NCT04875208

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
886

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 9, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

April 9, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

3.5 years

First QC Date

April 9, 2021

Last Update Submit

November 26, 2024

Conditions

Mental Health

Outcome Measures

Primary Outcomes (15)

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

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

    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

    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

    Month 24

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

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

    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

    Month 12

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

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

    Month 24

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

    Youth Psychological Symptoms

    Time 0 (baseline)

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

    Youth Psychological Symptoms

    Month 12

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

    Youth Psychological Symptoms

    Month 24

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

    Adaptive Functioning

    Time 0 (baseline)

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

    Adaptive Functioning

    Month 12

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

    Adaptive Functioning

    Month 24

  • Pittsburgh Sleep Quality Index (PSQI)

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

    Time 0 (baseline)

  • Pittsburgh Sleep Quality Index (PSQI)

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

    Month 12

  • Pittsburgh Sleep Quality Index (PSQI)

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

    Month 24

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

South Bend, Indiana, 46635, United States

Location

Related Publications (1)

  • 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.

    PMID: 38367767DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Disparities Research Unit

Study Record Dates

First Submitted

April 9, 2021

First Posted

May 6, 2021

Study Start

April 9, 2021

Primary Completion

October 11, 2024

Study Completion

October 11, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

US(1)