Mental HealthVOCES-NUEVASNCT07041931
Empowering Newcomer Voices: A Trauma-Informed, Gender-Responsive Group Intervention in Schools (VOCES-NUEVAS)
An observational study of Mental Health, run by University of California, San Francisco at 1 site in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 12 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Youth population: OUSD middle or high school students ages 12-18 years old that are interested in participating in the VOCES-NUEVAS group at an eligible OUSD/SBHC school site in Oakland, California. Provider population: OUSD Voices-LITE trained providers ages 18 years old or older, planning on running a VOCES-NUEVAS group at an eligible OUSD/SBHC school site in Oakland, California.
Who may be able to join
- 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
- 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
Who cannot join
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Empowering Newcomer VOICES by Implementing and Evaluating a Trauma- Informed and Gender-responsive Group Intervention in School and School-based Health Center Sites
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.
Read the 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.
- Conditions
- Mental Health
- Keywords
- school-based care, mental wellness, identity development, group interventions
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| school 1 | The first of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 2 | The second of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 3 | The third of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 4 | The fourth of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 5 | The fifth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 6 | The sixth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 7 | The seventh of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. | |
| school 8 | The eighth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Youth Session Feedback Forms
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").
Measured: Weekly for 8 weeks during the 8-week group intervention period
Provider Session Feedback Forms
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.
Measured: Weekly for 8 weeks during the 8-week group intervention period
Secondary outcomes (4)
Demographics
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.
Measured: Twice, once at baseline and once after the 8-week intervention period
CAGE Adapted to Include Drugs (CAGE-IAD)
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.
Measured: Twice, once at baseline and once after the 8-week intervention period
Generalized Anxiety Disorder-7 (GAD-7)
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.
Measured: Twice, once at baseline and once after the 8-week intervention period
Patient Health Questionnaire-9 (PHQ-9)
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.
Measured: Twice, once at baseline and once after the 8-week intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Mar 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Oakland Unified School District
- Responsible party
- Sponsor
- Investigators
- Lauren M Haack, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041931
- Sponsor's protocol ID
- 24-42289
- Other IDs
- 7500252
- Acronym
- VOCES-NUEVAS
- Status last verified
- Apr 2026
- First submitted
- 11 Jun 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our study involves a vulnerable population and sensitive topics, making privacy and confidentiality our top priority. To prevent potential re-identification and uphold participant trust, we are not sharing individual participant data (IPD). Our consent process assured strict confidentiality, and sharing even de-identified data could pose risks. However, we welcome inquiries about aggregated results and methodology.
Publications
Sidamon-Eristoff AE, Cohodes EM, Gee DG, Pena CJ. Trauma exposure and mental health outcomes among Central American and Mexican children held in immigration detention at the United States-Mexico border. Dev Psychobiol. 2022 Jan;64(1):e22227. doi: 10.1002/dev.22227.
PubMed 35050507Martinez-Donate AP, Verdecias N, Zhang X, Jesus Eduardo GF, Asadi-Gonzalez AA, Guendelman S, Amuedo-Dorantes C, Rangel G. Health Profile and Health Care Access of Mexican Migration Flows Traversing the Northern Border of Mexico. Med Care. 2020 May;58(5):474-482. doi: 10.1097/MLR.0000000000001300.
PubMed 32028523Almeida J, Johnson RM, Matsumoto A, Godette DC. Substance use, generation and time in the United States: the modifying role of gender for immigrant urban adolescents. Soc Sci Med. 2012 Dec;75(12):2069-75. doi: 10.1016/j.socscimed.2012.05.016. Epub 2012 Jun 7.
PubMed 22727651Cleary SD, Snead R, Dietz-Chavez D, Rivera I, Edberg MC. Immigrant Trauma and Mental Health Outcomes Among Latino Youth. J Immigr Minor Health. 2018 Oct;20(5):1053-1059. doi: 10.1007/s10903-017-0673-6.
PubMed 29139024Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: 10.1002/jts.22186. Epub 2017 Jun 6.
PubMed 28585740Bailey CA, Widener K. The nexus between immigration status, policy, and proceedings, and mental health. Curr Opin Psychol. 2022 Oct;47:101411. doi: 10.1016/j.copsyc.2022.101411. Epub 2022 Jul 3.
PubMed 35914487
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Newcomer VOICES by Implementing and Evaluating a Trauma- Informed and Gender-responsive Group Intervention in School and School-based Health Center Sites
- ClinicalTrials.gov ID
- NCT07041931
- Acronym / sponsor ID
- VOCES-NUEVAS / 24-42289
- Conditions
- Mental Health
- Keywords
- school-based care, mental wellness, identity development, group interventions
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Oakland Unified School District
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| school 1 | – | –The first of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 2 | – | –The second of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 3 | – | –The third of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 4 | – | –The fourth of 4 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 5 | – | –The fifth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 6 | – | –The sixth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 7 | – | –The seventh of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
| school 8 | – | –The eighth of 8 eligible Oakland Unified School District and/or school-based health center school sites recruited for this project. |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Youth population: OUSD middle or high school students ages 12-18 years old that are interested in participating in the VOCES-NUEVAS group at an eligible OUSD/SBHC school site in Oakland, California. Provider population: OUSD Voices-LITE trained providers ages 18 years old or older, planning on running a VOCES-NUEVAS group at an eligible OUSD/SBHC school site in Oakland, California.
Key inclusion criteria (8 listed)
- 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
- 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
Key exclusion criteria (8 listed)
- 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.
- Not proficient in Spanish and/or English language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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").
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.
4 secondary outcomes
Demographics
Time frame: Twice, once at baseline and once after the 8-week intervention period
CAGE Adapted to Include Drugs (CAGE-IAD)
Time frame: Twice, once at baseline and once after the 8-week intervention period
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Twice, once at baseline and once after the 8-week intervention period
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Twice, once at baseline and once after the 8-week intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 35050507Sidamon-Eristoff AE, Cohodes EM, Gee DG, Pena CJ. Trauma exposure and mental health outcomes among Central American and Mexican children held in immigration detention at the United States-Mexico border. Dev Psychobiol. 2022 Jan;64(1):e22227. doi: 10.1002/dev.22227.
- Background: PubMed 32028523Martinez-Donate AP, Verdecias N, Zhang X, Jesus Eduardo GF, Asadi-Gonzalez AA, Guendelman S, Amuedo-Dorantes C, Rangel G. Health Profile and Health Care Access of Mexican Migration Flows Traversing the Northern Border of Mexico. Med Care. 2020 May;58(5):474-482. doi: 10.1097/MLR.0000000000001300.
- Background: PubMed 22727651Almeida J, Johnson RM, Matsumoto A, Godette DC. Substance use, generation and time in the United States: the modifying role of gender for immigrant urban adolescents. Soc Sci Med. 2012 Dec;75(12):2069-75. doi: 10.1016/j.socscimed.2012.05.016. Epub 2012 Jun 7.
- Background: PubMed 29139024Cleary SD, Snead R, Dietz-Chavez D, Rivera I, Edberg MC. Immigrant Trauma and Mental Health Outcomes Among Latino Youth. J Immigr Minor Health. 2018 Oct;20(5):1053-1059. doi: 10.1007/s10903-017-0673-6.
- Background: PubMed 28585740Betancourt TS, Newnham EA, Birman D, Lee R, Ellis BH, Layne CM. Comparing Trauma Exposure, Mental Health Needs, and Service Utilization Across Clinical Samples of Refugee, Immigrant, and U.S.-Origin Children. J Trauma Stress. 2017 Jun;30(3):209-218. doi: 10.1002/jts.22186. Epub 2017 Jun 6.
- Background: PubMed 35914487Bailey CA, Widener K. The nexus between immigration status, policy, and proceedings, and mental health. Curr Opin Psychol. 2022 Oct;47:101411. doi: 10.1016/j.copsyc.2022.101411. Epub 2022 Jul 3.
- Individual participant dataSharing planned: No. Our study involves a vulnerable population and sensitive topics, making privacy and confidentiality our top priority. To prevent potential re-identification and uphold participant trust, we are not sharing individual participant data (IPD). Our consent process assured strict confidentiality, and sharing even de-identified data could pose risks. However, we welcome inquiries about aggregated results and methodology.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren M Haack, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mental Health, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Session Feedback Forms (time frame: Weekly for 8 weeks during the 8-week group intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041931, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.