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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04156373
Other study ID # 19-28075
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date November 23, 2020
Est. completion date June 30, 2024

Study information

Verified date August 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 400
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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.

Study Design


Intervention

Behavioral:
Fuerte
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.

Locations

Country Name City State
United States San Francisco Unified School District San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco San Francisco Department of Public Health

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Immediately before intervention, immediately after intervention, and 3-months post intervention
Secondary 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. Immediately before intervention, immediately after intervention, and 3-months post intervention
Secondary 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. Immediately before intervention, immediately after intervention, and 3-months post intervention
Secondary 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. Immediately before intervention, immediately after intervention, and 3-months post intervention
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