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

NCT05857722 | Completed

• 1 other identifier: 27332
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Emotion Regulation; Mood Disorders

Keywords

Intervention; Implementation; Venezuelan migrants; Internally displaced population; Forced migration; Mental health; Emotion regulation

Outcome Measures

Primary Outcomes (24)

• 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 Outcomes (3)

• Family Care Indicators (FCI)

  Baseline

• Family Care Indicators (FCI)

  Immediately post-intervention

• Family Care Indicators (FCI)

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

Study Arms (2)

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.

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.

Behavioral: Jóvenes Capibara

Interventions

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.

Also known as: Youth Readiness Intervention

Control waitlist condition; Entrepreneurship and Jóvenes Capibara group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brown University: collaborator
• Boston College: lead
• Universidad de Los Andes: collaborator

Study Sites (1)

Open recruitment

Bogotá, Colombia

Location

Related Publications (1)

• 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.

  PMID: 40745658 DERIVED

MeSH Terms

Conditions

Emotional Regulation; Mood Disorders; Psychological Well-Being

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Mental Disorders; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 15, 2023
• Study Start: March 21, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: August 6, 2024

Record last verified: 2024-08

Locations

CO (1)