NCT05863182

Brief Summary

The primary objective of this study is to develop and pilot-test a family-based Latino youth alcohol use preventive intervention for Latino youth (ages 14-16) and one of their parents. The preventive intervention will equip youth, parents, and families with skills to manage stress related to prejudice, discrimination, and racism as a means to reduce Latino youth alcohol use risk. Informed by ecodevelopmental, social norms, family stress, stress and coping theories, and racial socialization theories, the central hypothesis is that active coping skills can buffer against the negative effect of social stressors (i.e., experiences related to prejudice, discrimination, and racism) on youth alcohol outcomes/related risks/cognitions; and active coping skills can offset the negative effect of social stress on parental adjustment, family functioning and parenting behaviors, thereby reducing youth alcohol use risk. Using an iterative approach to intervention development, within a mixed-method research design, the purpose of this study is to construct intervention sessions that impart active coping skills to better manage social stress related to prejudice, discrimination, and racism. In Aim 1, we will use qualitative methods to inform the development of intervention sessions that target coping with prejudice, discrimination, and racism. I will conduct focus groups with youth (5 groups, n=6-8) and parents (5 groups, n=6-8) to identify how youth and parents experience and cope with perceived ethnic discrimination; the skills and resources they would like to further develop; and to seek input regarding the structure and logistics of the intervention. In Aim 2, we will create a family-based youth alcohol use preventive intervention curriculum that targets coping with prejudice, discrimination, and racism. I will identify strategies used in existing preventive interventions and draw from Aim 1 qualitative findings to develop tentative intervention sessions. We will then conduct focus groups with youth (5 groups, n=6-8) and parents (5 groups, n=6-8) to seek feedback on tentative intervention sessions. We will then integrate focus group data into the intervention curriculum and modify it accordingly and develop manuals in English and Spanish. In Aim 3, we will pilot test the intervention among Latino families (i.e., one youth and one parent) in Texas. We will pilot test the intervention with 60 families (i.e., youth-parent dyads; N=30 intervention group; N = 30 comparison group) from high schools in the Austin Independent School District to a) assess intervention feasibility and acceptability, and b) determine preliminary effect size estimates for the intervention's promise to improve youth and parent coping skills, family functioning, parenting behaviors, and youth alcohol outcomes.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

April 7, 2023

Last Update Submit

August 2, 2023

Conditions

Keywords

FamilyLatinoalcohol usepreventionracism

Outcome Measures

Primary Outcomes (2)

  • Coping Skills (Pre-assessment; week 1)

    COPING SKILLS will be assessed via the COPE, a multidimensional assessment of active and avoidant coping strategies. Youth and parents report the frequency of using a given coping strategy: 1 (Not at All) to 4 (A Lot). We will assess discrimination specific active and avoidant coping with the Coping with Discrimination Scale. The CDS is a modified version of the COPE and includes 18 items assessing general and 7 items assessing discrimination specific coping strategies. We will also use the General Help-Seeking Questionnaire (GHSQ), which taps into youth and parents' social support seeking. The GHSQ provides participants with a list of people from whom parents and youth seek help. Participants rate on a scale from 1 (Extremely Unlikely) to 7 (Extremely Likely) their likelihood of seeking help. Lastly, we will assess youth-parent communication with 6 items from the racial socialization scale. Participants rate on a scale 1 (Very Unlikely) to 5 (Very Likely) their racial socialization.

    Pre-assessment (week 1)

  • Coping Skills (Post-assessment; weeks 16-20)

    COPING SKILLS will be assessed via the COPE, a multidimensional assessment of active and avoidant coping strategies. Youth and parents report the frequency of using a given coping strategy: 1 (Not at All) to 4 (A Lot). We will assess discrimination specific active and avoidant coping with the Coping with Discrimination Scale which is a modified version of the COPE and includes 18 items assessing general and 7 items assessing discrimination specific coping strategies. We will also use the General Help-Seeking Questionnaire (GHSQ), which taps into youth and parents' social support seeking. The GHSQ provides participants with a list of people from whom parents and youth seek help. Participants rate on a scale from 1 (Extremely Unlikely) to 7 (Extremely Likely) their likelihood of seeking help. Lastly, we will assess youth-parent communication with 6 items from the racial socialization scale. Participants rate on a scale 1 (Very Unlikely) to 5 (Very Likely) their racial socialization.

    Pre-assessment (weeks 16-20)

Secondary Outcomes (4)

  • Alcohol Use Outcomes (Pre-assessment; week 1)

    Pre-assessment (week 1)

  • Alcohol Use Outcomes (Post-assessment; week 16-20)

    Post-assessment (week 16-20)

  • Family Functioning and Parenting Behaviors (Pre-assessment; week 1)

    Pre-assessment (week 1)

  • Family Functioning and Parenting Behaviors (Post-assessment; weeks 16-20)

    Post-assessment (week 16-20)

Study Arms (2)

Intervention Group

EXPERIMENTAL

Students and parents attending the intervention school, will participate in the family-based intervention.

Behavioral: Juntos Familia Family based intervention

Comparison Group

NO INTERVENTION

Students and parents attending the non-intervention school will not receive the intervention and serve as comparison group.

Interventions

Students and parents will participate in weekly 2.5 hour sessions around topics related to managing experiences with prejudice, discrimination and racism.

Intervention Group

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adolescents and caregivers (i.e., parents) in all of the study phases.
  • adolescents between the ages 14 and 16, enrolled in 9th or 10th grade.
  • adolescents must identify as "Hispanic," "Latino," or pan-ethnic labels.
  • caregivers/parents with a 9th or 10th grade adolescent living at home.
  • B. SAMPLING/SCHOOL SELECTION.
  • Austin Independent School District (AISD) for this project.
  • a high proportion of Latino students (\>70%).
  • a high proportion of students classified as economically disadvantaged (\>50%).
  • school enrollment of at least 1000 student.

You may not qualify if:

  • Non Hispanic students and parents;
  • Any Hispanic students and parents who don't meet above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Underage DrinkingAlcohol DrinkingRacism

Condition Hierarchy (Ancestors)

Adolescent BehaviorBehaviorDrinking BehaviorPrejudiceSocial BehaviorSocial Discrimination

Central Study Contacts

Elma Lorenzo-Blanco, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: cluster rct - will randomly assign 1/5 schools to serve as intervention school and 1/5 schools to serve as control school.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2023

First Posted

May 17, 2023

Study Start

February 1, 2024

Primary Completion

August 31, 2024

Study Completion

July 31, 2025

Last Updated

August 3, 2023

Record last verified: 2023-08