- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07063121
- Original Trial
App-Based Intervention for Youth Well-Being and Resilience in Colombia (ShEdge-COL)
Evaluation of a Digital Application and a Guide for Promoting Subjective Well-Being and Resilience in Colombian Youths: A Randomized Clinical Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bogotá, Colombia, 110221
- Sede Bogotá
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
A mobile application adapted for Colombian youth that uses interactive storytelling, journaling, and emotional regulation activities to promote subjective well-being and resilience.
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
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
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
Investigators
- Study Director: Orlando Scoppetta, Ph.D., Fundación Centro Internacional de Educación y Desarrollo Humano
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SE-GSEA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Emotional Resilience
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Enrolling by invitationEmotional ResilienceRomania
-
Babes-Bolyai UniversityThe Executive Agency for Higher Education, Research, Development and Innovation...Completed
-
University of ArizonaRecruitingEmotional Development | Mental and Behavioral Disorders | Mental Resilience | Emotional AwarenessUnited States
-
Alexandria UniversityRecruitingResilience-based Intervention, Emotional Regulation, Grit and Life SatisfactionEgypt
-
City University of Hong KongThe Hong Kong Jockey Club Charities Trust; International Social Services Hong...Recruiting
-
Queen's University, BelfastNot yet recruitingEmotional Regulation | Psychological Resilience | Substance Use Prevention | Mental Health Well-being
-
University of OttawaCompletedBurnout, Professional | Stress, Emotional | ResilienceCanada
-
Massachusetts General HospitalNational Center for Complementary and Integrative Health (NCCIH)RecruitingDepression | Anxiety | Emotional Distress | Resilience | Survivorship | Mindfulness | Caregivers | Cardiac Arrest (CA)United States
-
Emory UniversityCompletedBehavioral Resilience | Biological ResilienceUnited States
-
The Center for Mind-Body MedicineSimon Family FoundationCompleted
Clinical Trials on Shadow's Edge mobile app
-
Ann & Robert H Lurie Children's Hospital of ChicagoSilicon Valley Community FoundationCompletedCancer | Pediatric CancerUnited States
-
The University of Hong KongNorth District Hospital; Queen Mary Hospital, Hong Kong; Pamela Youde Nethersole... and other collaboratorsUnknownSelf Inflicted Injury | Suicide and Self Inflicted InjuryHong Kong
-
University of ValenciaMinistry of Science and InnovationCompleted
-
University of California, San FranciscoSan Francisco Veterans Affairs Medical CenterCompletedPost Traumatic Stress DisorderUnited States
-
Duke UniversityDuke Institute for Health InnovationCompleted
-
Tan Tock Seng HospitalNanyang Technological University; Geriatric Education and Research InstituteEnrolling by invitationCognitive DeclineSingapore
-
University of ZurichSwitzerland: ETH; Switzerland: MakoraCompleted
-
Weill Medical College of Cornell UniversityChildren's Health FundRecruitingDepression | Bipolar Disorder | Anxiety Disorders and Symptoms | SymptomsUnited States
-
Aarhus University HospitalRecruitingTic DisordersDenmark
-
Ksana HealthNovo Nordisk A/SCompletedObesity | Overweight | Mental Health DisorderUnited States