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

Not yet recruiting

• Conditions: Mental Health

• Registration Number: NCT07041931
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-11
• Study First Submitted QC: 2025-06-18
• Last Update Submitted: 2025-06-18
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2026-08-01
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Youth Session Feedback Forms	Weekly for 8 weeks during the 8-week group intervention period	Participants 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.
Provider Session Feedback Forms	Weekly for 8 weeks during the 8-week group intervention period	Group 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, and provider feedback on their most favorite part of group, least favorite, and parts of group that need modification.

Secondary Outcome Measures

Name	Time	Method
Demographics	Twice, once at baseline and once after the 8-week intervention period	Participants 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.
Coping with Acculturative Stress in American Schools (CASAS-A)	Twice, once at baseline and once after the 8-week intervention period	Participants will complete this 18-question form once at baseline and again following the 8-week intervention period. The CASAS-A measure will ask the participants questions related to their experiences and emotions surrounding their acculturation experience in the United States.
Fears of Deportation	Twice, once at baseline and once after the 8-week intervention period	Participants will complete this 6-question form once at baseline and again following the 8-week intervention period.The Fears of Deportation measure includes questions related to fear and engagement with law enforcement such as if their family members have avoided reporting crimes and how deportation concerns impact their behaviors.
CAGE Adapted to Include Drugs (CAGE-IAD)	Twice, once at baseline and once after the 8-week intervention period	Participants 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.
Generalized Anxiety Disorder-7 (GAD-7)	Twice, once at baseline and once after the 8-week intervention period	Participants 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.
Patient Health Questionnaire-9 (PHQ-9)	Twice, once at baseline and once after the 8-week intervention period	Participants 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.

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States