Recruiting

FCU-L Online

Sponsor:

University of Oregon

Code:

NCT07025083

Conditions

Substance Use (Drugs, Alcohol)

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Interventions

Adapted Family Check-Up Online

Original Family Check-Up Online

Study Details

Brief summary:

Latinx people are the largest and fastest growing minority population in the U.S., yet most lack access to community responsive preventative interventions to reduce substance use among youth. Effective implementation of evidence-based interventions that can be delivered online is critical to reduce substance use and problem behaviors among ethnic populations and to scale up for broad dissemination. Adaptation to address community needs has improved parenting practices and youth outcomes beyond the original evidence-based parenting interventions, and adapted parenting programs have the potential to improve cultural socialization, which is associated with improved behavioral outcomes among Latinx youth. However, ongoing tensions in the field highlight the question of whether deep adaptations compared to surface-level adaptations (e.g., translation only) are needed. The FCU is an evidence-based parenting program that has a strong history of reducing substance abuse and externalizing symptoms (e.g., problem behaviors). A community-based participatory approach will be employed to culturally adapt the FCU Online and identify implementation strategies to improve access to and adoption of the intervention, leveraging community and resiliency-promoting assets. Promotores de salud, Spanish-speaking community health workers in an existing community-based research network will deliver the program. To reach the goals of the study, the following aims will guide this research. In Aim 1, a community advisory board of 6 parents and 6 promotores de salud will meet monthly to guide the ecological adaptation of the FCU Online modules and implementation strategies with promotores. In Aim 2, the online version of the intervention will be adapted using iterative Plan-Do-Study-Act cycles to get usability feedback from members of the community advisory board, consistent with best practices designed to adapt interventions in community settings. In Aim 3, using a Hybrid 1, mixed methods design, researchers will assess feasibility, accessibility, adoption, and potential effectiveness of the adapted intervention, FCU-L Online. The team will recruit 108 Latinx families into a 3-arm wait-list randomized control trial: n=36 in the culturally adapted FCU-L Online (e.g., deep adaptation), n=36 in the FCU Online in Spanish without adaptation (e.g., surface level adaptation), and n= 36 in a waitlist control group. Feasibility, accessibility, and adoption will be assessed according to quantitative benchmarks, and qualitative feedback will assess the barriers and facilitators of implementation. Potential effectiveness will be assessed (p < .15), including improvement of key intervention mechanisms (parenting practices, parenting efficacy, and cultural socialization) as well as child outcomes (substance use, intentions to use, and externalizing behavior). Findings from this study will inform a Hybrid II randomized controlled implementation trial to test effectiveness while scaling up dissemination of the FCU-L Online. This research could ultimately reduce lifetime risk for substance use among Latinx youth by improving parenting practices and supporting cultural socialization.

Conditions

Substance Use (Drugs, Alcohol)

Study ID

NCT07025083

Start date

Dec 19, 2025

Status verified date

May, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 14

Healthy Volunteers: Accepted

Parent Inclusion Criteria:

  • being a self-identified Latinx parent or guardian of a youth age 11-14
  • speaking Spanish
  • cognitively able to complete a brief screener
  • assessments at a 6th grade reading level
  • willing to participate in an online intervention
  • willing for their child to complete confidential assessments

Youth Inclusion Criteria:

  • being a middle school student age 11-14
  • reading at the 2nd grade level in English or Spanish

Exclusion Criteria:

  • having low concerns on the Positive Family Support screener

Study Design

Enrollment

108 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Family Check-Up Online Adapted for Latinx Families

In this arm, participants will receive the Family Check-Up Online adapted for Latinx families plus telehealth support from a promotore de salud.

experimental: Original Family Check-Up Online

In this arm, participants will receive the original Family Check-Up online in Spanish.

no intervention: Waitlist Control

The waitlist control group will not receive the intervention during the trial, but will have the option to participate in the Family Check-Up Online after the trial is over.

Interventions

Adapted Family Check-Up Online

The Family Check-Up Online is a digital intervention that includes an assessment, computer-generated feedback, and intervention modules that focus on improving family relationships and parenting skills in order to reduce child mental health problems and to improve child self-regulation. These modules include Healthy Behaviors for Stressful Times, Positive Parenting, Rules and Consequences, Supporting School Success, and Communication. In addition, two modules for Latinx families are being added in the adapted version. This version represents a deep adaptation.

Original Family Check-Up Online

This version is the original Family Check Up Online translated into Spanish without the adaptions. This represents a surface-level adaptation.

Primary outcome measure

  • Telehealth Usability Questionnaire [ Time Frame: 3 months ]
  • Consumer Satisfaction Questionnaire [ Time Frame: 3 months ]
  • Parenting Sense of Competency [ Time Frame: baseline, 3 months, 6 months ]
  • Latino Immigration Family Socialization Scale [ Time Frame: baseline, 3 months, 6 months ]
  • Adaptation of Parenting Young Children [ Time Frame: baseline, 3 months, 6 months ]

Central Contacts and Locations

Central contacts

Anne-Marie M Mauricio, PhD

541-346-3630amariem@uoregon.edu

Locations

University of Oregon

Recruiting

Eugene, Oregon, United States, 97403

Contacts

More Information

Sponsor

University of Oregon

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

  • adolescence
  • parenting
  • adaptation
  • family
  • substance use intent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-05. This information was provided to ClinicalTrials.gov by University of Oregon on 2026-06-04.