App-Based Intervention for Youth Well-Being and Resilience in Colombia (ShEdge-COL)

July 3, 2025 updated by: Sara Victoria Alvarado Salgado, Fundación Centro Internacional de Educación y Desarrollo Humano

Evaluation of a Digital Application and a Guide for Promoting Subjective Well-Being and Resilience in Colombian Youths: A Randomized Clinical Trial

This study evaluated the effectiveness of a mobile application called Shadow's Edge, with or without a printed self-awareness guide, in improving well-being and emotional resilience among Colombian youth aged 18 to 22. A total of 184 participants were randomly assigned to three groups: one used the app only, another used both the app and the guide, and a control group received delayed access. Participants completed psychological assessments before and after the intervention. The main outcomes included changes in well-being and resilience measured with standardized scales. Results showed that the app improved well-being and resilience in the short term. However, adding the guide did not produce additional benefits. The study highlights the potential of digital mental health tools in promoting emotional well-being among young people in low- and middle-income countries.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a randomized clinical trial designed to evaluate the effectiveness of a mobile mental health application (Shadow's Edge) and a printed self-awareness guide (GSEA - Guide to Self-Awareness) in improving subjective well-being and emotional resilience among Colombian youth. The study was conducted in response to the growing demand for accessible, evidence-based mental health tools in low- and middle-income countries (LMICs), where structural barriers such as inequality, poverty, and conflict limit access to traditional mental health services. The COVID-19 pandemic further highlighted the need for remote, scalable solutions to address emotional well-being in youth populations.

Shadow's Edge is a narrative-based digital tool developed by the nonprofit Digging Deep Project. It combines principles from narrative therapy, positive psychology, and existential psychology. Through writing prompts and creative expression in a post-apocalyptic fictional setting, users are guided to explore their emotions and build resilience. The game environment fosters engagement by allowing users to rebuild a city devastated by a storm-a metaphor for personal adversity. It has been previously evaluated in different contexts, with promising results in mental health promotion and resilience-building among adolescents.

The Guide to Self-Awareness (GSEA), developed as a printed complement to the app, incorporates socio-emotional learning strategies to deepen reflection. It includes structured exercises that promote mindfulness, emotional regulation, goal-setting, empathy, and communication skills. Both tools were culturally adapted to the Colombian context between 2021 and 2022, involving feedback from local adolescents and youth leaders.

A total of 305 young people expressed interest in the study through an open call disseminated via youth organizations. From these, 210 met the eligibility criteria and were randomized into three groups using the randomizeR package in R. The eligibility criteria included being between 18 and 22 years old, residing in Colombia for at least 6 months, and not being regular users of high-action video games (based on guidance from the app developers, who indicated that such users may have lower engagement with narrative-based tools). Participants with prior experience using Shadow's Edge were excluded. The final sample included 184 participants.

The groups were structured as follows:

App Group: Participants used Shadow's Edge only.

App + Guide Group: Participants used Shadow's Edge and completed exercises from the GSEA.

Control Group (Waitlist): Participants received delayed access to both tools after a second baseline measurement.

Data were collected using three validated instruments:

  • WHO-5 Well-Being Index (Campo-Arias et al., 2015 - Colombian validation): Measures subjective well-being over the last two weeks using five items on a Likert scale.
  • Abbreviated Resilience Scale (EAR) (Rodríguez-Rey et al., 2016 - Spanish validation): A six-item scale assessing perceived resilience.
  • Abbreviated Resilient Coping Scale (EAAR) (Trejos-Herrera et al., 2023 - Colombian validation): A four-item scale measuring resilient coping behaviors.

Measurements were taken in person at baseline and at 4 and 8 weeks for the intervention groups. The control group was evaluated four times: twice prior to gaining access to the tools and twice after. All instruments were administered in print. Compliance with the app usage was monitored via daily digital progress logs and backend usage data linked to anonymous codes. Participants were encouraged to use the app for at least 20 minutes daily.

Statistical analysis was conducted using mixed-effects regression models in R, controlling for group assignment, age, sex, and the number of words written in the app journal (used as a proxy for engagement). The analysis aimed to determine changes over time in each outcome measure, as well as between-group differences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia, 110221
        • Sede Bogotá

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 18 and 22 years at the time of enrollment
  • Resided in Colombia for at least 6 months prior to the start of the study
  • Provided informed consent to participate
  • Not a frequent user of high-action video games (e.g., first-person shooter or battle royale formats)
  • Had not previously used the Shadow's Edge mobile application

Exclusion Criteria:

  • Any participant sharing a household or close familial relationship with another enrolled participant (to prevent contamination across study arms)
  • Failure to meet any of the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: App only
Participants in this arm used only the Shadow's Edge mobile application. They were instructed to engage with the app for at least 20 minutes per day over an 8-week period. The app promotes emotional expression, self-reflection, and resilience through a narrative-based experience that includes writing prompts and creative activities.
Behavioral: Shadow's Edge mobile app
A mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience.
Experimental: App + Guide
Participants in this arm used both the Shadow's Edge mobile application and the printed Guide to Self-Awareness (GSEA). The intervention was delivered over 8 weeks, with daily use of the app and weekly completion of guided reflection activities. The guide was designed to enhance emotional insight, mindfulness, and social-emotional skills.
Behavioral: Shadow's Edge mobile app
A mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience.
Behavioral: Guide to Self-Awareness (GSEA)
A printed guide developed to promote emotional insight, mindfulness, self-awareness, and social-emotional skills through structured reflection activities. Designed to be used alongside the Shadow's Edge app.
No Intervention: Waitlist Control
Participants in this arm did not receive the intervention during the first two assessments. They were evaluated at two timepoints without access to the app or guide. After the second assessment, they received access to both the Shadow's Edge app and the GSEA for ethical and comparative purposes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in WHO-5 Well-Being Index Score
Time Frame: Baseline (Week 0), Week 4, and Week 8
The WHO-5 Well-Being Index is a 5-item self-report scale developed by the World Health Organization to assess subjective psychological well-being over the past two weeks. Each item is rated on a 6-point Likert scale ranging from 0 ("At no time") to 5 ("All of the time"). Total scores range from 0 to 25, with higher scores indicating better well-being. The instrument has been validated in Colombia (Campo-Arias et al., 2015) and is widely used in clinical trials. Changes in scores across the three measurement points (baseline, 4 weeks, and 8 weeks) will be used to assess the effectiveness of the intervention.
Baseline (Week 0), Week 4, and Week 8

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Abbreviated Resilience Scale (EAR) Score
Time Frame: Baseline (Week 0), Week 4, and Week 8
The Abbreviated Resilience Scale (EAR) is a 6-item self-report measure used to assess perceived resilience, including the ability to recover from stress. Each item is rated on a 5-point Likert scale. Total scores range from 6 to 30, with higher scores indicating greater resilience. The Spanish version validated in Colombia (Rodríguez-Rey et al., 2016) was used in this study. Scores were collected at baseline, week 4, and week 8 to assess changes in resilience across time and study groups.
Baseline (Week 0), Week 4, and Week 8
Change in Abbreviated Resilient Coping Scale (EAAR) Score
Time Frame: Baseline (Week 0), Week 4, and Week 8
The Abbreviated Resilient Coping Scale (EAAR) is a 4-item self-report measure designed to assess resilient coping behavior under stress. Each item is rated on a 5-point Likert scale, yielding total scores ranging from 4 to 20. Higher scores indicate stronger coping ability. The Colombian validation by Trejos-Herrera et al. (2023) was used in this study. Scores were obtained at three time points to analyze improvements in coping strategies over time.
Baseline (Week 0), Week 4, and Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundación Centro Internacional de Educación y Desarrollo Humano

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fondation Botnar (Switzerland)
The Digging Deep Project

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Orlando Scoppetta, Ph.D., Fundación Centro Internacional de Educación y Desarrollo Humano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 12, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SE-GSEA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) related to primary and secondary outcomes (WHO-5, EAR, and EAAR scores), collected at all time points.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the main findings and for up to 5 years thereafter.

IPD Sharing Access Criteria

Data will be made available to qualified researchers upon reasonable request for purposes consistent with the original study objectives. A data use agreement will be required.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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