NCT05991739

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 (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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 15, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

9 months

First QC Date

August 7, 2023

Last Update Submit

July 10, 2024

Conditions

Keywords

immigrant familiesstress interventionstructural racismlatino

Outcome Measures

Primary Outcomes (3)

  • Hispanic Stress Inventory 2

    Self-reported (parent and youth) stress due to structural racism

    Baseline, 3 months, and 6 months

  • Perceived Stress Scale

    Self reported (parent and youth) daily stress

    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

    Baseline, 3 months, and 6 months

Secondary Outcomes (5)

  • Brief Coping Orientation to Problems Experienced Inventory

    Baseline, 3 months, and 6 months

  • Family Crisis Oriented Personal Evaluation Scales

    Baseline, 3 months, and 6 months

  • Parent-Adolescent Communication Scale

    Baseline, 3 months, and 6 months

  • General Self-Efficacy Scale

    Baseline, 3 months, and 6 months

  • Knowledge of Resources

    Baseline, 3 months, and 6 months

Other Outcomes (1)

  • Implementation Interview

    Post-intervention (Time 2 for the treatment arm and Time 3 for the waitlist-control arm)

Study Arms (2)

Treatment

EXPERIMENTAL

Participants in the treatment arm will begin the FIESTA intervention immediately (Time 1).

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).

Behavioral: Familias Inmigrantes Empoderándose contra eStrés Tomando Acción (FIESTA)

Interventions

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.

TreatmentWaitlist-Control

Eligibility Criteria

Age14 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Adults and youth unable to cognitively participate in the group or adults who are unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

RECRUITING

MeSH Terms

Conditions

Stress, PsychologicalSystemic Racism

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorRacismPrejudiceSocial BehaviorSocial Discrimination

Study Officials

  • Stephanie A Torres, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie A Torres, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2023

First Posted

August 15, 2023

Study Start

November 2, 2023

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations