Recruiting

SER Familia

Sponsor:

Duke University

Code:

NCT06627764

Conditions

Substance Abuse

Intimate Partner Violence (IPV)

HIV Infections

Depression

Anxiety

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

Interventions

SER Familia

Study Details

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.

Conditions

Substance Abuse

Intimate Partner Violence (IPV)

HIV Infections

Depression

Anxiety

Study ID

NCT06627764

Start date

Jun 30, 2025

Status verified date

Apr, 2026

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Familia SER (Salud, Estrés y Resilencia) Group

Participants will attend six intervention sessions.

no intervention: Control Group

Participants will not receive SER Familia sessions.

Interventions

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Duke School of Nursing

Recruiting

Durham, North Carolina, United States, 27707

Contacts

More Information

Sponsor

Duke University

Last update posted

Apr 9, 2026

Last verified

Apr, 2026

Keywords

  • Family
  • Stress
  • Resilience

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2026-04-09.