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SuicideNCT03514004

Using Information and Communication Technologies to Prevent Suicide in Chile

A study testing ICT-based intervention in people with Suicide and Adolescent Behavior, run by University of Chile.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Suicide, Adolescent Behavior
What is being tested?
ICT-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
30 May 2018to 1 Nov 2018
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 14 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Using Information and Communication Technologies to Prevent Suicide Among Secondary School Students in Two Regions of Chile: a Randomized Controlled Trial

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).

Read the 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.

Being tested
ICT-based intervention
Keywords
Suicide prevention, Information and Communication Technologies, Cluster Randomized Controlled Trial, Latin America
Medical subject headings
Suicide, Adolescent Behavior, Suicide Prevention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICT-based interventionBehavioural

    Also called Project Clan

    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.

Study groups in NCT03514004
Study groupRoleWhat they receive
InterventionExperimentalThe 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.
Receives: Behavioral: ICT-based intervention
ControlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: change from baseline suicidality at 5-month follow up

Secondary outcomes (8)
  1. Coopersmith Self- Esteem Inventory

    Self-report scale on self-esteem among youth and adolescents in personal and social contexts. 58 items (scale 0-1).

    Measured: change from baseline self-esteem at 5-month follow up

  2. Barratt Impulsiveness Scale

    Self-report scale assessing cognitive, motor, and not planned impulsivity. 30 items (scale 0-4).

    Measured: change from baseline impulsiveness at 5-month follow up

  3. General Self-Efficacy Scale

    Self-report scale assessing self-efficacy among youth across a number of daily stressors. 10 items (scale 1-3).

    Measured: change from baseline self-efficacy at 5-month follow up

  4. Coping Across Situations Questionnaire

    Self-report scale assessing stress coping strategies among youth. 16 items. (scale 1-5).

    Measured: change from baseline coping at 5-month follow up

  5. Perceived Social Support Scale

    Self-report scale assessing emotional help and advice among youth. 12 items (scale 1-5)

    Measured: change from baseline perceived social support at 5-month follow up

  6. Social Skills Scale

    Self-report scale assessing social skills through self-expression of anger or compliance in different scenarios. 33 items (scale 1-4).

    Measured: change from baseline social skills at 5-month follow up

  7. Depression Anxiety Stress scales

    Self-report scale assessing depression, anxiety, and stress symptoms. 21 items (scale 0-3).

    Measured: change from baseline anxiety-depression-stress at 5-month follow up

  8. Discrimination and Devaluation Scale

    Self-report scale assessing awareness of stereotyping attitudes towards mental illness (12 items) (scale 0-3).

    Measured: change from baseline discrimination-devaluation at 5-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2018
  2. Study start30 May 2018 (estimated)
  3. Primary completion30 Sep 2018 (estimated)
  4. Study completion1 Nov 2018 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03514004
Sponsor's protocol ID
ID16I10060
Status last verified
May 2018
First submitted
8 Apr 2018
Last updated
8 May 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Given our commitment to the relevancy of this study, we agree to: 1. Register this study at ClinicalTrials.gov. This record will be updated at least every 12 months, as required. 2. 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.

Publications

  • 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.

    PubMed 29922187

Questions about this trial

What is this clinical trial studying?

A study testing ICT-based intervention in people with Suicide and Adolescent Behavior, run by University of Chile.

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 1 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: status not confirmed, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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?

Okasha Suicidality Questionnaire (time frame: change from baseline suicidality at 5-month follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514004, which also lists 1 linked publication.

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 8 May 2018; AzTrials last refreshed its copy on 1 Nov 2026.

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