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

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.

Study Overview

• Status: Completed
• Conditions: Mood Disorders; Emotion Regulation
• Intervention / Treatment: Behavioral: Jóvenes Capibara

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 Type: Interventional
• Enrollment (Actual): 296
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Open recruitment

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Entrepreneurship and Jóvenes Capibara group; 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.	Behavioral: Jóvenes Capibara; 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
Other: Control waitlist condition; 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.	Behavioral: Jóvenes Capibara; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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	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	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	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.	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.	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.	6 month follow-up: up to 8 months post-baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6 month follow-up: up to 8 months post-baseline

Collaborators and Investigators

• Sponsor: Boston College
• Collaborators: Brown University; Universidad de Los Andes

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 5, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Implementation; Intervention; Mental health; Emotion regulation; Venezuelan migrants; Internally displaced population; Forced migration
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders
• Other Study ID Numbers: 27332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No