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NCT Number: NCT06627764

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

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.

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Key information

Conditions

Substance Abuse Anxiety Anxiety Disorders Behavior Behavioral Symptoms Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Depression Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Intimate Partner Violence (IPV) Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

12 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SER Familia

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other outcomes

  1. 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)?

Study contacts

Contact information is provided by the study sponsor or research team.

Norma Garcia-Ortiz, BS

CONTACT

[email protected]

9196849331

Rosa Gonzalez-Guarda, PhD

CONTACT

[email protected]

9196132634

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Acronym: SER Familia

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 4, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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