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Completed

NCT Number: NCT05857722

Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement

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.

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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Mental Disorders Mood Disorders Personal Satisfaction Psychological Well-Being Self-Control Social Behavior

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Open recruitment

Bogotá, Colombia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Youth aged 18-30
  • Venezuelan migrant or Colombian who has been internally displaced or directly/indirectly impacted by internal conflict in Colombia

Exclusion criteria

  • 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.

Treatment and study plan

Jóvenes Capibara

Behavioral

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.

Other names: Youth Readiness Intervention

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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

  21. 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

  22. 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.

  23. 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.

  24. 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.

Secondary outcomes

  1. Family Care Indicators (FCI)

    Time frame: Baseline

    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.

  2. Family Care Indicators (FCI)

    Time frame: Immediately post-intervention

    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.

  3. Family Care Indicators (FCI)

    Time frame: 6 month follow-up: up to 8 months post-baseline

    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.

Sponsors and collaborators

Lead sponsor

Boston College

Other

Collaborators

  • Brown University
  • Universidad de Los Andes

Registry information

Acronym: JC

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 15, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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