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Fuerte Program for Newcomer Immigrant Youth (Fuerte)

Primary Purpose

Trauma, Psychological, Mental Disorder in Adolescence, Adolescent - Emotional Problem

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fuerte
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Trauma, Psychological focused on measuring immigration, cultural factors, prevention

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Fuerte RCT Inclusion Criteria:

  • SFUSD High School student
  • 12 to 18 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 18 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.

Sites / Locations

  • San Francisco Unified School District

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fuerte

Delayed waitlist control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in perceived experience with discrimination measured by the Negative Immigrant Community Experience Scale (NICE)
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 8 items. Max score of 54. High scores reflect a strong negative experiences of discrimination or negative perceptions of the discrimination.
Change in Perceived language ability pressures measured by the Negative Immigrant Community Experience Scale (NICE)
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 7 items. Max score of 42. High scores reflect a strong negative experiences of language ability pressure or negative perceptions of language ability pressure.
Change in Perceived negative community climate measured by the Negative Immigrant Community Experience Scale (NICE)
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 12 items. Max score of 84. High scores reflect a strong negative experiences within the community climate or negative perceptions of the community climate context.

Full Information

First Posted
October 10, 2019
Last Updated
August 2, 2023
Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT04156373
Brief Title
Fuerte Program for Newcomer Immigrant Youth
Acronym
Fuerte
Official Title
Fuerte: Evaluating a School-based Prevention Program for Newcomer Immigrant Youth at Risk for Traumatic Stress
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 23, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
San Francisco Department of Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Psychological, Mental Disorder in Adolescence, Adolescent - Emotional Problem
Keywords
immigration, cultural factors, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fuerte
Arm Type
Experimental
Arm Description
This group will receive the Fuerte prevention program over the span of six to eight weeks.
Arm Title
Delayed waitlist control
Arm Type
No Intervention
Arm Description
This group will be the delayed waitlist control group. They will not receive the Fuerte prevention program until the following semester.
Intervention Type
Behavioral
Intervention Name(s)
Fuerte
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in linkages to specialty mental health services for at-risk identified youth by the Pediatric Symptom Checklist - 35.
Description
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.
Time Frame
Immediately before intervention, immediately after intervention, and 3-months post intervention
Secondary Outcome Measure Information:
Title
Change in social connectedness measured by Los Angeles Family and Neighborhood Survey
Description
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.
Time Frame
Immediately before intervention, immediately after intervention, and 3-months post intervention
Title
Change in perceived experience with discrimination measured by the Negative Immigrant Community Experience Scale (NICE)
Description
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 8 items. Max score of 54. High scores reflect a strong negative experiences of discrimination or negative perceptions of the discrimination.
Time Frame
Immediately before intervention, immediately after intervention, and 3-months post intervention
Title
Change in Perceived language ability pressures measured by the Negative Immigrant Community Experience Scale (NICE)
Description
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 7 items. Max score of 42. High scores reflect a strong negative experiences of language ability pressure or negative perceptions of language ability pressure.
Time Frame
Immediately before intervention, immediately after intervention, and 3-months post intervention
Title
Change in Perceived negative community climate measured by the Negative Immigrant Community Experience Scale (NICE)
Description
Negative Immigrant Community Experience (NICE) scale. 7-point Likert scale (1 = Strongly disagree, 7 = Strongly agree). 12 items. Max score of 84. High scores reflect a strong negative experiences within the community climate or negative perceptions of the community climate context.
Time Frame
Immediately before intervention, immediately after intervention, and 3-months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Martinez, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco Unified School District
City
San Francisco
State/Province
California
ZIP/Postal Code
94114-2614
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25110972
Citation
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.
Results Reference
background
PubMed Identifier
24385676
Citation
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.
Results Reference
background
PubMed Identifier
27660898
Citation
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.
Results Reference
background
PubMed Identifier
22040221
Citation
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.
Results Reference
background

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Fuerte Program for Newcomer Immigrant Youth

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