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Recruiting NCT06627764

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

No phase Interventional Substance Abuse Intimate Partner Violence (IPV) HIV Infections Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SER Familia.
Who it may be relevant to
Registry conditions: Substance Abuse, Intimate Partner Violence (IPV), HIV Infections, Depression. Basic parameters: 12 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral SER Familia
    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).

Primary outcome measures

  • 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]
  • 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]
  • Change in individual resilience as measured by the 25-item Resiliency Scale [Time frame: From Enrollment to end of treatment at 6 weeks]
  • Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health [Time frame: From Enrollment to end of treatment at 6 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Duke School of Nursing — Durham

Identifiers

NCT: NCT06627764 · Pro00114672 · 1R01MD018920-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗