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Using Information and Communication Technologies to Prevent Suicide in Chile

Primary Purpose

Suicide, Adolescent Behavior

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICT-based intervention
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Suicide prevention, Information and Communication Technologies, Cluster Randomized Controlled Trial, Latin America

Eligibility Criteria

14 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Students who attend participating public high schools in two cities (Santiago and Rancagua) of Chile

Exclusion Criteria:

  • Students having visual or physical impairments that are incompatible with the intervention model
  • Student having a prior diagnosis of a mental disorder.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    The ICT-based intervention is known as "Project Clan." Each participant randomized to the intervention group will have access to the web platform and mobile applications of "Project Clan" - a virtual community that seeks to promote adolescent mental health and wellbeing as students interact, express themselves, and resolve concerns, with the support of peers and mental health professionals. During the three-month intervention, participants will have complete anonymity, unless trained psychologists supervising the platform as "community counselors" identify behaviors associated with suicide risk and proceed to follow an established emergency protocol. The counselors will be available to answer community questions and provide support on an individual basis.

    Participants in the control group will also be assigned a username and password to access the website, but they will be met with a user interface that only displays a space to answer the corresponding assessments. In addition to the introductory presentation, they will be given a brochure with information regarding adolescent suicide and wellbeing and tips with regard to seeking help and assisting others. This will include the contact information for a telephone hotline, to ensure they can receive professional help if needed.

    Outcomes

    Primary Outcome Measures

    Okasha Suicidality Questionnaire
    Self-administered instrument exploring suicidal ideation and beliefs about suicide. Previously linked to suicide intent, depression, despair, low-self-esteem, impulsivity, and low social support. Item is sensitive to identifying immediate risk for suicide attempt. 4 items (scale 0-3; scale range= 0-12).

    Secondary Outcome Measures

    Coopersmith Self- Esteem Inventory
    Self-report scale on self-esteem among youth and adolescents in personal and social contexts. 58 items (scale 0-1).
    Barratt Impulsiveness Scale
    Self-report scale assessing cognitive, motor, and not planned impulsivity. 30 items (scale 0-4).
    General Self-Efficacy Scale
    Self-report scale assessing self-efficacy among youth across a number of daily stressors. 10 items (scale 1-3).
    Coping Across Situations Questionnaire
    Self-report scale assessing stress coping strategies among youth. 16 items. (scale 1-5).
    Perceived Social Support Scale
    Self-report scale assessing emotional help and advice among youth. 12 items (scale 1-5)
    Social Skills Scale
    Self-report scale assessing social skills through self-expression of anger or compliance in different scenarios. 33 items (scale 1-4).
    Depression Anxiety Stress scales
    Self-report scale assessing depression, anxiety, and stress symptoms. 21 items (scale 0-3).
    Discrimination and Devaluation Scale
    Self-report scale assessing awareness of stereotyping attitudes towards mental illness (12 items) (scale 0-3).

    Full Information

    First Posted
    April 8, 2018
    Last Updated
    May 2, 2018
    Sponsor
    University of Chile
    Collaborators
    Ministry of Health, Chile
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03514004
    Brief Title
    Using Information and Communication Technologies to Prevent Suicide in Chile
    Official Title
    Using Information and Communication Technologies to Prevent Suicide Among Secondary School Students in Two Regions of Chile: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 30, 2018 (Anticipated)
    Primary Completion Date
    September 30, 2018 (Anticipated)
    Study Completion Date
    November 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Chile
    Collaborators
    Ministry of Health, Chile

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A cluster randomized controlled trial (RCT) of a program based on information and communication technologies (ICT) will be conducted to prevent suicide and strengthen mental health among secondary school students in Chile. The program utilizes a web-based platform and a mobile application to cultivate a virtual community to promote mental health protective factors, such as self-esteem and self-expression, and reduce suicide risk. It is based on the principles of peer-support and inclusivity, and it has been inspired by previous studies in Europe and the US. The trial will take place in six public secondary schools in two cities of Chile: Santiago and Rancagua. Schools will be randomly assigned to either intervention or control conditions. Assessment will be conducted at baseline, 3-month (post intervention), and at 5-months (2 month follow-up).
    Detailed Description
    There is increasing concern regarding adolescent suicide in Latin America. Recent mental health policies foster the development and implementation of preventive interventions for suicide. Such initiatives, however, have been scarcely developed, even in countries with solid mental health services, such as Chile. The use of information and communication technologies (ICT) might contribute to create accessible, engaging, and innovative platforms to promote well-being and support for adolescents with mental health needs and suicide risk. Promising evidence from high-income countries has already shown the potential benefits of ICT-based programs but further research is needed, especially in settings with restrained resources. Providing local evidence is crucial for persuading policy makers and other stakeholders, and it will prove crucial in order to widely disseminate and scale up the program, if it is found to be effective. A cluster randomized controlled trial (RCT) to evaluate an ICT-based program will be conducted to prevent suicide and enhance mental health among adolescents in Chile. Four-hundred high-school students will be recruited from 6 public schools in two regions of Chile. Study procedures will be as follows: 1) design of the intervention model and creation of prototype; 2) selection and randomization of the participating schools; 3) implementation of the 3-month intervention and evaluation at baseline, post-intervention period, and a 2-month follow-up. The ICT-based program utilizes a web-based platform and a mobile application to cultivate a virtual community to promote mental health protective factors, such as self-esteem and self-expression, and prevent adolescent suicide. To overcome the frequent barriers to help seeking, the program will provide rapid direct access to quality, evidence-based information and real-time assistance from a mental health professional; encourage habits that improve emotional and physical health; facilitate self-monitoring of mental health and personal progress; and promote social integration and participation in community-based activities. The program is based on the principles of peer support and inclusivity, and as such, its name is "Project Clan," in reference to a diverse group of individuals who come together for a common purpose in a welcoming environment. The privacy and anonymity of each "Clan member" will be respected, so that they feel free to openly express themselves and resolve questions about possibly taboo topics related to mental health and suicide. Project Clan includes both informational and interactive features, ranging from traditional suicide prevention strategies (e.g., a chat with a psychologist, emergency phone hotline, and tips) that seek to reduce barriers to access quality, useful, and evidence-based information and rapid professional assistance; to components designed to increase interactions between participants and promote a sense of belonging and connection with the other Clan members. Suicidal ideation is the primary outcome in this study. Secondary outcomes include negative psychological outcomes (e.g., stigma, depression, anxiety) as well as a number of protective psychological and social factors. Indicators regarding the study implementation process will be also gathered. Pertinent study documents (e.g., research protocol, instruments, informed consent, and informed assent forms) were approved by the Ethics Committee for Human Subjects Research of the Faculty of Medicine, Universidad de Chile.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide, Adolescent Behavior
    Keywords
    Suicide prevention, Information and Communication Technologies, Cluster Randomized Controlled Trial, Latin America

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The ICT-based intervention is known as "Project Clan." Each participant randomized to the intervention group will have access to the web platform and mobile applications of "Project Clan" - a virtual community that seeks to promote adolescent mental health and wellbeing as students interact, express themselves, and resolve concerns, with the support of peers and mental health professionals. During the three-month intervention, participants will have complete anonymity, unless trained psychologists supervising the platform as "community counselors" identify behaviors associated with suicide risk and proceed to follow an established emergency protocol. The counselors will be available to answer community questions and provide support on an individual basis.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Participants in the control group will also be assigned a username and password to access the website, but they will be met with a user interface that only displays a space to answer the corresponding assessments. In addition to the introductory presentation, they will be given a brochure with information regarding adolescent suicide and wellbeing and tips with regard to seeking help and assisting others. This will include the contact information for a telephone hotline, to ensure they can receive professional help if needed.
    Intervention Type
    Behavioral
    Intervention Name(s)
    ICT-based intervention
    Other Intervention Name(s)
    Project Clan
    Intervention Description
    The ICT-based intervention, known as "Project Clan," includes both a web-platform and a mobile application. Project Clan includes both informational and interactive features, ranging from traditional suicide prevention strategies (e.g., a chat with a psychologist, emergency phone hotline, and tips) that seek to reduce barriers to access quality, useful, and evidence-based information and rapid professional assistance, to components designed to increase interactions between participants and promote a sense of belonging and connection with the other "Clan" members.
    Primary Outcome Measure Information:
    Title
    Okasha Suicidality Questionnaire
    Description
    Self-administered instrument exploring suicidal ideation and beliefs about suicide. Previously linked to suicide intent, depression, despair, low-self-esteem, impulsivity, and low social support. Item is sensitive to identifying immediate risk for suicide attempt. 4 items (scale 0-3; scale range= 0-12).
    Time Frame
    change from baseline suicidality at 5-month follow up
    Secondary Outcome Measure Information:
    Title
    Coopersmith Self- Esteem Inventory
    Description
    Self-report scale on self-esteem among youth and adolescents in personal and social contexts. 58 items (scale 0-1).
    Time Frame
    change from baseline self-esteem at 5-month follow up
    Title
    Barratt Impulsiveness Scale
    Description
    Self-report scale assessing cognitive, motor, and not planned impulsivity. 30 items (scale 0-4).
    Time Frame
    change from baseline impulsiveness at 5-month follow up
    Title
    General Self-Efficacy Scale
    Description
    Self-report scale assessing self-efficacy among youth across a number of daily stressors. 10 items (scale 1-3).
    Time Frame
    change from baseline self-efficacy at 5-month follow up
    Title
    Coping Across Situations Questionnaire
    Description
    Self-report scale assessing stress coping strategies among youth. 16 items. (scale 1-5).
    Time Frame
    change from baseline coping at 5-month follow up
    Title
    Perceived Social Support Scale
    Description
    Self-report scale assessing emotional help and advice among youth. 12 items (scale 1-5)
    Time Frame
    change from baseline perceived social support at 5-month follow up
    Title
    Social Skills Scale
    Description
    Self-report scale assessing social skills through self-expression of anger or compliance in different scenarios. 33 items (scale 1-4).
    Time Frame
    change from baseline social skills at 5-month follow up
    Title
    Depression Anxiety Stress scales
    Description
    Self-report scale assessing depression, anxiety, and stress symptoms. 21 items (scale 0-3).
    Time Frame
    change from baseline anxiety-depression-stress at 5-month follow up
    Title
    Discrimination and Devaluation Scale
    Description
    Self-report scale assessing awareness of stereotyping attitudes towards mental illness (12 items) (scale 0-3).
    Time Frame
    change from baseline discrimination-devaluation at 5-month follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - Students who attend participating public high schools in two cities (Santiago and Rancagua) of Chile Exclusion Criteria: Students having visual or physical impairments that are incompatible with the intervention model Student having a prior diagnosis of a mental disorder.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Given our commitment to the relevancy of this study, we agree to: Register this study at ClinicalTrials.gov. This record will be updated at least every 12 months, as required. Report aggregate results no later than one year after the clinical trial completion date, in a publication. Furthermore, the University of Chile (UCH) has an internal policy to ensure that clinical trials comply with University and sponsor policy and regulatory standards.
    Citations:
    PubMed Identifier
    29922187
    Citation
    Mascayano F, Schilling S, Tapia E, Santander F, Burrone MS, Yang LH, Alvarado R. Using Information and Communication Technologies to Prevent Suicide Among Secondary School Students in Two Regions of Chile: A Randomized Controlled Trial. Front Psychiatry. 2018 Jun 5;9:236. doi: 10.3389/fpsyt.2018.00236. eCollection 2018.
    Results Reference
    derived

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