Clinical trial NCT05857722: Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
Official title: Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotion Regulation
Mood Disorders
Keywords: Intervention
Implementation
Venezuelan migrants
Internally displaced population
Forced migration
Mental health
Emotion regulation
Lead sponsor: Boston College
Sponsor class: OTHER
Collaborators: name: Brown University
name: Universidad de Los Andes
First posted: 2023-05-15
Enrollment: 296
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Baseline
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: Immediately post-intervention
measure: Difficulties in Emotion Regulation Scale (DERS)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: Baseline
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: Immediately post-intervention
measure: World Health Organization Disability Assessment Schedule (WHODAS)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Immediately post-intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Baseline
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: Immediately post-intervention
measure: Generalized Anxiety Disorder Screener (GAD-7)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
timeFrame: Baseline
measure: Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
timeFrame: Immediately post-intervention
measure: Post-traumatic stress disorder Checklist-Civilian Version (PTSD CL)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: General Self-Efficacy Scale
timeFrame: Baseline
measure: General Self-Efficacy Scale
timeFrame: Immediately post-intervention
measure: General Self-Efficacy Scale
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
timeFrame: Baseline
measure: Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
timeFrame: Immediately post-intervention
measure: Demographic and Household Scale Intimate Partner Violence (DHS-IPV)
timeFrame: 6 month follow-up: up to 8 months post-baseline
measure: Labor market outcomes
timeFrame: Baseline
measure: Labor market outcomes
timeFrame: Immediately post-intervention
measure: Labor market outcomes
timeFrame: 6 month follow-up: up to 8 months post-baseline
Secondary outcomes:
measure: Family Care Indicators (FCI)
timeFrame: Baseline
measure: Family Care Indicators (FCI)
timeFrame: Immediately post-intervention
measure: Family Care Indicators (FCI)
timeFrame: 6 month follow-up: up to 8 months post-baseline
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Open recruitment
Study officials:
References: