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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04875208
Other study ID # 2020P001721
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 9, 2021
Est. completion date February 28, 2025

Study information

Verified date February 2024
Source Massachusetts General Hospital
Contact Margarita Alegria, Ph.D.
Phone 6177241237
Email malegria@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 900
Est. completion date February 28, 2025
Est. primary completion date February 28, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: 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 - 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) Exclusion Criteria: - A parent reports that the adolescent has a severe learning or developmental disability which would prevent understanding/survey response

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Notre Dame, William J. Shaw Center for Children and Families South Bend Indiana

Sponsors (4)

Lead Sponsor Collaborator
Massachusetts General Hospital Fordham University, Indiana University, University of Notre Dame

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Primary 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
Primary 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)
Primary Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED) Youth Anxiety, Subscale Total score 0-18, Higher scores are worse Month 12
Primary Screen for Child Anxiety Related Disorders/ [General Anxiety subscale only] (SCARED) Youth Anxiety, Subscale Total score 0-18, Higher scores are worse Month 24
Primary Youth Self-Report for Ages 11-18 (YSR/11-18) Youth Psychological Symptoms Time 0 (baseline)
Primary Youth Self-Report for Ages 11-18 (YSR/11-18) Youth Psychological Symptoms Month 12
Primary Youth Self-Report for Ages 11-18 (YSR/11-18) Youth Psychological Symptoms Month 24
Primary Child Behavior Checklist for Ages 6-18 (CBCL/6-18) Adaptive Functioning Time 0 (baseline)
Primary Child Behavior Checklist for Ages 6-18 (CBCL/6-18) Adaptive Functioning Month 12
Primary Child Behavior Checklist for Ages 6-18 (CBCL/6-18) Adaptive Functioning Month 24
Primary Pittsburgh Sleep Quality Index (PSQI) Sleep Duration and Quality; Total global score (for unadapted scale) 0-21 Time 0 (baseline)
Primary Pittsburgh Sleep Quality Index (PSQI) Sleep Duration and Quality; Total global score (for unadapted scale) 0-21 Month 12
Primary Pittsburgh Sleep Quality Index (PSQI) Sleep Duration and Quality; Total global score (for unadapted scale) 0-21 Month 24
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