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Mental HealthNCT04875208

Seguimos Avanzando - Latino Youth Coping With Discrimination

An observational study of Mental Health, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall objective of this study is to investigate mediators and moderators at multiple ecological (individual, family/peer and school/neighborhood levels) and time-scale (micro- and macro-time) levels in the link between discrimination-related stressors and mental health among 340 Mexican-origin youth. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health
How many people
886 participants
Where
1 siteUnited States
Study dates
9 Apr 2021to 11 Oct 2024
Phase
Observational
Are there results?
None posted in the registry

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
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: * Mexican descent adolescents between the ages of 12-15 years old (at enrollment) * Mexican-Origin caregivers over the age of 18

Who may be able to join

  • Adolescent Inclusion Criteria:
  • The adolescent has two eligible caregivers (as defined in the following criteria)
  • The adolescent resides with at least one of the two caregivers.
  • One of the caregivers is a parent or legal guardian who is eligible to give consent for the child's participation.
  • Caregiver Inclusion Criteria:
  • Biological Parents of Mexican origin
Show all 9Show fewer
  • Legal guardians of Mexican origin
  • Step-parents of Mexican origin
  • A caregiver of Mexican origin identified by the parent/guardian who is 18 or older (e.g., grandparents, uncles/aunts, older siblings, godparents)

Who cannot join

  • A parent reports that the adolescent has a severe learning or developmental disability which would prevent understanding/survey response

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Notre Dame, William J. Shaw Center for Children and Families

    South Bend, Indiana, 46635

Other trials in United States

About this study

Official title: Latino Youth Coping With Discrimination: A Multi-Level Investigation in Micro- and Macro-Time

The overall objective of this study is to investigate mediators and moderators at multiple ecological (individual, family/peer and school/neighborhood levels) and time-scale (micro- and macro-time) levels in the link between discrimination-related stressors and mental health among 340 Mexican-origin youth.

Read the detailed description

The project's long-term goal is to improve the mental health of Mexican-origin youth by reducing the deleterious effects of racism, "othering," and negative neighborhood interactions. Community based collaboration will be used to recruit a sample of 340 Mexican-origin adolescents, mothers, and fathers in Indiana. The inclusion of fathers will be a valuable contribution to the literature, given the dearth of studies on Latinx fathers/stepfathers. A combination of annual surveys administered over three waves to parents and youth ("macro-time") and a 21-day daily diary ("micro-time") administered in wave 1 to youth is employed to assess important questions about how mediating and moderating processes unfold over time. Specific aims of the project include determination of within-person discrimination-related stressors that impact youth's mental health outcomes and the mechanisms of action at both micro- and macro- time levels; identification of protective factors that could help coping with discrimination related stressors and conditions under which they work; and elucidating youth, parent, and neighborhood risk factors that moderate the link between discrimination-related stressors and mental health outcomes in youth. This research is highly translational in that it will facilitate the development of more effective, culturally sensitive prevention and intervention strategies for Latinx youth and their families.

Conditions
Mental Health
Medical subject headings
Psychological Well-Being

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]

    Youth Depression, Total score 0-24, Higher scores are worse

    Measured: Time 0 (baseline)

  2. Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]

    Youth Depression, Total score 0-24, Higher scores are worse

    Measured: Month 12

  3. Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]

    Youth Depression, Total score 0-24, Higher scores are worse

    Measured: Month 24

  4. Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)

    Youth Anxiety, Subscale Total score 0-18, Higher scores are worse

    Measured: Time 0 (baseline)

  5. Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)

    Youth Anxiety, Subscale Total score 0-18, Higher scores are worse

    Measured: Month 12

  6. Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)

    Youth Anxiety, Subscale Total score 0-18, Higher scores are worse

    Measured: Month 24

  7. Youth Self-Report for Ages 11-18 (YSR/11-18)

    Youth Psychological Symptoms

    Measured: Time 0 (baseline)

  8. Youth Self-Report for Ages 11-18 (YSR/11-18)

    Youth Psychological Symptoms

    Measured: Month 12

  9. Youth Self-Report for Ages 11-18 (YSR/11-18)

    Youth Psychological Symptoms

    Measured: Month 24

  10. Child Behavior Checklist for Ages 6-18 (CBCL/6-18)

    Adaptive Functioning

    Measured: Time 0 (baseline)

  11. Child Behavior Checklist for Ages 6-18 (CBCL/6-18)

    Adaptive Functioning

    Measured: Month 12

  12. Child Behavior Checklist for Ages 6-18 (CBCL/6-18)

    Adaptive Functioning

    Measured: Month 24

  13. Pittsburgh Sleep Quality Index (PSQI)

    Sleep Duration and Quality; Total global score (for unadapted scale) 0-21

    Measured: Time 0 (baseline)

  14. Pittsburgh Sleep Quality Index (PSQI)

    Sleep Duration and Quality; Total global score (for unadapted scale) 0-21

    Measured: Month 12

  15. Pittsburgh Sleep Quality Index (PSQI)

    Sleep Duration and Quality; Total global score (for unadapted scale) 0-21

    Measured: Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start9 Apr 2021
  3. Primary completion11 Oct 2024
  4. Study completion11 Oct 2024

Resources

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
Other
Time perspective
Prospective
Enrolment
886 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04875208
Sponsor's protocol ID
2020P001721
Status last verified
Nov 2024
First submitted
9 Apr 2021
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Alegria M, Cruz-Gonzalez M, Yip T, Wang L, Fang Y, Park IJK, Xiong M, Fukuda M, Valentino K, Zhen-Duan J, Alvarez K, Shrout PE. Protective Factors of the Longitudinal Association Between Discrimination and Mental Health Among Mexican-Origin Youth. J Am Acad Child Adolesc Psychiatry. 2026 Jan 30:S0890-8567(26)00020-1. doi: 10.1016/j.jaac.2026.01.012. Online ahead of print.

    PubMed 41621613

  • Alegria M, Cruz-Gonzalez M, Yip T, Wang L, Park IJK, Fukuda M, Valentino K, Giraldo-Santiago N, Zhen-Duan J, Alvarez K, Barrutia XA, Shrout PE. Yearly and Daily Discrimination-Related Stressors and Mexican Youth's Mental Health and Sleep: Insights From the First Wave of a Three-Wave Family Study. J Am Acad Child Adolesc Psychiatry. 2024 Nov;63(11):1134-1148. doi: 10.1016/j.jaac.2023.12.010. Epub 2024 Feb 15.

    PubMed 38367767

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health, run by Massachusetts General Hospital 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 9 inclusion and 1 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: finished, as of the sponsor's last update on 29 Nov 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)] (time frame: Time 0 (baseline)). The study lists 15 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 NCT04875208, which also lists 2 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 29 Nov 2024.

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