Decision Making, Empowerment, Gender Based Violence Knowledge and Perceived Risk, Mental Health Issue, Refugee Self-reliance
Conditions
Brief summary
As of August 2021, Colombia hosts the vast majority of Venezuelan refugees and migrants (UNHCR, 2022). For vulnerable refugees and migrants in Colombia, and especially for women, gender-based violence (GBV) is present during transit and continues in their new homes where xenophobia, lack of accessible and adequate services, lack of safe economic opportunities, and lack of information on access to services, further increase risk. Lack of livelihood opportunities also affect vulnerable refugees and migrants, especially women, with barriers to employment including lack of information; precarious working conditions with lower payments and longer working days with increasing risks of labor exploitation; xenophobia and discrimination; limited access to formal labor markets; lack of access to financial services, among others. To address these issues, the investigators are conducting a pilot randomized-controlled trial (RCT) of HIAS' Entrepreneurship School with Gender Lens (ESGL), a methodology that targets GBV survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. The pilot RCT will be conducted within three cities in Colombia; approximately 80 eligible participants will be enrolled in each city and randomized to a treatment or control arm. Survey questionnaires will be administered to participants at baseline, eight months following baseline (endline), and 3-4 months after endline. Outcomes of interest include household self-reliance, mental health, empowerment, decision-making, and GBV risk and knowledge.
Interventions
BEHAVIORALEntrepreneurship School with Gender Lens
The Entrepreneurship School with Gender Lens (ESGL) is an approach that targets gender based violence survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. Participants will go through a general business curriculum, work on business plans and learn gender issues and ways to mitigate GBV risks. Upon training completion, participants are eligible to pitch their business idea to a panel of experts and receive $800 of seed capital. They will also receive follow-up business advisory support for at least six months, focusing on access to markets and finance and building support networks, in order to continue building self-reliance. The ESGL will also include a mental health and psychosocial support module.
Sponsors
Universidad de Los Andes
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Woman * At least 18 years of age * At risk of gender based violence (GBV) or ever experienced GBV * Have a migratory permit (for migrants/refugees) * Colombian or Venezuelan, living in Colombia for at least six months * Hold an entrepreneur profile registered with HIAS (the implementing partner).
Exclusion criteria
* Man or does not self identify as a woman * Less than 18 years old * Not at risk of GBV and never experienced GBV * Does not have a migratory permit * Not Colombian or Venezuelan * Living in Colombia for less than six months * No entrepreneur profile registered with HIAS (the implementing partner).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reliance Index From Baseline to Endline | Past three months | The Self-Reliance Index (SRI) is a measure of refugee self-reliance, created by the Refugee Self-Reliance Initiative. The final score is calculated using 12 domains of self-reliance, including the health-related domains of healthcare access and health status. SRI scores may assume a value from 1 to 5, with 5 indicating greater self-reliance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline | Past two weeks | The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. The score may assume a value from 0 to 27, with higher scores signaling greater depressive symptomology. |
| Change in Brief Scale of Resilient Strategies From Baseline to Endline | Last three months | The BriefScale of Resilient Strategies is a 4-item measure of resilience. The score may assume a value from 4 to 20, with higher scores signaling greater resilience. |
Countries
Colombia
Participant flow
Recruitment details
Participants were identified by HIAS through existing databases, external referrals from other organizations in the field and open calls. Potential participants were then prescreened, screened, and enrolled in the study based on a set of criteria from March 11th to 21st, 2024.
Pre-assignment details
Of 286 individuals screened, 253 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Entrepreneurship School with Gender Lens: The Entrepreneurship School with Gender Lens (ESGL) is an approach that targets gender based violence survivors and women at-risk to help them develop business ideas, access needed support for the prevention of and response to GBV, exploitation and trafficking, and improve participants' overall self-reliance. Participants will go through a general business curriculum, work on business plans and learn gender issues and ways to mitigate GBV risks. Upon training completion, participants are eligible to pitch their business idea to a panel of experts and receive $800 of seed capital. They will also receive follow-up business advisory support for at least six months, focusing on access to markets and finance and building support networks, in order to continue building self-reliance.
The ESGL also includes a mental health and psychosocial support module. | 175 |
| Control Group Does not receive the Entrepreneurship School with Gender Lens intervention the Entrepreneurship School with Gender Lens intervention | 78 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 29 | 13 |
Baseline characteristics
| Characteristic | Control Group | Total | Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 8 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 76 Participants | 245 Participants | 169 Participants |
| Age, Continuous | 39.04 years STANDARD_DEVIATION 12.12 | 39.36 years STANDARD_DEVIATION 11.67 | 39.50 years STANDARD_DEVIATION 11.49 |
| Brief Resilient Coping Scale | 16.85 units on a scale STANDARD_DEVIATION 1.41 | 16.85 units on a scale STANDARD_DEVIATION 1.97 | 16.85 units on a scale STANDARD_DEVIATION 2.18 |
| Completed primary school | 60 Participants | 183 Participants | 123 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 78 Participants | 253 Participants | 175 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household size | 4.18 people STANDARD_DEVIATION 1.79 | 4.09 people STANDARD_DEVIATION 1.66 | 4.05 people STANDARD_DEVIATION 1.61 |
| Nationality Colombian | 21 Participants | 72 Participants | 51 Participants |
| Nationality Venezuelan | 57 Participants | 181 Participants | 124 Participants |
| PHQ-9 | 9.01 units on a scale STANDARD_DEVIATION 4.82 | 8.08 units on a scale STANDARD_DEVIATION 5.15 | 7.66 units on a scale STANDARD_DEVIATION 5.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 78 Participants | 253 Participants | 175 Participants |
| Region of Enrollment Colombia | 78 participants | 253 participants | 175 participants |
| Self-Reliance Index | 3.27 units on a scale STANDARD_DEVIATION 0.5 | 3.27 units on a scale STANDARD_DEVIATION 0.54 | 3.27 units on a scale STANDARD_DEVIATION 0.56 |
| Sex: Female, Male Female | 78 Participants | 253 Participants | 175 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 0 / 78 |
| other Total, other adverse events | 0 / 175 | 0 / 78 |
| serious Total, serious adverse events | 0 / 175 | 0 / 78 |
Outcome results
Primary
Change in Self-reliance Index From Baseline to Endline
The Self-Reliance Index (SRI) is a measure of refugee self-reliance, created by the Refugee Self-Reliance Initiative. The final score is calculated using 12 domains of self-reliance, including the health-related domains of healthcare access and health status. SRI scores may assume a value from 1 to 5, with 5 indicating greater self-reliance.
Time frame: Past three months
Population: The sample that was measured at both baseline and endline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Self-reliance Index From Baseline to Endline | -0.03 score on a scale | Standard Deviation 0.64 |
| Control Group | Change in Self-reliance Index From Baseline to Endline | -0.21 score on a scale | Standard Deviation 0.66 |
Secondary
Change in Brief Scale of Resilient Strategies From Baseline to Endline
The BriefScale of Resilient Strategies is a 4-item measure of resilience. The score may assume a value from 4 to 20, with higher scores signaling greater resilience.
Time frame: Last three months
Population: Participants who were measured at baseline and endline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Brief Scale of Resilient Strategies From Baseline to Endline | 1.10 score on a scale | Standard Deviation 3.35 |
| Control Group | Change in Brief Scale of Resilient Strategies From Baseline to Endline | 0.43 score on a scale | Standard Deviation 3.66 |
Secondary
Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline
The Patient Health Questionnaire (PHQ-9) is a 9-item measure of depression. The score may assume a value from 0 to 27, with higher scores signaling greater depressive symptomology.
Time frame: Past two weeks
Population: Participants measured at baseline and endline.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline | -0.93 score on a scale | Standard Deviation 5.21 |
| Control Group | Change in Patient Health Questionnaire (PHQ-9) Score From Baseline to Endline | -1.49 score on a scale | Standard Deviation 5.71 |