NCT03514004

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

May 30, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

April 8, 2018

Last Update Submit

May 2, 2018

Conditions

Keywords

Suicide preventionInformation and Communication TechnologiesCluster Randomized Controlled TrialLatin America

Outcome Measures

Primary Outcomes (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).

    change from baseline suicidality at 5-month follow up

Secondary Outcomes (8)

  • Coopersmith Self- Esteem Inventory

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

  • Barratt Impulsiveness Scale

    change from baseline impulsiveness at 5-month follow up

  • General Self-Efficacy Scale

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

  • Coping Across Situations Questionnaire

    change from baseline coping at 5-month follow up

  • Perceived Social Support Scale

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

  • +3 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: ICT-based intervention

Control

NO INTERVENTION

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.

Interventions

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.

Also known as: Project Clan
Intervention

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideAdolescent BehaviorSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, PhD

Study Record Dates

First Submitted

April 8, 2018

First Posted

May 2, 2018

Study Start

May 30, 2018

Primary Completion

September 30, 2018

Study Completion

November 1, 2018

Last Updated

May 8, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

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.