SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Immigrant Families
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-100
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Families planning to move within two years will be excluded
Trial design
Design model
Sequential
Treatments tested in this trial
SER Familia
BehavioralSER 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).
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Familia SER (Salud, Estrés y Resilencia) GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From Enrollment to end of treatment at 6 weeks2
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.
Time frame
From Enrollment to end of treatment at 6 weeks3
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.
Time frame
From Enrollment to end of treatment at 6 weeks4
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.
Time frame
From Enrollment to end of treatment at 6 weeksOther outcomes
1
Perceptions of the impact of SER Familia on Parents and Youth as measured by semi-structured interviews
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)?
Time frame
From end of treatment at 6 weeks to the end of year twoSponsors and contacts
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Duke University
Lead sponsor
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
Source ClinicalTrials.gov