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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 12 to 100 years
• All sexes
• Healthy volunteers accepted
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Substance Abuse, Intimate Partner Violence (IPV), HIV Infections, Depression, Anxiety

Being tested

SER Familia

Keywords

Family, Stress, Resilience

Medical subject headings

Substance-Related Disorders, HIV Infections, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• SER FamiliaBehavioural

  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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: From Enrollment to end of treatment at 6 weeks

2. 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.

   Measured: From Enrollment to end of treatment at 6 weeks

3. 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.

   Measured: From Enrollment to end of treatment at 6 weeks

4. 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.

   Measured: From Enrollment to end of treatment at 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted4 Oct 2024
2. Study start30 Jun 2025
3. Primary completion31 Jul 2028 (estimated)
4. Study completion31 Jan 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Substance AbuseStudies of the same condition, open and under way.
• More trials run by Duke UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.