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.
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
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.
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)
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
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
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)
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
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
Youth Self-Report for Ages 11-18 (YSR/11-18)
Youth Psychological Symptoms
Measured: Time 0 (baseline)
Youth Self-Report for Ages 11-18 (YSR/11-18)
Youth Psychological Symptoms
Measured: Month 12
Youth Self-Report for Ages 11-18 (YSR/11-18)
Youth Psychological Symptoms
Measured: Month 24
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Adaptive Functioning
Measured: Time 0 (baseline)
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Adaptive Functioning
Measured: Month 12
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Adaptive Functioning
Measured: Month 24
Pittsburgh Sleep Quality Index (PSQI)
Sleep Duration and Quality; Total global score (for unadapted scale) 0-21
Measured: Time 0 (baseline)
Pittsburgh Sleep Quality Index (PSQI)
Sleep Duration and Quality; Total global score (for unadapted scale) 0-21
Measured: Month 12
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.
- First posted6 May 2021
- Study start9 Apr 2021
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Massachusetts General HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Notre Dame, Fordham University, Indiana University
- Responsible party
- Principal investigator, Margarita Alegria, PhD, Massachusetts General Hospital
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 41621613Alegria 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Latino Youth Coping With Discrimination: A Multi-Level Investigation in Micro- and Macro-Time
- ClinicalTrials.gov ID
- NCT04875208
- Acronym / sponsor ID
- 2020P001721
- Conditions
- Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University of Notre Dame, Fordham University, Indiana University
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 6 May 2021 (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 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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (9 listed)
- 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.
- Biological Parents of Mexican origin
- Legal guardians of Mexican origin
Key exclusion criteria (1 listed)
- A parent reports that the adolescent has a severe learning or developmental disability which would prevent understanding/survey response
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
Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]
Time frame: Time 0 (baseline)
Youth Depression, Total score 0-24, Higher scores are worse
Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]
Time frame: Month 12
Youth Depression, Total score 0-24, Higher scores are worse
Children's Depression Inventory 2nd Edition™: Self-Report Short Form [(CDI-2: SR(S)]
Time frame: Month 24
Youth Depression, Total score 0-24, Higher scores are worse
Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)
Time frame: Time 0 (baseline)
Youth Anxiety, Subscale Total score 0-18, Higher scores are worse
Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)
Time frame: Month 12
Youth Anxiety, Subscale Total score 0-18, Higher scores are worse
Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED)
Time frame: Month 24
Youth Anxiety, Subscale Total score 0-18, Higher scores are worse
Youth Self-Report for Ages 11-18 (YSR/11-18)
Time frame: Time 0 (baseline)
Youth Psychological Symptoms
Youth Self-Report for Ages 11-18 (YSR/11-18)
Time frame: Month 12
Youth Psychological Symptoms
Youth Self-Report for Ages 11-18 (YSR/11-18)
Time frame: Month 24
Youth Psychological Symptoms
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Time frame: Time 0 (baseline)
Adaptive Functioning
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Time frame: Month 12
Adaptive Functioning
Child Behavior Checklist for Ages 6-18 (CBCL/6-18)
Time frame: Month 24
Adaptive Functioning
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Time 0 (baseline)
Sleep Duration and Quality; Total global score (for unadapted scale) 0-21
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Month 12
Sleep Duration and Quality; Total global score (for unadapted scale) 0-21
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Month 24
Sleep Duration and Quality; Total global score (for unadapted scale) 0-21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 41621613Alegria 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.
- Derived from this study: PubMed 38367767Alegria 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.