NCT04156373

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

November 23, 2020

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4.6 years

First QC Date

October 10, 2019

Last Update Submit

January 13, 2026

Conditions

Keywords

immigrationcultural factorsprevention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Change in social connectedness measured by Los Angeles Family and Neighborhood Survey

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

  • Change in social connectedness measured by the Hemingway Adolescent Connectedness Scale

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

  • Change in familial connectedness measured by the Hemingway Adolescent Connectedness Scale

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

  • Change in academic connectedness measured by the Hemingway Adolescent Connectedness Scale

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

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

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

Other Outcomes (2)

  • Change in school attendance measured by school administrative records

    From the semester immediately preceding baseline assessment through the 12 months following baseline assessment.

  • Change in grades measured by school administrative records

    From the semester immediately preceding baseline assessment through the 12 months following baseline assessment.

Study Arms (2)

Fuerte

EXPERIMENTAL

This group will receive the Fuerte prevention program over the span of six to eight weeks.

Behavioral: Fuerte

Delayed waitlist control

NO INTERVENTION

This group will be the delayed waitlist control group. They will not receive the Fuerte prevention program until the following semester.

Interventions

FuerteBEHAVIORAL

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.

Fuerte

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Youth participant does not speak Spanish as a primary language, i.e., their primary language is an indigenous dialect/language.
  • 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.
  • Youth participant's primary language is Spanish.
  • Adult provider does not engage in providing services to MENA newcomer immigrant youth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Unified School District

San Francisco, California, 94114-2614, United States

Location

Related Publications (4)

  • 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.

    PMID: 25110972BACKGROUND
  • 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.

    PMID: 24385676BACKGROUND
  • 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.

    PMID: 27660898BACKGROUND
  • 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.

    PMID: 22040221BACKGROUND

MeSH Terms

Conditions

Psychological Trauma

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • William Martinez, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

November 7, 2019

Study Start

November 23, 2020

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

January 15, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations