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Empowering Newcomer Voices: A Trauma-Informed, Gender-Responsive Group Intervention in Schools (VOCES-NUEVAS)

Empowering Newcomer VOICES by Implementing and Evaluating a Trauma- Informed and Gender-responsive Group Intervention in School and School-based Health Center Sites

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07041931
Acronym
VOCES-NUEVAS
Enrollment
24
Registered
2025-06-27
Start date
2025-03-01
Completion date
2026-12-01
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health

Keywords

school-based care, mental wellness, identity development, group interventions

Brief summary

The goal of this study is to see if VOCES-NUEVAS, a school-based program for newcomer girls from Latin America, is helpful and easy to use. The main questions the investigators want to answer are: * Is VOCES-NUEVAS a good fit for newcomer girls in schools? * Does it help improve their mental health and well-being? Students who are already part of the VOCES-NUEVAS program at four school-based health centers will take short surveys before and after the program and give feedback after each session. The adults leading the program will also share their thoughts in group discussions or interviews. The results will help improve the program and prepare for a larger study in the future.

Detailed description

The number of newcomer youth from Latin America entering the U.S. has surged recently, with border crossings reaching a 20-year high. These youth face mental and stress-related health challenges compared to their non-migrant peers, including higher trauma symptoms, substance use, and psychosocial issues. Culturally attuned, evidence-based interventions in trusted settings like schools and school-based health centers (SBHCs) could address these needs. VOICES-LITE, a gender and trauma-responsive intervention for adolescent female-identifying students, aligns well with these needs. After piloting VOICES-LITE in Spanish with newcomer youth, local partners found it feasible and acceptable. However, feedback indicated that further cultural adaptations are needed to better fit the specific context and population. The investigators propose a hybrid effectiveness-implementation study to evaluate the culturally adapted intervention, VOCES-NUEVAS. This study will involve an open trial at four selected OUSD school/SBHC sites to assess the feasibility, acceptability, and effectiveness of the intervention, providing insights for further refinement ahead of a future R01 trial. The four participating sites will be selected from OUSD/SBHC locations that serve newcomer students (see attached site list), based on the availability of providers who are facilitating the VOCES-NUEVAS group and have agreed to participate in the research. Providers who are already scheduled to implement the intervention with newcomer students at these sites will be recruited for the study. The investigators will assess whether the culturally adapted VOCES-NUEVAS manual and implementation guide used in schools sufficiently address the needs of newcomer students and their supporting providers. Students participating in the intervention at these sites will be recruited to participate in the current study. They will be asked to complete pre- and post-intervention questionnaires and provide session-by-session feedback to further improve the intervention. Both participating providers and students will also be asked to participate in a focus group or exit interview to provide additional feedback. Results from the study will be shared with community stakeholders and used in future research, including a future R01 randomized-controlled trial to assess VOCES-NUEVAS's impact on newcomer students' mental health, substance use, and long-term outcomes. This future trial will be a separate IRB application from the current study.

Interventions

None listed

Sponsors

University of California, San Francisco
Lead SponsorOTHER
Oakland Unified School District
CollaboratorUNKNOWN

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

(Youth): * current students of an Oakland Unified School District (OUSD) and/or School-based Health Center (SBHC) middle or high school site * Eligible and registered to participate in a VOCES NUEVAS group during the 2024-2025 or 2025-2026 school year

Exclusion criteria

(Youth): * Not proficient in Spanish * Unable to provide informed consent or assent * Does not meet eligibility criteria to participate in VOCES-NUEVAS intervention * Not enrolled as a middle or high school at an OUSD school/SBHC site. Inclusion Criteria (Provider): * aged 18 years old or older * current social worker or school provider working at one of the eligible Oakland Unified School District and/or School-based Health Center middle or high school sites * Facilitating a VOCES NUEVAS group during the 2024-2025 or 2025-2026 school year * Eligible to deliver school services at OUSD school/school-based health center sites * Previously trained on Voices-LITE curriculum * proficient in English and Spanish

Design outcomes

Primary

MeasureTime frameDescription
Youth Session Feedback FormsWeekly for 8 weeks during the 8-week group intervention periodParticipants will complete this 8-question form immediately following completion of group session. Questions are related to overall impressions of the group, how useful the group was, and how connected they felt with other participants and facilitators, whether they would recommend the group to others, and then rating each session activity on a 5-point scale ("I loved it!" to "I didn't like it at all").
Provider Session Feedback FormsWeekly for 8 weeks during the 8-week group intervention periodGroup providers will complete this 15-question form immediately following completion of group session. Questions are related to number of attendees, what activities were completed, impressions of group participant engagement and comprehension for each activity ("Excellent" to "Terrible"), and provider feedback on their most favorite part of group, least favorite, and parts of group that need modification.

Secondary

MeasureTime frameDescription
DemographicsTwice, once at baseline and once after the 8-week intervention periodParticipants will complete this 13-question form once at baseline and again following the 8-week intervention period. The Demographic measure will ask the participants questions related to their background (e.g. age, country of origin, languages spoken), history of migration and settlement, educational background, gender identity, and sexual orientation.
CAGE Adapted to Include Drugs (CAGE-IAD)Twice, once at baseline and once after the 8-week intervention periodParticipants will complete this 8-question form once at baseline and again following the 8-week intervention period. The CAGE-IAD measure will ask the participants questions related to concerning alcohol and drug usage. The questions utilize a "yes" or "no" format with one or more "yes's" indicating a possible substance use issue and 2 or more "yes's" indicating a likely substance use issue.
Generalized Anxiety Disorder-7 (GAD-7)Twice, once at baseline and once after the 8-week intervention periodParticipants will complete this 7-question form once at baseline and again following the 8-week intervention period. The GAD-7 measure will assess the severity of participants' anxiety. Questions are asked on a 5-point Likert scale ("Not at all" to "Nearly every day") with the answers summed to determine the severity of the participant's anxiety. Scores between 0-4 are considered minimal, 5-9 are considered mild, 10-14 are considered moderate, and 15-21 are considered severe.
Patient Health Questionnaire-9 (PHQ-9)Twice, once at baseline and once after the 8-week intervention periodParticipants will complete this 9-question form once at baseline and again following the 8-week intervention period. The PHQ-9 measure will assess the severity of participants' depression. Questions are asked on a 5-point Likert scale ("Not at all" to "Nearly every day") with the answers summed to determine the severity of the participant's anxiety. Scores between 0-4 are considered minimal, 5-9 are considered mild, 10-14 are considered moderate, 15-21 are considered moderately severe, and 20-27 are considered severe.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLauren M Haack, PhD

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026