NCT06627764

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
34mo left

Started Jun 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Jun 2025Jan 2029

First Submitted

Initial submission to the registry

October 3, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

June 30, 2025

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

October 3, 2024

Last Update Submit

April 7, 2026

Conditions

Keywords

FamilyStressResilience

Outcome Measures

Primary Outcomes (4)

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

    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)

    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

    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

    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 Outcomes (1)

  • Perceptions of the impact of SER Familia on Parents and Youth as measured by semi-structured interviews

    From end of treatment at 6 weeks to the end of year two

Study Arms (2)

Familia SER (Salud, Estrés y Resilencia) Group

EXPERIMENTAL

Participants will attend six intervention sessions.

Behavioral: SER Familia

Control Group

NO INTERVENTION

Participants will not receive SER Familia sessions.

Interventions

SER FamiliaBEHAVIORAL

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).

Familia SER (Salud, Estrés y Resilencia) Group

Eligibility Criteria

Age12 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Families planning to move within two years will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke School of Nursing

Durham, North Carolina, 27707, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related DisordersHIV InfectionsDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesBehavioral SymptomsBehavior

Central Study Contacts

Rosa Gonzalez-Guarda, PhD

CONTACT

Norma Garcia-Ortiz, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 4, 2024

Study Start

June 30, 2025

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

January 31, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations