The Impact of Digital Mental Health Technology on Mental Health, Education, and Economic Outlook of Young Adults

Last registered on February 05, 2025

Pre-Trial

Trial Information

General Information

Title
The Impact of Digital Mental Health Technology on Mental Health, Education, and Economic Outlook of Young Adults
RCT ID
AEARCTR-0015221
Initial registration date
January 31, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
February 05, 2025, 8:31 AM EST

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

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Primary Investigator

Affiliation
University of Lausanne

Other Primary Investigator(s)

PI Affiliation
Fundación Santa Fe de Bogotá
PI Affiliation
Fundación Santa Fe de Bogotá
PI Affiliation
Prosperidad Social
PI Affiliation
University of Basel

Additional Trial Information

Status
In development
Start date
2025-02-03
End date
2026-12-31
Secondary IDs
ISRCT 46680
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Mental health challenges can exacerbate poverty by limiting educational attainment, reducing social mobility, and hindering economic advancement. Globally, increasing higher education participation among low-income students is a key policy priority to combat poverty. While efforts typically target financial or access barriers, the critical role of mental health is often overlooked. Digital mental health technologies have emerged as scalable and potentially cost-effective solutions to bridge the mental health care gap, particularly for vulnerable young adults. While evidence suggests these interventions can improve mental health in the short term, existing studies are often small-scale, underpowered, and predominantly from high income countries. This study examines the effects of digital mental health technology on the mental health, educational, and economic outcomes of low-income students in Colombia. The trial is embedded within the Renta Joven program, a nationwide conditional cash transfer initiative supporting low-income young people to access, persist in, and graduate from higher education.
External Link(s)

Registration Citation

Citation
Escobar Lux, Martha et al. 2025. "The Impact of Digital Mental Health Technology on Mental Health, Education, and Economic Outlook of Young Adults." AEA RCT Registry. February 05. https://doi.org/10.1257/rct.15221-1.0
Sponsors & Partners

Partner

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Experimental Details

Interventions

Intervention(s)
The Youth Well-being Digital platform
Treatment groups will have access to a 10-week, digital, transdiagnostic mental health intervention grounded in cognitive behavioural therapy. The transdiagnostic approach addresses multiple mental health problems simultaneously. The Youth Well-being platform, co-designed with young beneficiaries and staff of the Renta Joven program, comprises six modules: motivational interviewing, behavioural activation, problem-solving, interpersonal effectiveness, sleep strategies, and PTSD symptom management. Additionally, an emotional regulation toolbox is available for flexible use as needed. All modules and tools rely on and are inspired by components of protocols tested in comparable populations.

Peer support
Peer support is aimed to clarify any questions regarding the platform’s tools and to motivate participants to remain engaged with the platform. Peers are trained to provide relatable guidance and emotional encouragement with the aim to enhance user engagement, help participants navigate the resources available in the platform, and ensure sustainability of the intervention. Peers will have contact with participants through personalized messages on the platform.
Intervention Start Date
2025-03-24
Intervention End Date
2025-06-01

Primary Outcomes

Primary Outcomes (end points)
This study focuses on two primary outcomes: mental health and education. Specific measures are as follows:
- Enrolment continuity, measured through the survey by assessing whether participants interrupted their program or dropped out, at baseline, 3, 6 and 9 months.
- Academic performance, measured based on participants’ grade point average (GPA) assessed through survey questions at baseline, 3, 6 and 9 months, complemented with government administrative data
- Mental health, measured using a PHQ-ADS index, a composite measure of depression and anxiety derived from the summed scores of the PHQ-9 and GAD-7 scales, at baseline, 3, 6 and 9 months;
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
• Employment outlook, measured by questions about aspirations and expectations on their employment and earning six months after graduation, assessed at baseline, 3 and 6 months
• Education aspirations and expectations, measured through questions about the extent to which they expect to continue and complete their study programme, and aspirations about their studies, assessed at baseline, 3 and 6 months
• Future orientation, comprising measures of: a) Patience, assessed through a 10-point Likert scale asking, “Compared to others, do you consider yourself a person willing to give up something today in order to benefit from it in the future?”; b) time discounting, measured through a series of two hypothetical binary choices between immediate and delayed financial rewards; c) self-Control, measured by the BSCS scale, a short 13-item self-report format measure of the general self-control construct; assessed at baseline, 3 and 6 months
• Study efforts: measured by questions about hours of self-study and engagement with study programme, at baseline, 3 and 6 months
• Courses completion, measured by questions on how many courses or modules they took in the prior semester, how many they expect to take, whether failing courses and how many, at baseline, 3 and 6 months
• Work and income, measured by questions about work (for all participants) and income (only for participants that completed their studies) during the last academic period, assessed at baseline, 3, 6 and 9 months
• Additional educational and employment outcomes from administrative data, particularly retention and continuity with study programme and compliance with Renta Joven conditions, as well as earnings from formal employment.
• Standardized scores for depression (PHQ-9), anxiety (GAD-7), and PTSD (PC-PTSD-5)
• Changes in clinical thresholds for depressive symptoms (measured with the PHQ-9), anxiety symptoms (measured with the GAD-7), and PTSD symptoms (measured with the PC-PTSD-5), at baseline, 3, 6 and 9 months
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Recruitment of participants is through the the Youth Income (Renta Joven) scheme, a government nationwide program that provides regular conditional cash-transfers to university and technical education students from low-income backgrounds. The trial takes place in close collaboration with the Administrative Department for Social Prosperity, the national government agency responsible for the Renta Joven programme.

Comparison groups are as follows:
1) Treatment group 1 will have access to the Youth Well-being digital mental health platform;
2) Treatment group 2 will have access to the youth Well-being digital mental health platform plus peer support;
3) The control group will receive general information about standard care.

Our main analysis will compare the pooled treatment groups (comprising both, Youth Well-being platform-only and platform-plus-peer) with the control group across all severity groups to maximize statistical power.

Procedure and assessment
Participants will go through the following procedure and assessment:
1) Screening survey: All eligible Renta Joven participants will be invited to complete a screening survey to assess consent, ability and means to participate in the study.
2) Baseline survey: Participants who meet eligibility criteria, consent to the study and complete the screening survey will be invited to take part in the baseline survey, which assesses a range of variables including mental health symptoms with three internationally recognized standard scales, all of which have been validated in Colombia: The Patient Health Questionnaire-9 (PHQ-9), designed to measure depressive symptoms; the Generalized Anxiety Disorder-7 (GAD-7), which evaluates symptoms of anxiety; and the Primary Care Posttraumatic Stress Disorder (PTSD) for DSM-5 (PC-PTSD-5), which assesses symptoms of PTSD. Participants will be classified into mild, moderate or severe levels of symptoms based on routinely used categorizations for each scale. Asymptomatic participants will be excluded.
3) Exclusion of participants at acute risk of suicide: Participants identified as having a risk of suicide and requiring emergency treatment will be excluded from the intervention and directed to a safety protocol and local services.
4) Randomization: Participants will be randomly allocated to the control (50%) or treatment group (50%). Stratified randomization by overall severity level (mild, moderate, severe) will be carried out using STATA. Fifty percent of participants within each severity group will be randomly allocated to the control group (usual care) and fifty percent to the treatment group (digital platform), with comparisons between these groups used to test our primary hypotheses. Participants with mild symptoms in the treatment group will access the Youth Well-being platform. Those in the treatment group with moderate or severe symptoms will be further randomized into two equal subgroups: 50% to platform-only and 50% to platform-plus-peer support.
5) Follow-up Assessments: We will conduct three follow-up surveys of effectiveness and implementation outcomes at 3, 6 and 9 months after the intervention begins. Data on user engagement will also be routinely collected automatically through the Youth well-being digital platform. For participants who consent, government administrative data will also be used to assess educational and employment outcomes.
Experimental Design Details
Not available
Randomization Method
Participants will be randomly allocated to the control (50%) or treatment group (50%). Stratified randomization by overall severity level (mild, moderate, severe) will be carried out using stata. Fifty percent of participants within each severity group will be randomly allocated to the control group (usual care) and fifty percent to the treatment group (digital platform), with comparisons between these groups used to test our primary hypotheses. Participants with mild symptoms in the treatment group will access the Youth Well-being platform. Those in the treatment group with moderate or severe symptoms will be further randomized into two equal subgroups: 50% to platform-only and 50% to platform-plus-peer support.
Randomization Unit
Participants will be randomized at the individual level stratifying by overall severity severity of depression, anxiety and PTSD symptoms (mild, moderate or severe) as measured in the baseline survey.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
3 clusters: mild, moderate and severe levels of mental health symptoms
Sample size: planned number of observations
We are aiming to recruit 11,250 Renta Joven beneficiaries, although recruitment numbers will vary depending on response rate
Sample size (or number of clusters) by treatment arms
• Mild mental health symptoms (2812 individuals): 1406 in the control group and 1406 in the treatment group (platform)
• Moderate mental health symptoms (3375 individuals): 1687 in the control group, 1688 in the treatment group with 844 with access to the platform and 844 with access to the platform-plus-peer
• Severe mental health symptoms (5063 individuals): 2531 in the control group, 2532 in the treatment group with 1266 with access to the platform and 1266 with access to the platform-plus-peer
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Comité Corporativo de Ética de Investigación de la Fundacion Santa Fe de Bogota
IRB Approval Date
2024-07-29
IRB Approval Number
CCEI-16632-2024
IRB Name
Comité Corporativo de Ética de Investigación de la Fundacion Santa Fe de Bogota
IRB Approval Date
2025-01-27
IRB Approval Number
CCEI-17269-2025