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

April 7, 2026 updated by: Duke University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Familia SER (Salud, Estrés y Resilencia) Group
Participants will attend six intervention sessions.
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).
No Intervention: Control Group
Participants will not receive SER Familia sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
The PROMIS Global Health score ranges from 10 to 50, where a higher score indicates better overall health.
From Enrollment to end of treatment at 6 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceptions of the impact of SER Familia on Parents and Youth as measured by semi-structured interviews
Time Frame: From end of treatment at 6 weeks to the end of year two
Exemplar questions include: 1) How did the program influence your resilience against family stress?; 2) What impact did the program have on your relationship with your parents/children?; 3) How did your parents/child's behaviors change throughout the program and after?; 4) How did those changes influence you and your family?; 5) What new connections or resources were you able to access during the program?; 6) What impact did this have on you, your family, or your community? 7) How did the impact of SER Familia influence the family over the past year (i.e., for 12-month follow-up)?
From end of treatment at 6 weeks to the end of year two

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Minority Health and Health Disparities (NIMHD)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00114672
  • 1R01MD018920-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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