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Trauma, PsychologicalFuerteNCT04156373

Fuerte Program for Newcomer Immigrant Youth

A study testing Fuerte in people with Trauma, Psychological and Mental Disorder in Adolescence, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The present study is a randomized control trial to evaluate the efficacy and effectiveness of a school-based group prevention program (Fuerte) in San Francisco Unified School District Public Schools. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
What is being tested?
Fuerte
Could I receive a placebo?
No, everyone receives an active treatment
How many people
321 participants
Where
1 siteUnited States
Study dates
23 Nov 2020to 30 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Fuerte RCT Inclusion Criteria:

  • SFUSD High School student
  • 12 to 20 years old
  • Recent Immigrant to the US (within five years of enrollment date)
  • Country of origin is from Spanish-speaking Latin American countries
  • Participant is fluent in Spanish
  • Has not completed a Fuerte group in the past

Fuerte Facilitator and Support Staff Focus Group Inclusion Criteria:

-Must have been a facilitator for a Fuerte group after 2019 or work for a school or community-based organization directly involved in implementing a Fuerte group after 2019.

Fuerte Adaptation for MENA/Arabic-Speaking Focus Groups Inclusion Criteria:

  • SFUSD High School student
  • 12 to 20 years old
  • Recent Immigrant to the US (within five years of enrollment date)
  • Country of origin is Middle East or North African country.
  • Participant is fluent in Arabic.

MENA/Arabic-Speaking Provider Focus Group inclusion criteria:

-Works for an organization that provides behavioral health, educational, and/or social services to Arabic-speaking families in San Francisco county.

Fuerte RCT Exclusion Criteria:

-Youth participant does not speak Spanish as a primary language, i.e., their primary language is an indigenous dialect/language.

Fuerte Facilitator and Support Staff Focus Group Exclusion Criteria:

-Provider has not facilitated Fuerte after 2019 or does not work for a school or community-based organization directly involved in implementing a Fuerte group after 2019.

Fuerte Adaptation for MENA/Arabic-Speaking Focus Groups Exclusion Criteria:

  • Youth participant's primary language is Spanish.
  • Adult provider does not engage in providing services to MENA newcomer immigrant youth.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • San Francisco Unified School District

    San Francisco, California, 94114-2614

Other trials in United States

About this study

Official title: Fuerte: Evaluating a School-based Prevention Program for Newcomer Immigrant Youth at Risk for Traumatic Stress

The present study is a randomized control trial to evaluate the efficacy and effectiveness of a school-based group prevention program (Fuerte) in San Francisco Unified School District Public Schools. In addition, the present study will also inform effective procedures for adaptations of the Fuerte program for Latinx newcomer immigrant children and other newcomer immigrant youth from non-Latin American countries. Fuerte targets newcomer Latinx immigrant youth (five years or less post arrival in the U.S.) who are at risk of experiencing traumatic stress. In particular, the Fuerte program focuses on increasing youth's mental health literacy, improving their social functioning, and identifying and connecting at-risk youth to specialty mental health services. The program will be implemented by mental health providers from various county community-based organizations, as well as from the SFUSD Wellness Centers, who already offer mental health services in SFUSD schools.

Read the detailed description

Fuerte is a new prevention program that is being introduced into the mental health system of California in order to reduce behavioral health disparities among Latinx newcomer youth. School- based, preventative programming has been proposed to be the frontline for reducing behavioral health access disparities among Latinx newcomer youth. However, very few evidence-based, selective prevention programs exist that have been tailored to ensure cultural relevance for newcomer Latinx youth with limited English proficiency and low health literacy in under-resourced school settings. Like many urban school districts in California, San Francisco Unified School District is an especially relevant setting for the Fuerte program. The district has a high number of newcomer adolescents, with an average of over 500 newcomer adolescents coming into the school district per year, most from Central America and Mexico.

The Fuerte program promotes interagency and community collaboration with the explicit goals of increasing mental health literacy and service access, as it has been largely enacted through a unique collaboration between the San Francisco Unified School District, the San Francisco Department of Public Health, and the Departments of Psychiatry and Pediatrics at the University of California, San Francisco due to their common need for prevention programming for this high-needs population. Much of the curriculum of Fuerte was developed and adapted through feedback from newcomer immigrant youth and their families, as well as providers of the program. In addition, Fuerte's system of care facilitates the transition to services for youth to improve their overall functioning, including behavioral health care, medical care, educational, legal, and other services.

The Fuerte program is designed for youth ages 12 to 18 in the San Francisco Unified School District (SFUSD). In order to optimize the exposure of large number of immigrant youth with limited healthcare providers, Fuerte is designed as a group format, each group comprised of 4-8 participants. This has the additional benefit of fostering a sense of community and normalizing the therapeutic process in a supportive group setting. Participants are recruited through referrals from educators and staff in the Wellness Initiative, health centers that are co-located in schools throughout the district. Group leaders are bilingual behavioral health providers from both the school district and community-based organizations with experience working with newcomer Latinx youth.

Students will be randomized into either the Fuerte program or a delayed waitlist control group (DWC) once they are identified. In addition, focus groups will be held at the end of each group with the group participants, as well as with the group, and other newcomer immigrant students. These focus groups will assess positive aspects of Fuerte and areas of improvement as well as procedures for the implementation, sustainment, and adaptation of the program.

Additionally, we will be holding focus groups with Arabic-speaking, Middle Eastern/North African youth and community providers to help inform the adaptation of the current Fuerte curriculum for these populations. Youth will participate in a one-time focus group in order to assess the mental health and immigration-related social needs of Arabic-speaking youth. The focus groups will be held at the school and a number of questions will be posed to the group based on a framework for cultural adaptations of evidence-based programs. Additionally, focus groups will be held with adults who provide services to Middle Eastern/North African families residing in San Francisco County. Focus group questions will focus on barriers and facilitators to treatment access to these youth, and get feedback on the current Fuerte curriculum to get considerations on adaptation. The themes collected from both the youth and community provider groups will inform a future adaptation of the Fuerte program for this particular population.

Being tested
Fuerte
Keywords
immigration, cultural factors, prevention
Medical subject headings
Psychological Trauma

What participants receive

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

  • FuerteBehavioural

    Fuerte is a prevention program targeting youth at risk for psychological trauma who are recent immigrants to the United States. The program is evidence-informed using cognitive-behavioral principles and the Attachment, Regulation, and Competency (ARC) model for treating psychological trauma.

Study groups in NCT04156373
Study groupRoleWhat they receive
FuerteExperimentalThis group will receive the Fuerte prevention program over the span of six to eight weeks.
Receives: Behavioral: Fuerte
Delayed waitlist controlNo interventionThis group will be the delayed waitlist control group. They will not receive the Fuerte prevention program until the following semester.

What is being measured

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

  1. Change in linkages to specialty mental health services for at-risk identified youth by the Pediatric Symptom Checklist - 35.

    Percentage of participants needing a specialty mental health referral identified by the PSC-35 (Scored 28 or above) who were effectively linked to services.

    Pediatric Symptom Checklist for Children - 35 (screener to identify at-risk youth) (3 point symptom scale rating = "Never," "Sometimes," or "Often" present and scored 0, 1, and 2, respectively). This measure contains 35 questions, that can be scored for a total maximum score of 70. Higher score indicate more severe symptoms. A higher composite score of 28 or above indicates clinical concern and need for further evaluation.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

Secondary outcomes (5)
  1. Change in social connectedness measured by Los Angeles Family and Neighborhood Survey

    Change in social contentedness factors experienced by participants in school and neighborhood.

    -Neighborhood and School Relationships measure (items measuring friendships in school and community taken from items from the Los Angeles Family and Neighborhood Survey) Items B1-B5. Not scored on a composite score. Answer options are "Most," "Some," "None," for B2 and B3, "Yes," "No" for B4 and "Yes,"sometimes yes and sometimes no," and "no" for B5.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

  2. Change in social connectedness measured by the Hemingway Adolescent Connectedness Scale

    Hemingway Adolescent Connectedness sub-scale. 5-point Likert scale (1 = Not at all true, 5 = Very true). 12 items. Max score of 60. High scores indicate a stronger sense of social connectedness.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

  3. Change in familial connectedness measured by the Hemingway Adolescent Connectedness Scale

    Hemingway Adolescent Connectedness sub-scale. 5-point Likert scale (1 = Not at all true, 5 = Very True). 11 items. Max score of 55. High scores reflect a stronger perceived connectedness with parents and siblings.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

  4. Change in academic connectedness measured by the Hemingway Adolescent Connectedness Scale

    Hemingway Adolescent Connectedness sub-scale. 5-point Likert scale (1 = Not at all true, 7 = Very true). 18 items. Max score of 90. High scores reflect a stronger perceived connection with school, peers, and teachers.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

  5. Change in connectedness-to-self measured by the Hemingway Adolescent Connectedness Scale

    Hemingway Adolescent Connectedness sub-scale. 5-point Likert scale (1 = Not at all true, 5 = Very true). 12 items. Max score of 60. High scores indicate a stronger connection to one's self in the present and future.

    Measured: Immediately before intervention, immediately after intervention, and 3-months post intervention

Timeline

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

  1. First posted7 Nov 2019
  2. Study start23 Nov 2020
  3. Primary completion30 Jun 2025
  4. Study completion30 Jun 2025

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156373
Sponsor's protocol ID
19-28075
Acronym
Fuerte
Status last verified
Jan 2026
First submitted
10 Oct 2019
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brabeck KM, Lykes MB, Hunter C. The psychosocial impact of detention and deportation on U.S. migrant children and families. Am J Orthopsychiatry. 2014 Sep;84(5):496-505. doi: 10.1037/ort0000011. Epub 2014 Aug 11.

    PubMed 25110972
  • Perreira KM, Ornelas I. Painful Passages: Traumatic Experiences and Post-Traumatic Stress among Immigrant Latino Adolescents and their Primary Caregivers. Int Migr Rev. 2013 Dec;47(4):10.1111/imre.12050. doi: 10.1111/imre.12050.

    PubMed 24385676
  • Sawyer CB, Marquez J. Senseless Violence Against Central American Unaccompanied Minors: Historical Background and Call for Help. J Psychol. 2017 Jan 2;151(1):69-75. doi: 10.1080/00223980.2016.1226743. Epub 2016 Sep 23.

    PubMed 27660898
  • Jorm AF. Mental health literacy: empowering the community to take action for better mental health. Am Psychol. 2012 Apr;67(3):231-43. doi: 10.1037/a0025957. Epub 2011 Oct 31.

    PubMed 22040221

Questions about this trial

What is this clinical trial studying?

A study testing Fuerte in people with Trauma, Psychological and Mental Disorder in Adolescence, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in linkages to specialty mental health services for at-risk identified youth by the Pediatric Symptom Checklist - 35. (time frame: Immediately before intervention, immediately after intervention, and 3-months post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04156373, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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