agreement with parents guardians or legal custodians following the Action and Prevention Protocol for Suicide Risk in the Health and Educational Environment for Children and Adolescents httpwwweduxuntagalportalnode38218
Follow up
One year after the intervention the students who participated in the first survey will be re-evaluated using the same system to collect post-measures
The operationalization of the study will consist of the following phases
Preparation
The educational authorities will convene a meeting with the directors or guidance departments of the respective centers In this meeting the coordinator of the YAM Team and the Principal Investigator of this study AGC will explain what YAM entails the implementation strategy and address any questions regarding deployment and logistics If deemed necessary an informative session for the parentsguardians of the students will be scheduled Subsequently the YAM instructor will contact the schools guidance counselor to arrange the dates for YAM In control group schools the same process will be followed but instead of the YAM intervention only the pre-test and post-test measures will be collected
Evaluation
An initial survey is going to be conducted to collect the measures of all participants The domains included in this survey will consist of socio-demographic data and measures of suicidal ideation and behavior depressive symptoms seeking help behaviors bullying problematic internet use and emotional distress Following the criteria used in the HBSC survey Health Behaviour in School-aged Children this evaluation is going to be conducted individually in class and ensuring participant anonymity
A specialized survey company using CAWI methodology will conduct the surveys ensuring compliance with the requirements outlined in Regulation EU 2016679 of the European Parliament and of the Council of April 27 2016 regarding the protection of individuals with regard to the processing of personal data and on the free movement of such data and with Organic Law 32018 of December 5 on the Protection of Personal Data and guarantee of digital rights The surveys will be anonymized each center will be identified with a numerical code and each participating student will be associated with a number Each student will receive this code at the time of the survey Neither the research team nor the teacher will be aware of the association between the students identity and the code and no list with such an association will be kept making it impossible to identify the student later The participation of minors in the clinical trial is regulated by Royal Decree 10902015 of December 4 which states that the authorization of parents guardians or legal custodians is mandatory In addition to this authorization for those over 12 years old the authorization of the minor is required and the intervention must be explained to them in appropriate terms
Intervention
Once the initial surveys are completed the YAM intervention will be carried out in the corresponding centers YAM is structured into 5 one-hour class sessions 45-50 min
Inaugural Session
Consists of an interactive slide presentation delivered by the YAM instructor laying the groundwork for the rest of the program In this first session the materials to be used are introduced 6 posters that will be present throughout the program are displayed in the classroom and students are given a user manual
Second session
The class group is presented with a series of dilemmas outlined on a set of cards to discuss in small groups These dilemmas are part of the everyday problems of a current school community The goal is for students to come to their own conclusions when solving problems rather than the instructor lecturing or solving dilemmas or problem situations
Third and fourth sessions
Contents related to crisis situations depression suicidal ideation and help-seeking behaviors are addressed through role-playing games allowing the class to integrate their experiences and newly acquired knowledge about mental health through experiential play reflection and group discussion In the role-play sessions three dilemmas chosen by the class group are addressed The objective is to discover
1 how the decisions made make them feel and what the result of those decisions and actions is
2 become aware of their own feelings and reflect on how to handle stress and crisis situations
3 listen to others and be able to talk about depression and suicidal thoughts
Closing Session
A collective summary of the topics is made and dynamic aspects relational and emotional arising during the group experience are addressed
The YAM intervention is manualized and all instructors will be recruited from educational and healthcare personnel with clinical experience in adolescents The instructor group will undergo a 1-week in-person course with the original Swedish team and a practice period before starting the implementation YAM instructors will also be specifically trained in the evaluation and management of contingencies related to the appearance of suicidal verbalizations among participants during the implementation of the course All adverse events will be reported to the schools guidance service and the YAM Team coordinator AGC who will jointly decide the steps to be taken in agreement with parents guardians or legal custodians following the Action and Prevention Protocol for Suicide Risk in the Health and Educational Environment for Children and Adolescents httpwwweduxuntagalportalnode38218
Follow up
One year after the intervention the students who participated in the first survey will be re-evaluated using the same system to collect post-measures
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