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NCT Number: NCT07041931

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Mental Health Behavior Personal Satisfaction Psychological Well-Being

Age range

12 year and older

Sex eligibility

Female

Study type

Observational

Primary location

UCSF

San Francisco, California, 94110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

(Provider):

  • Not proficient in Spanish and/or English language
  • Not previously trained on the Voices-LITE intervention
  • Not approved to deliver the VOCES-NUEVAS intervention to students at OUSD schools/SBHC sites
  • Not leading a VOCES-NUEVAS group at an OUSD school/SBHC site during the 2024-2025 school year.

Treatment and study plan

Primary outcomes

  1. Youth Session Feedback Forms

    Time frame: 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 ("I loved it!" to "I didn't like it at all").

  2. Provider Session Feedback Forms

    Time frame: 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 ("Excellent" to "Terrible"), and provider feedback on their most favorite part of group, least favorite, and parts of group that need modification.

Secondary outcomes

  1. Demographics

    Time frame: 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.

  2. CAGE Adapted to Include Drugs (CAGE-IAD)

    Time frame: 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. 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.

  3. Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 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. 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.

  4. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Oakland Unified School District

Registry information

Official study title

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

Acronym: VOCES-NUEVAS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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