Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05991739
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-08-07
Brief Title:
Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families Blending of Implementation Science and Community-Engaged Research
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief 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 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 anxietydepression 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
Researchers will investigate if 1 FIESTA lowers stress and mental health symptoms anxietydepression 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 teams established community partner
Participants will be recruited through the research teams 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 eg 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
Participants will be recruited through the research teams 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 eg 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 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CTSA UL1TR002003 | OTHER_GRANT | UIC Center for Clinical and Translational Science | None |