Stress, PsychologicalNCT05991739
Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families
A study testing Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA) in people with Stress, Psychological and Mental Health Wellness, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to evaluate a new, community-based, group intervention called FIESTA (Familias Inmigrantes Empoderándose contra eStrés Tomando Acción) to understand how well it helps Latinx immigrant families deal with the impact of stress due to structural racism. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Mental Health Wellness
- What is being tested?
- Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2023to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Caregiver/Parent
- Identification as a Latina immigrant woman over the age of 18 years old
- Parent or primary caregiver of a youth between the ages of 14-17
- Youth
- Identification as a Latinx adolescent between the ages of 14-17
- Child of a primary caregiver (mother) who identifies as a Latina immigrant
Who cannot join
- Adults and youth unable to cognitively participate in the group or adults who are unable to consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60607
Stephanie A Torres, PhD, 312-996-7327, satorres@uic.edu
About this study
Official title: Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families: Blending of Implementation Science and Community-Engaged Research
The purpose of this study is to evaluate a new, community-based, group intervention called FIESTA (Familias Inmigrantes Empoderándose contra eStrés Tomando Acción) to understand how well it helps Latinx immigrant families deal with the impact of stress due to structural racism. Structural racism is defined as the policies, practices, and norms that work together to limit equal opportunities for minority communities. For Latinx immigrant families, this can include fears of deportation, lack of bilingual providers, and discrimination. These experiences of structural racism can turn into stress, which impacts well-being and mental health.
Researchers will investigate if: 1) FIESTA lowers stress and mental health symptoms (anxiety/depression) and increases feelings of empowerment, improved knowledge of resources, better parent-youth relationship quality, and higher use of healthy coping skills; and 2) FIESTA is feasible (easy to carry out), acceptable (agreeable or satisfactory), and appropriate (relevant to the needs of Latinx families).
FIESTA is ten-sessions and will be led by two community health workers. Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in the initial study. This study will randomize parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. In other words, participants will be randomly assigned to one of two groups, the First Group, or the Second Group. The First Group will begin immediately, and the Second Group will begin after three months. Data will be collected at baseline and three- and six-month post-baseline.
Read the detailed description
The aim of the study is to pilot test a new, evidence-informed group intervention (FIESTA) among Latina immigrant mothers and youth (ages 14-17) and determine preliminary evidence as well as acceptability, appropriateness, and feasibility. FIESTA was developed in collaboration with a local community-based organization, the research team's established community partner.
Participants will be recruited through the research team's established community partnership. To participate in FIESTA, both the caregiver and child are required to participate. Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in the initial pilot study. This study will randomize parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months). Participants in the treatment arm will begin the intervention immediately (Time 1) and the waitlist-control arm will wait approximately three months for the intervention (Time 2). All participants will be reassessed at Time 2 (after 3-months) and again at Time 3 (after 6-months), once the wait-control group has completed the intervention. After the intervention (Time 2 for the treatment arm and Time 3 for the waitlist-control arm), participants will be asked a series of questions about the FIESTA intervention to assess for appropriateness, acceptability, and feasibility. All data collection will be completed by the research team.
Each FIESTA group will be led by two community health workers who will not be involved in the research and will not know who participates in the study. The community health workers will meet the following criteria: 1) have participated in a leadership role at the community-based organization or an affiliated organization for at least one year; 2) have experience facilitating at least one workshop; and 3) attend and participate in a three-day training for FIESTA led by the PI.
Each FIESTA session is two hours and will occur over ten weeks. FIESTA covers strategies related to individual stress management, family coping and communication, and community navigation. Throughout the sessions, there is an emphasis on sharing community-based resources if parents or youth are interested in obtaining future services. Each session will run parent and youth groups simultaneously, with a parent-youth activity built into each session. Parent and youth groups will be delivered separately to allow for a private space to discuss sensitive topics and practice skills. Material delivered to youth has been developmentally tailored. Session One provides participants with psychoeducation of stress, including the behavioral, emotional, and cognitive signs of stress, and focuses on recognizing stressors within Latinx communities. Session Two focuses on introducing the cognitive triangle and encourages participants to identify how their feelings, thoughts, and behaviors are connected. Participants will also learn evidence-based relaxation and mindfulness techniques that they will practice throughout the remainder of the sessions. Session Three teaches challenging negative thoughts and problem-solving techniques, using vignettes geared towards Latinx families (e.g., navigating language constraints at work). Session Four focuses on improving communication between parents and their children by teaching "I statements" and active listening through a series of role plays. Session Five is facilitated by an outside consultant recommended by the community partner and teaches about empowerment, the relationship between empowerment and self-esteem, and recognition of internal strengths and external support systems. Session Six focuses on principles developed from Know Your Rights trainings, including understanding rights when interacting with ICE and police and how to create a family emergency plan. Session Seven encourages participants to share their stress related to the Latinx experience, providing a safe space for participants to process their stress and collectively practice stress management skills learned in previous sessions. Session Eight aims to teach participants about advocacy, particularly advocacy in schools, and provides school- and community-based resources meant to help families navigate the school system. Session Nine focuses on financial wellness among immigrant communities, including creating budgets and learning about financial resources, including lending circles and financial aid. Session Ten is the culmination of FIESTA and allows participants to share their successes with the group, review skills, and discuss any linkages to resources. After Session 10, FIESTA will host a celebration where friends and family have a chance to share in the successes of participants.
- Conditions
- Stress, Psychological, Mental Health Wellness
- Being tested
- Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)
- Keywords
- immigrant families, stress intervention, structural racism, latino
- Medical subject headings
- Stress, Psychological, Systemic Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)Behavioural
FIESTA is a 10-session, group intervention led by community health workers that offers strategies related to individual stress management, family coping and communication, and community navigation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants in the treatment arm will begin the FIESTA intervention immediately (Time 1). Receives: Behavioral: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA) |
| Waitlist-Control | Other | Participants in the waitlist-control arm will wait approximately three months for the FIESTA intervention (Time 2). Receives: Behavioral: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hispanic Stress Inventory 2
Self-reported (parent and youth) stress due to structural racism
Measured: Baseline, 3 months, and 6 months
Perceived Stress Scale
Self reported (parent and youth) daily stress
Measured: Baseline, 3 months, and 6 months
Parent-Reported Outcome Measurement Information System Depression and Anxiety Short Form
Self reported (parent and youth) depression and anxiety symptoms
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (5)
Brief Coping Orientation to Problems Experienced Inventory
Self reported (parent and youth) individual coping
Measured: Baseline, 3 months, and 6 months
Family Crisis Oriented Personal Evaluation Scales
Self reported (parent and youth) family coping
Measured: Baseline, 3 months, and 6 months
Parent-Adolescent Communication Scale
Self reported (parent and youth) parent-child relationship quality
Measured: Baseline, 3 months, and 6 months
General Self-Efficacy Scale
Self reported (parent and youth) empowerment
Measured: Baseline, 3 months, and 6 months
Knowledge of Resources
Self reported (parent and youth) knowledge of resources in the community
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start2 Nov 2023
- Primary completionAug 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will randomize 35 parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months).
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- The Resurrection Project
- Responsible party
- Sponsor
- Investigators
- Stephanie A Torres, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991739
- Sponsor's protocol ID
- 2022-0108
- Other IDs
- CTSA UL1TR002003
- Status last verified
- Jul 2024
- First submitted
- 7 Aug 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families: Blending of Implementation Science and Community-Engaged Research
- ClinicalTrials.gov ID
- NCT05991739
- Acronym / sponsor ID
- 2022-0108
- Conditions
- Stress, Psychological, Mental Health Wellness
- Keywords
- immigrant families, stress intervention, structural racism, latino
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- The Resurrection Project
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate a new, community-based, group intervention called FIESTA (Familias Inmigrantes Empoderándose contra eStrés Tomando Acción) to understand how well it helps Latinx immigrant families deal with the impact of stress due to structural racism. Structural racism is defined as the policies, practices, and norms that work together to limit equal opportunities for minority communities. For Latinx immigrant families, this can include fears of deportation, lack of bilingual providers, and discrimination. These experiences of structural racism can turn into stress, which impacts well-being and mental health.
Researchers will investigate if: 1) FIESTA lowers stress and mental health symptoms (anxiety/depression) and increases feelings of empowerment, improved knowledge of resources, better parent-youth relationship quality, and higher use of healthy coping skills; and 2) FIESTA is feasible (easy to carry out), acceptable (agreeable or satisfactory), and appropriate (relevant to the needs of Latinx families).
FIESTA is ten-sessions and will be led by two community health workers. Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in the initial study. This study will randomize parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. In other words, participants will be randomly assigned to one of two groups, the First Group, or the Second Group. The First Group will begin immediately, and the Second Group will begin after three months. Data will be collected at baseline and three- and six-month post-baseline.
Detailed description
The aim of the study is to pilot test a new, evidence-informed group intervention (FIESTA) among Latina immigrant mothers and youth (ages 14-17) and determine preliminary evidence as well as acceptability, appropriateness, and feasibility. FIESTA was developed in collaboration with a local community-based organization, the research team's established community partner.
Participants will be recruited through the research team's established community partnership. To participate in FIESTA, both the caregiver and child are required to participate. Researchers will enroll 35 parent-adolescent dyads (35 study-eligible parents and 35 study-eligible youth) in the initial pilot study. This study will randomize parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months). Participants in the treatment arm will begin the intervention immediately (Time 1) and the waitlist-control arm will wait approximately three months for the intervention (Time 2). All participants will be reassessed at Time 2 (after 3-months) and again at Time 3 (after 6-months), once the wait-control group has completed the intervention. After the intervention (Time 2 for the treatment arm and Time 3 for the waitlist-control arm), participants will be asked a series of questions about the FIESTA intervention to assess for appropriateness, acceptability, and feasibility. All data collection will be completed by the research team.
Each FIESTA group will be led by two community health workers who will not be involved in the research and will not know who participates in the study. The community health workers will meet the following criteria: 1) have participated in a leadership role at the community-based organization or an affiliated organization for at least one year; 2) have experience facilitating at least one workshop; and 3) attend and participate in a three-day training for FIESTA led by the PI.
Each FIESTA session is two hours and will occur over ten weeks. FIESTA covers strategies related to individual stress management, family coping and communication, and community navigation. Throughout the sessions, there is an emphasis on sharing community-based resources if parents or youth are interested in obtaining future services. Each session will run parent and youth groups simultaneously, with a parent-youth activity built into each session. Parent and youth groups will be delivered separately to allow for a private space to discuss sensitive topics and practice skills. Material delivered to youth has been developmentally tailored. Session One provides participants with psychoeducation of stress, including the behavioral, emotional, and cognitive signs of stress, and focuses on recognizing stressors within Latinx communities. Session Two focuses on introducing the cognitive triangle and encourages participants to identify how their feelings, thoughts, and behaviors are connected. Participants will also learn evidence-based relaxation and mindfulness techniques that they will practice throughout the remainder of the sessions. Session Three teaches challenging negative thoughts and problem-solving techniques, using vignettes geared towards Latinx families (e.g., navigating language constraints at work). Session Four focuses on improving communication between parents and their children by teaching "I statements" and active listening through a series of role plays. Session Five is facilitated by an outside consultant recommended by the community partner and teaches about empowerment, the relationship between empowerment and self-esteem, and recognition of internal strengths and external support systems. Session Six focuses on principles developed from Know Your Rights trainings, including understanding rights when interacting with ICE and police and how to create a family emergency plan. Session Seven encourages participants to share their stress related to the Latinx experience, providing a safe space for participants to process their stress and collectively practice stress management skills learned in previous sessions. Session Eight aims to teach participants about advocacy, particularly advocacy in schools, and provides school- and community-based resources meant to help families navigate the school system. Session Nine focuses on financial wellness among immigrant communities, including creating budgets and learning about financial resources, including lending circles and financial aid. Session Ten is the culmination of FIESTA and allows participants to share their successes with the group, review skills, and discuss any linkages to resources. After Session 10, FIESTA will host a celebration where friends and family have a chance to share in the successes of participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will randomize 35 parent-youth dyads to the treatment arm or waitlist-control arm using block randomization. Each group will have 7-9 dyads, with two groups running simultaneously (treatment arm) and the remaining two groups running in three months (waitlist-control arm). After all participants are enrolled, families will be randomly selected to participate in either the treatment arm (immediate start) or waitlist-control arm (delayed start after 3 months).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)Participants in the treatment arm will begin the FIESTA intervention immediately (Time 1). |
| Waitlist-Control | Other | Behavioral: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)Participants in the waitlist-control arm will wait approximately three months for the FIESTA intervention (Time 2). |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Caregiver/Parent
- Identification as a Latina immigrant woman over the age of 18 years old
- Parent or primary caregiver of a youth between the ages of 14-17
- Youth
- Identification as a Latinx adolescent between the ages of 14-17
Key exclusion criteria (1 listed)
- Adults and youth unable to cognitively participate in the group or adults who are unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)FIESTA is a 10-session, group intervention led by community health workers that offers strategies related to individual stress management, family coping and communication, and community navigation. | Behavioural | Treatment, Waitlist-Control |
Primary outcome
Hispanic Stress Inventory 2
Time frame: Baseline, 3 months, and 6 months
Self-reported (parent and youth) stress due to structural racism
Perceived Stress Scale
Time frame: Baseline, 3 months, and 6 months
Self reported (parent and youth) daily stress
Parent-Reported Outcome Measurement Information System Depression and Anxiety Short Form
Time frame: Baseline, 3 months, and 6 months
Self reported (parent and youth) depression and anxiety symptoms
5 secondary outcomes
Brief Coping Orientation to Problems Experienced Inventory
Time frame: Baseline, 3 months, and 6 months
Family Crisis Oriented Personal Evaluation Scales
Time frame: Baseline, 3 months, and 6 months
Parent-Adolescent Communication Scale
Time frame: Baseline, 3 months, and 6 months
General Self-Efficacy Scale
Time frame: Baseline, 3 months, and 6 months
Knowledge of Resources
Time frame: Baseline, 3 months, and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Torres, PhD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA) in people with Stress, Psychological and Mental Health Wellness, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stephanie A Torres, PhD (312-996-7327, satorres@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hispanic Stress Inventory 2 (time frame: Baseline, 3 months, and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.