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Clinical Trials/NCT06627764
NCT06627764
Recruiting
Not Applicable

SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Immigrant Families

Duke University2 sites in 1 country400 target enrollmentJune 30, 2025
InterventionsSER Familia

Overview

Phase
Not Applicable
Intervention
SER Familia
Conditions
Not specified
Sponsor
Duke University
Enrollment
400
Locations
2
Primary Endpoint
Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version
Status
Recruiting
Last Updated
23 days ago

Overview

Brief Summary

This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a family-based intervention. SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH). More specifically, investigators aim to: 1) Examine the efficacy of SER Familia to prevent or reduce the syndemic comprised of substance abuse, IPV, HIV risk, depression, and anxiety among Parents and Youth; and 2) Identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of SER Familia.

Registry
clinicaltrials.gov
Start Date
June 30, 2025
End Date
January 31, 2029
Last Updated
23 days ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Eligible participants must identify as Hispanic/Latino/a/x/e,
  • be a first generation immigrant parent or parental figure (Parent)
  • have a child (Youth) aged 12-17
  • speak English and/or Spanish

Exclusion Criteria

  • Families planning to move within two years will be excluded

Arms & Interventions

Familia SER (Salud, Estrés y Resilencia) Group

Participants will attend six intervention sessions.

Intervention: SER Familia

Control Group

Participants will not receive SER Familia sessions.

Outcomes

Primary Outcomes

Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version

Time Frame: From Enrollment to end of treatment at 6 weeks

The immigrant version of the HSI-2 includes 10 stress subscales. For each item, participants indicated whether they had experienced the stressor (Yes / No). If participants reported experiencing a stressor, then they rated how stressful the event was on a 5-point Likert scale (1= Not at all worried / tense; 2 = A little worried / tense; 3 = Moderately worried / tense; 4 = Very worried/ tense; 5 = Extremely worried/ tense). The total score ranges from 94 to 470, where a higher score indicates greater stress.

Change in Youth Acculturative stress as measured by the Hispanic Stress Inventory - Adolescent (HSI-A)

Time Frame: From Enrollment to end of treatment at 6 weeks

The HSI-A includes 8 stress subscales. For each item, participants indicated whether they had experienced the stressor (Yes / No). If participants reported experiencing a stressor, then they rated how stressful the event was on a 5-point Likert scale (1= Not at all worried / tense; 2 = A little worried / tense; 3 = Moderately worried / tense; 4 = Very worried/ tense; 5 = Extremely worried/ tense). The total score ranges from 72 to 360, where a higher score indicates greater stress.

Change in individual resilience as measured by the 25-item Resiliency Scale

Time Frame: From Enrollment to end of treatment at 6 weeks

The Resiliency Scale uses a 7-point Likert scale to assess how much a respondent agrees or disagrees with statements. The possible total score ranges from 25 to 175, with higher scores indicating greater resilience. Scores above 145 indicate high resilience, 121 to 145 indicate moderate resilience, and below 120 indicate low resilience.

Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health

Time Frame: From Enrollment to end of treatment at 6 weeks

The PROMIS Global Health score ranges from 10 to 50, where a higher score indicates better overall health.

Study Sites (2)

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