Clinical trial NCT07025083: Adaptation of the Family Check-Up Online
Official title: Adaptation of Family Check-Up Online in the Latinx Community to Reduce Youth Substance Use
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Use (Drugs, Alcohol)
Keywords: adolescence
parenting
adaptation
family
substance use intent
Lead sponsor: University of Oregon
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-17
Enrollment: 108
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 96 Latinx families into a 3-arm wait-list randomized control trial: n=32 in the culturally adapted FCU-L Online (e.g., deep adaptation), n=32 in the FCU Online in Spanish without adaptation (e.g., surface level adaptation), and n= 32 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, 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.

Detailed description: In this study the investigators propose the following specific aims:

1. Employ community perspectives to adapt and maximize feasibility, acceptability, and adoption of the online Spanish-speaking version of Family Check-Up among Latinx families. A group of 12 parents of middle school youth (n=6) and stakeholders, including promotores (n=6), will meet monthly in the first year to guide user-informed adaptations that incorporate Latinx community perspectives into the content and delivery processes.
2. Develop a adapted version of Family Check-Up Online for Latinx families (FCU-L Online). Adapt current modules and develop two community responsive modules to address key issues identified by parents and stakeholders. Iterative usability feedback with an additional set of Spanish-speaking parents and stakeholders (N=12) will inform development in two Plan-Do-Study-Act (PDSA) cycles, consistent with best practices designed to adapt interventions in community settings. Additionally, adaptations to the implementation process using PDSA cycles will be made to support delivery by promotores.
3. Conduct a Hybrid 1 pilot study to evaluate the feasibility, acceptability, adoption, and potential effectiveness of FCU-L Online delivered by promotores, focusing on parenting practices as the mechanism of action. We will randomize 96 Spanish-speaking Latinx families with a youth aged 11-14 years to the adapted intervention delivered by promotores, the Spanish FCU Online without adaptation delivered by the research team, or a wait-list control.

Goal 1: Assess feasibility, acceptability, and adoption of the adapted FCU Online with new content (e.g., how the past affects parenting, developing cultural strength) and implementation strategies: surveys (N=96; e.g., acceptability, socialization) and interviews with a subset of parents (N=6) and promotores (N=6).

Goal 2: Evaluate the potential effectiveness of the adapted FCU Online on the primary outcomes, parenting practices (e.g., parenting efficacy, positive parenting, socialization) and explore effects on youth outcomes (e.g., substance use/intent and externalizing behavior).

Eligibility criteria: 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

Primary outcomes:
measure: Telehealth Usability Questionnaire
timeFrame: immediately after the intervention
measure: Consumer Satisfaction Questionnaire
timeFrame: immediately after the intervention
measure: Parenting Sense of Competency
timeFrame: baseline, immediately after the intervention, 3-month follow-up
measure: Latino Immigration Family Socialization Scale
timeFrame: baseline, immediately after the intervention, 3-month follow-up
measure: Adaptation of Parenting Young Children
timeFrame: baseline, immediately after the intervention, 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Oregon
name: Jennifer L. Doty, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauricio AM, Hails KA, Caruthers AS, Connell AM, Stormshak EA. Family Check-Up Online: Effects of a Virtual Randomized Trial on Parent Stress, Parenting, and Child Outcomes in Early Adolescence. Prev Sci. 2024 Sep 24. doi: 10.1007/s11121-024-01725-3. Online ahead of print.
citation: Stormshak EA, Seeley JR, Caruthers AS, Cardenas L, Moore KJ, Tyler MS, Fleming CM, Gau J, Danaher B. Evaluating the efficacy of the Family Check-Up Online: A school-based, eHealth model for the prevention of problem behavior during the middle school years. Dev Psychopathol. 2019 Dec;31(5):1873-1886. doi: 10.1017/S0954579419000907.