Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857722
Status:
COMPLETED
Last Update Posted:
2023-05-15
First Post:
2023-04-21
Brief Title:
Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
Sponsor:
Boston College
Organization:
Boston College
Study Overview
Official Title:
Improving Mental Health Among Colombian and Venezuelan Youth Affected by Forced Displacement
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
JC
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 male120 female youth N240 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 N120 or to a waitlist condition N120 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 n24 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 030-045 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 005 with data from 2 time points with a moderate intra-class within individual correlation of approximately 05 and accounting for 20 attrition this RCT has power of 080 to detect a standardized medium effect size of approximately 035
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 n24 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 030-045 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 005 with data from 2 time points with a moderate intra-class within individual correlation of approximately 05 and accounting for 20 attrition this RCT has power of 080 to detect a standardized medium effect size of approximately 035
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None