NCT07041931

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
5mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Mar 2025Dec 2026

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

June 11, 2025

Last Update Submit

April 15, 2026

Conditions

Keywords

school-based caremental wellnessidentity developmentgroup interventions

Outcome Measures

Primary Outcomes (2)

  • 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").

    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.

    Weekly for 8 weeks during the 8-week group intervention period

Secondary Outcomes (4)

  • Demographics

    Twice, once at baseline and once after the 8-week intervention period

  • CAGE Adapted to Include Drugs (CAGE-IAD)

    Twice, once at baseline and once after the 8-week intervention period

  • Generalized Anxiety Disorder-7 (GAD-7)

    Twice, once at baseline and once after the 8-week intervention period

  • Patient Health Questionnaire-9 (PHQ-9)

    Twice, once at baseline and once after the 8-week intervention period

Study Arms (8)

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.

Eligibility Criteria

Age12 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligible participants include young people of any sex assigned at birth or gender expression who relate to or identify with the experiences of girls and women in society today.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF

San Francisco, California, 94110, United States

Location

Related Publications (6)

  • 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.

    PMID: 35050507BACKGROUND
  • Martinez-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.

    PMID: 32028523BACKGROUND
  • Almeida 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.

    PMID: 22727651BACKGROUND
  • Cleary 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.

    PMID: 29139024BACKGROUND
  • Betancourt 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.

    PMID: 28585740BACKGROUND
  • Bailey 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.

    PMID: 35914487BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Lauren M Haack, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2025

First Posted

June 27, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations