Emotion RegulationJCNCT05857722
Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
A study testing Jóvenes Capibara in people with Emotion Regulation and Mood Disorders, run by Boston College at 1 site in Colombia.
Trial summary
The goal of this randomized controlled trial is to test the effectiveness of an emotion regulation intervention called Jóvenes Capibara in a Venezuelan migrant and internally displaced population sample of youth between the ages of 18 through 30 delivered within a 10-day boot-camp entrepreneurship program. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotion Regulation, Mood Disorders
- What is being tested?
- Jóvenes Capibara
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 1 siteColombia
- Study dates
- 21 Mar 2023to 1 Dec 2023
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Youth aged 18-30
- Venezuelan migrant or Colombian who has been internally displaced or directly/indirectly impacted by internal conflict in Colombia
Who cannot join
- Current suicidality or homicidality
- Psychosis
- Serious medical condition, or severe cognitive impairment that would preclude ability to participate in study assessments and activities, as assessed via the MINI-SCID by a study psychologist.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this randomized controlled trial is to test the effectiveness of an emotion regulation intervention called Jóvenes Capibara in a Venezuelan migrant and internally displaced population sample of youth between the ages of 18 through 30 delivered within a 10-day boot-camp entrepreneurship program. The main questions it aims to answer are: (a) Is Jóvenes Capibara feasible and acceptable among internally displaced population and Venezuelan migrant youth aged 18-30 in Colombia?; (b) Is delivery of Jóvenes Capibara within entrepreneurship training feasible and acceptable among facilitators?; (c) Is Jóvenes Capibara associated with improved mental health, daily functioning, and labor market outcomes in Colombian and Venezuelan youth who receive the intervention compared with youth in the control group? Participants will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. Measures will be taken at baseline, post-intervention, and at 6-month post-intervention follow-up. The comparison group will receive the intervention one year after youth in the experimental condition. The researchers will compare the experimental group and the waitlist control group to determine the effects of Jóvenes Capibara on mental health, daily functioning, and labor market outcomes.
Read the detailed description
The investigators will recruit and enroll 120 male/120 female youth (N=240) aged 18-30 from several communities in Bogotá using stratified selection for gender balance; and then randomize youth to receive Jóvenes Capibara within entrepreneurship training (N=120) or to a waitlist condition (N=120). Waitlisted youth will be eligible to receive the intervention after 6-month follow-up data collection. A codified set of randomization rules will minimize contamination risks, and a computer-generated randomization allocation sequence will guide randomization procedures.
Measures, Data Points, and Data Analysis Strategy: The investigators will collect quantitative data on mental health and daily functioning at baseline, post-intervention, and 6-month follow-up. The investigators will collect qualitative and quantitative data at post-intervention from facilitators on implementation outcomes (feasibility, acceptability, adoption, appropriateness). The investigators will use the Difficulties in Emotion Regulation Scale (DERS), General Self-Efficacy Scale, WHO Disability Assessment Schedule (WHODAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screener (GAD-7), PTSD Checklist-Civilian Version (PCL-C), and the Demographic and Household Scale IPV items (DHS-IPV). The investigators will also assess labor market outcomes, including employment, hours worked, and income earned at each time point. A subset of youth (n=24) selected based on a multivariate sampling matrix will complete exit interviews to assess feasibility, acceptability and satisfaction with the intervention.
The investigators will use mixed linear effects modeling to investigate the clinical effectiveness of the Jóvenes Capibara on mental and behavioral health outcomes among youth. The investigators will compare Jóvenes Capibara participants to those in the control condition to assess whether there is significantly greater change in mental health, emotion regulation, daily functioning, and labor market outcomes over time among Jóvenes Capibara participants. The investigators will use mixed effects linear models to assess the impact of the intervention on quantitative mental health outcomes. These models will account for clustering of individual outcomes among lay health workers delivering the Jóvenes Capibara as well clustering of outcomes within individuals across time points. In cases where the outcome scale scores are skewed and violate the normality assumption for linear models, the investigators will use generalized linear models with a Poisson distribution. The investigators will include a time dummy variable to account for time effects and treatment by time interaction terms to test the impact of the treatment on outcomes at post-intervention and 6-month follow-up. All analyses will be conducted on an intent-to-treat basis.
Power considerations will assess our primary hypothesis -Jóvenes Capibara youth will report significantly greater mental health benefits than control youth. The investigators assume a standardized mean difference between intervention and control conditions of approximately 0.30-0.45 to determine Jóvenes Capibara effectiveness on youth mental health outcomes, which corresponds to the effect sizes observed in our prior studies. Assuming a standard alpha level of <0.05 with data from 2 time points with a moderate intra-class (within individual) correlation of approximately 0.5, and accounting for 20% attrition, this RCT has power of 0.80 to detect a standardized medium effect size of approximately 0.35.
- Conditions
- Emotion Regulation, Mood Disorders
- Being tested
- Jóvenes Capibara
- Keywords
- Intervention, Implementation, Venezuelan migrants, Internally displaced population, Forced migration, Mental health, Emotion regulation
- Medical subject headings
- Emotional Regulation, Mood Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jóvenes CapibaraBehavioural
Also called Youth Readiness Intervention
Jóvenes Capibara is a 10-session group intervention that was culturally adapted from the Youth Readiness Intervention, which was originally developed in Sierra Leone for conflict-affected youth. Jóvenes Capibara was adapted to the Colombian context using the ADAPT-ITT framework, which ensured that the intervention was relevant to the needs of Colombian and Venezuelan youth.
| Study group | Role | What they receive |
|---|---|---|
| Entrepreneurship and Jóvenes Capibara group | Experimental | Participants in the experimental arm will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. Receives: Behavioral: Jóvenes Capibara |
| Control waitlist condition | Other | Participants in the control waitlist condition will will be eligible to receive the intervention after 6-month follow-up data collection, which will take place approximately 10 to 12 months after the Entrepreneurship and Jóvenes Capibara group receives the intervention. Receives: Behavioral: Jóvenes Capibara |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotion Regulation Scale (DERS)
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
Measured: Baseline
Difficulties in Emotion Regulation Scale (DERS)
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
Measured: Immediately post-intervention
Difficulties in Emotion Regulation Scale (DERS)
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
Measured: 6 month follow-up: up to 8 months post-baseline
World Health Organization Disability Assessment Schedule (WHODAS)
36-item scale that measures self-rated disability using a 5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
Measured: Baseline
World Health Organization Disability Assessment Schedule (WHODAS)
36-item scale that measures self-rated disability using a 5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
Measured: Immediately post-intervention
World Health Organization Disability Assessment Schedule (WHODAS)
36-item scale that measures self-rated disability using a 1-5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
Measured: 6 month follow-up: up to 8 months post-baseline
Patient Health Questionnaire (PHQ-9)
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Measured: Baseline
Patient Health Questionnaire (PHQ-9)
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Measured: Immediately post-intervention
Patient Health Questionnaire (PHQ-9)
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Measured: 6 month follow-up: up to 8 months post-baseline
Generalized Anxiety Disorder Screener (GAD-7)
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Measured: Baseline
Generalized Anxiety Disorder Screener (GAD-7)
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Measured: Immediately post-intervention
Generalized Anxiety Disorder Screener (GAD-7)
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Measured: 6 month follow-up: up to 8 months post-baseline
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
Measured: Baseline
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
Measured: Immediately post-intervention
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
Measured: 6 month follow-up: up to 8 months post-baseline
General Self-Efficacy Scale
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
Measured: Baseline
General Self-Efficacy Scale
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
Measured: Immediately post-intervention
General Self-Efficacy Scale
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
Measured: 6 month follow-up: up to 8 months post-baseline
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Measured: Baseline
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Measured: Immediately post-intervention
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Measured: 6 month follow-up: up to 8 months post-baseline
Labor market outcomes
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
Measured: Baseline
Labor market outcomes
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
Measured: Immediately post-intervention
Labor market outcomes
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
Measured: 6 month follow-up: up to 8 months post-baseline
Secondary outcomes (3)
Family Care Indicators (FCI)
12-item questionnaire. 6 items are follow-up items to the stem question (even number questions). If the stem question is endorsed, then the follow-up question is asked. Stem question has two answers; Yes [1], No [0]. The follow-up questions ask who engaged the child on a certain activity (i.e., mother, father, other). Lower scores indicate worse child engagement outcomes.
Measured: Baseline
Family Care Indicators (FCI)
12-item questionnaire. 6 items are follow-up items to the stem question (even number questions). If the stem question is endorsed, then the follow-up question is asked. Stem question has two answers; Yes [1], No [0]. The follow-up questions ask who engaged the child on a certain activity (i.e., mother, father, other). Lower scores indicate worse child engagement outcomes.
Measured: Immediately post-intervention
Family Care Indicators (FCI)
12-item questionnaire. 6 items are follow-up items to the stem question (even number questions). If the stem question is endorsed, then the follow-up question is asked. Stem question has two answers; Yes [1], No [0]. The follow-up questions ask who engaged the child on a certain activity (i.e., mother, father, other). Lower scores indicate worse child engagement outcomes.
Measured: 6 month follow-up: up to 8 months post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start21 Mar 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotion RegulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will recruit and enroll 120 male/120 female youth (N=240) aged 18-30 from several communities in Bogotá using stratified selection for gender balance; and then randomize youth to receive Jóvenes Capibara within entrepreneurship training (N=120) or to a waitlist condition (N=120). Waitlisted youth will be eligible to receive the intervention after 6-month follow-up data collection.
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston College
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University, Universidad de los Andes, Chile
- Responsible party
- Principal investigator, Maria Pineros Leano, Boston College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857722
- Sponsor's protocol ID
- 27332
- Acronym
- JC
- Status last verified
- Aug 2024
- First submitted
- 21 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Desrosiers A, Pineros-Leano M, Saran I, Escobar C, Pineros-Leano N, Jimenez MP, Moya A, Betancourt TS. Integrating a culturally adapted mental health intervention within entrepreneurship training for displaced youth in Colombia: a pilot randomized controlled trial. Confl Health. 2025 Jul 31;19(1):54. doi: 10.1186/s13031-025-00675-z.
PubMed 40745658
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
- ClinicalTrials.gov ID
- NCT05857722
- Acronym / sponsor ID
- JC / 27332
- Conditions
- Emotion Regulation, Mood Disorders
- Keywords
- Intervention, Implementation, Venezuelan migrants, Internally displaced population, Forced migration, Mental health, Emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Boston CollegeUniversity, hospital or other
- Collaborators
- Brown University, Universidad de los Andes, Chile
- Study start
- 21 Mar 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 15 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to test the effectiveness of an emotion regulation intervention called Jóvenes Capibara in a Venezuelan migrant and internally displaced population sample of youth between the ages of 18 through 30 delivered within a 10-day boot-camp entrepreneurship program. The main questions it aims to answer are: (a) Is Jóvenes Capibara feasible and acceptable among internally displaced population and Venezuelan migrant youth aged 18-30 in Colombia?; (b) Is delivery of Jóvenes Capibara within entrepreneurship training feasible and acceptable among facilitators?; (c) Is Jóvenes Capibara associated with improved mental health, daily functioning, and labor market outcomes in Colombian and Venezuelan youth who receive the intervention compared with youth in the control group? Participants will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. Measures will be taken at baseline, post-intervention, and at 6-month post-intervention follow-up. The comparison group will receive the intervention one year after youth in the experimental condition. The researchers will compare the experimental group and the waitlist control group to determine the effects of Jóvenes Capibara on mental health, daily functioning, and labor market outcomes.
Detailed description
The investigators will recruit and enroll 120 male/120 female youth (N=240) aged 18-30 from several communities in Bogotá using stratified selection for gender balance; and then randomize youth to receive Jóvenes Capibara within entrepreneurship training (N=120) or to a waitlist condition (N=120). Waitlisted youth will be eligible to receive the intervention after 6-month follow-up data collection. A codified set of randomization rules will minimize contamination risks, and a computer-generated randomization allocation sequence will guide randomization procedures.
Measures, Data Points, and Data Analysis Strategy: The investigators will collect quantitative data on mental health and daily functioning at baseline, post-intervention, and 6-month follow-up. The investigators will collect qualitative and quantitative data at post-intervention from facilitators on implementation outcomes (feasibility, acceptability, adoption, appropriateness). The investigators will use the Difficulties in Emotion Regulation Scale (DERS), General Self-Efficacy Scale, WHO Disability Assessment Schedule (WHODAS), Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Screener (GAD-7), PTSD Checklist-Civilian Version (PCL-C), and the Demographic and Household Scale IPV items (DHS-IPV). The investigators will also assess labor market outcomes, including employment, hours worked, and income earned at each time point. A subset of youth (n=24) selected based on a multivariate sampling matrix will complete exit interviews to assess feasibility, acceptability and satisfaction with the intervention.
The investigators will use mixed linear effects modeling to investigate the clinical effectiveness of the Jóvenes Capibara on mental and behavioral health outcomes among youth. The investigators will compare Jóvenes Capibara participants to those in the control condition to assess whether there is significantly greater change in mental health, emotion regulation, daily functioning, and labor market outcomes over time among Jóvenes Capibara participants. The investigators will use mixed effects linear models to assess the impact of the intervention on quantitative mental health outcomes. These models will account for clustering of individual outcomes among lay health workers delivering the Jóvenes Capibara as well clustering of outcomes within individuals across time points. In cases where the outcome scale scores are skewed and violate the normality assumption for linear models, the investigators will use generalized linear models with a Poisson distribution. The investigators will include a time dummy variable to account for time effects and treatment by time interaction terms to test the impact of the treatment on outcomes at post-intervention and 6-month follow-up. All analyses will be conducted on an intent-to-treat basis.
Power considerations will assess our primary hypothesis -Jóvenes Capibara youth will report significantly greater mental health benefits than control youth. The investigators assume a standardized mean difference between intervention and control conditions of approximately 0.30-0.45 to determine Jóvenes Capibara effectiveness on youth mental health outcomes, which corresponds to the effect sizes observed in our prior studies. Assuming a standard alpha level of <0.05 with data from 2 time points with a moderate intra-class (within individual) correlation of approximately 0.5, and accounting for 20% attrition, this RCT has power of 0.80 to detect a standardized medium effect size of approximately 0.35.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators will recruit and enroll 120 male/120 female youth (N=240) aged 18-30 from several communities in Bogotá using stratified selection for gender balance; and then randomize youth to receive Jóvenes Capibara within entrepreneurship training (N=120) or to a waitlist condition (N=120). Waitlisted youth will be eligible to receive the intervention after 6-month follow-up data collection.
| Arm | Type | Receives |
|---|---|---|
| Entrepreneurship and Jóvenes Capibara group | Experimental | Behavioral: Jóvenes CapibaraParticipants in the experimental arm will receive a 10-day intervention, which consists of an entrepreneurship program, plus Jóvenes Capibara, an intervention that aims to improve emotion regulation and mental health symptoms among youth impacted by violence. |
| Control waitlist condition | Other | Behavioral: Jóvenes CapibaraParticipants in the control waitlist condition will will be eligible to receive the intervention after 6-month follow-up data collection, which will take place approximately 10 to 12 months after the Entrepreneurship and Jóvenes Capibara group receives the intervention. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Youth aged 18-30
- Venezuelan migrant or Colombian who has been internally displaced or directly/indirectly impacted by internal conflict in Colombia
Key exclusion criteria (3 listed)
- Current suicidality or homicidality
- Psychosis
- Serious medical condition, or severe cognitive impairment that would preclude ability to participate in study assessments and activities, as assessed via the MINI-SCID by a study psychologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Jóvenes CapibaraAlso: Youth Readiness InterventionJóvenes Capibara is a 10-session group intervention that was culturally adapted from the Youth Readiness Intervention, which was originally developed in Sierra Leone for conflict-affected youth. Jóvenes Capibara was adapted to the Colombian context using the ADAPT-ITT framework, which ensured that the intervention was relevant to the needs of Colombian and Venezuelan youth. | Behavioural | Control waitlist condition, Entrepreneurship and Jóvenes Capibara group |
Primary outcome
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Baseline
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Immediately post-intervention
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
Difficulties in Emotion Regulation Scale (DERS)
Time frame: 6 month follow-up: up to 8 months post-baseline
18-item scale that measures emotion regulation using a 1-5 Likert scale. Lower scores indicate worse emotion regulation.
World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: Baseline
36-item scale that measures self-rated disability using a 5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: Immediately post-intervention
36-item scale that measures self-rated disability using a 5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: 6 month follow-up: up to 8 months post-baseline
36-item scale that measures self-rated disability using a 1-5 point Likert scale ranging from 1 (none) to 5 (extremely or cannot do it). Higher scores indicate higher levels of disability.
Patient Health Questionnaire (PHQ-9)
Time frame: Baseline
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Patient Health Questionnaire (PHQ-9)
Time frame: Immediately post-intervention
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Patient Health Questionnaire (PHQ-9)
Time frame: 6 month follow-up: up to 8 months post-baseline
9-item depression scale. This scale uses a 0-3 Likert scale. Lower levels indicate fewer symptoms of depression.
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: Baseline
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: Immediately post-intervention
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Generalized Anxiety Disorder Screener (GAD-7)
Time frame: 6 month follow-up: up to 8 months post-baseline
7-item anxiety scale. This scale uses a 0-3 Likert scale, with 0 being "not at all", and 3 being "nearly every day". Lower levels indicate fewer symptoms of anxiety.
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
Time frame: Baseline
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
Time frame: Immediately post-intervention
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
Time frame: 6 month follow-up: up to 8 months post-baseline
17-item post-traumatic stress scale. This scale uses a 1-5 Likert scale, with 1 being "Not at all" and 5 being "Extremely". Lower scores indicate fewer symptoms of post-traumatic stress.
General Self-Efficacy Scale
Time frame: Baseline
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
General Self-Efficacy Scale
Time frame: Immediately post-intervention
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
General Self-Efficacy Scale
Time frame: 6 month follow-up: up to 8 months post-baseline
10-item self-efficacy scale. This scale uses a 1-4 Liker scale, with 1 being "Not at all true", and 4 being "Exactly true". Lower scores indicate lower levels of self-efficacy.
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
Time frame: Baseline
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
Time frame: Immediately post-intervention
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
Time frame: 6 month follow-up: up to 8 months post-baseline
19-36 item questionnaire. The number of items asked depends on the number of questions endorsed. The answers are Yes [1] or No [0]. The first 5 questions are asked to everyone and they do not have skip patterns. Questions 6-35 are asked and if the answer is yes, a follow-up question is asked; otherwise, the question follow-up question is skipped. Lower levels indicate lower levels of intimate partner violence
Labor market outcomes
Time frame: Baseline
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
Labor market outcomes
Time frame: Immediately post-intervention
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
Labor market outcomes
Time frame: 6 month follow-up: up to 8 months post-baseline
Labor market outcomes are measured using a validated scale developed in Colombia. It consists of 21 questions. Questions 1-4 are Yes [1], No [2] questions. If Yes is answered on these questions, then questions 5-19 are asked. Otherwise, questions 5-19 are skipped and asked questions 20 and 21. This questionnaire asks about type of employment, number of hours worked, number of days worked within the past month, occupation, and income.
3 secondary outcomes
Family Care Indicators (FCI)
Time frame: Baseline
Family Care Indicators (FCI)
Time frame: Immediately post-intervention
Family Care Indicators (FCI)
Time frame: 6 month follow-up: up to 8 months post-baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 40745658Desrosiers A, Pineros-Leano M, Saran I, Escobar C, Pineros-Leano N, Jimenez MP, Moya A, Betancourt TS. Integrating a culturally adapted mental health intervention within entrepreneurship training for displaced youth in Colombia: a pilot randomized controlled trial. Confl Health. 2025 Jul 31;19(1):54. doi: 10.1186/s13031-025-00675-z.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Jóvenes Capibara in people with Emotion Regulation and Mood Disorders, run by Boston College at 1 site in Colombia.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Difficulties in Emotion Regulation Scale (DERS) (time frame: Baseline). The study lists 24 primary outcomes in all. 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 NCT05857722, 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 6 Aug 2024.