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Substance Use (Drugs, Alcohol)NCT07025083

Adaptation of the Family Check-Up Online

A study testing Adapted Family Check-Up Online and Original Family Check-Up Online in people with Substance Use (Drugs, Alcohol), run by University of Oregon at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Substance Use (Drugs, Alcohol)
What is being tested?
Adapted Family Check-Up Online and Original Family Check-Up Online
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteUnited States
Study dates
19 Dec 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

None listed.

Who cannot join

  • having low concerns on the Positive Family Support screener

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jennifer L. Doty, PhD contact

541-346-7545

jendoty@uoregon.edu

Anne-Marie M Mauricio, PhD contact

541-346-3630

amariem@uoregon.edu

United States1 site, 1 recruiting
  • University of Oregon

    Eugene, Oregon, 97403

    Jennifer Doty, PhD, 541-346-7545, jendoty@uoregon.edu

    Anne Marie Mauricio, PhD, (541) 346-3630, amariem@uoregon.edu

    Recruiting

Other trials in United States

About this study

Official title: Adaptation of Family Check-Up Online in the Latinx Community to Reduce Youth Substance Use

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.

Read the 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 108 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=108; 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).

Being tested
Adapted Family Check-Up Online, Original Family Check-Up Online
Keywords
adolescence, parenting, adaptation, family, substance use intent
Medical subject headings
Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adapted Family Check-Up OnlineBehavioural

    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 OnlineBehavioural

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

Study groups in NCT07025083
Study groupRoleWhat they receive
Family Check-Up Online Adapted for Latinx FamiliesExperimentalIn this arm, participants will receive the Family Check-Up Online adapted for Latinx families plus telehealth support from a promotore de salud.
Receives: Behavioral: Adapted Family Check-Up Online
Original Family Check-Up OnlineExperimentalIn this arm, participants will receive the original Family Check-Up online in Spanish.
Receives: Behavioral: Original Family Check-Up Online
Waitlist ControlNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Telehealth Usability Questionnaire

    We will use the Telehealth Usability Questionnaire(TUQ) to assess the quality of the program's technology interface and telehealth interaction. TUQ includes 21 items and covers five domains of telehealth system usability: usefulness (3 items; e.g., "FCU Online improves my access to health and preventative services"), ease of use and learnability (3 items; e.g., "It was simple to use this system"), interface quality (4 items; e.g., "The way I interact with this system is pleasant"), interaction quality (4 items; e.g., "I could easily talk to the coach using the telehealth system"), reliability (3 items; e.g., "Whenever I made a mistake using the system, I could recover easily and quickly"), and satisfaction and future use (4 items; e.g., "I feel comfortable communicating with the coach using the telehealth system"). All TUQ subscales have shown good internal consistency (Cronbach's αs > 0.8) and have been validated in Spanish.

    Measured: 3 months

  2. Consumer Satisfaction Questionnaire

    Consumer satisfaction will be measured using an adapted version of a measure that has been used in other brief motivational interviewing interventions (Stormshak et al., 2005). Participants will reflect and report on their perceived quality of the modules they acccess and home practice. At the end of the program, participants will receive the adapted consumer satisfaction questionnaire to report their satisfaction.

    Measured: 3 months

  3. Parenting Sense of Competency

    The Parenting Sense of Competency Scale (PSOC) will be used to measure parent efficacy. PSOC is a 19-item self-report measure that asks parents to what extent they agree or disagree with the statements regarding their parenting. PSOC has two subscales, including parent Self-efficacy (e.g., "Even though being a parent could be rewarding, I am frustrated while my child is at his/her present age.") and parent satisfaction (e.g., "I would make a good role model for new parents who needed to learn what it takes to be a good parent."). PSOC has overall good internal consistency (Cronbach's alpha = 0.82), and has been used with Spanish speaking parents. Parents respond on a 6-point Likert scale (1 = strongly agree to 6 = strongly disagree).

    Measured: baseline, 3 months, 6 months

  4. Latino Immigration Family Socialization Scale

    Socialization will be measured by the Latino Immigrant Family Socialization Scale (LIFS). LIFS is a 27-item self-report measure that contains six subscales, including adapt (5 items; e.g., "Encourage TC to learn to live with discrimination"), advocate (4 items; e.g., "Tell TC to seek help when he or she is discriminated"), cultural socialization (5 items; e.g., "Talk to TC about his or her roots and heritage"), educate about nativity and documentation (5 items; e.g., "Talk to TC about differences in rights based on immigration status"), value diversity (5 items; e.g., "Talk to TC about differences in cultures"), and promote mistrust (5 items; e.g., "Advice TC to be careful of people who are members of other racial or ethnic groups"). For each item, parents report how often they use these strategies on a 5-point Likert scale (1 = never to 5 = always). LIFS has been validated and shown acceptable internal consistencies (Cronbach's alphas > 0.70).

    Measured: baseline, 3 months, 6 months

  5. Adaptation of Parenting Young Children

    The Parenting Young Children Measure, which has been used with middle school children, will be used to measure support of good behavior (e.g., "Notice and praise your child's good behavior?"), setting limits (e.g., "Stick to your rules and not change your mind?"), and proactive parenting (e.g., "Give reasons for your requests?"). Each scale had 7 items, and parents self report using a Likert scale from 1 (not at all) to 7 (most of the time). These three scales have been validated, and these subscales have shown good internal consistency (Cronbach's alphas ranged from 0.79 to 0.85. This has been translated into Spanish in prior FCU studies.

    Measured: baseline, 3 months, 6 months

Secondary outcomes (2)
  1. Strengths and Difficulties Questionnaire

    The Strengths and Difficulties Questionnaire (SDQ) is a brief behavioral screening tool used to assess emotional and social well-being in children and adolescents. It evaluates five key areas-emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship issues, and prosocial behavior-providing a balanced view of both strengths and challenges. This measure will identify areas where the intervention has improved internalizing and externalizing behaviors.

    Measured: baseline, 3 months, 6 months

  2. CRAFFT

    The CRAFFT is well-used adolescent substance use screener for adolescents 12-21 for clinical use. Example items include, "Do you ever use drugs or alcohol while you are by yourself (alone)?" and "Have you ever gotten in trouble while you were using drugs and alcohol?" The CRAFFT has been shown to predict DSM-5 substance use disorders among adolescents. Chronbach's alpha was α = .79 and the screener has been validated in Spanish.

    Measured: baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start19 Dec 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025083
Sponsor's protocol ID
33365
Other IDs
1R34DA061150-01
Status last verified
May 2026
First submitted
6 May 2025
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: External researchers will have access to de-identified, individual-level data, and members of the general public will have access to metadata, descriptive data, and summary data. External researcher requests for individual-level data must be accompanied by a signed Data Use Agreement, and researchers must document that they are working under an institution with a Federal Wide Assurance (FWA). University of Oregon Information Services staff will develop and maintain the enclave to host and provide access to de-identified study data. The data enclave will be accessible to qualified researchers through a web portal that has capabilities to send and receive data by using encrypted secure transmission protocols.

Publications

  • 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. 2026 Jan;27(1):119-130. doi: 10.1007/s11121-024-01725-3. Epub 2024 Sep 24.

    PubMed 39316242
  • 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.

    PubMed 31407644

Questions about this trial

What is this clinical trial studying?

A study testing Adapted Family Check-Up Online and Original Family Check-Up Online in people with Substance Use (Drugs, Alcohol), run by University of Oregon at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer L. Doty, PhD (541-346-7545, jendoty@uoregon.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Telehealth Usability Questionnaire (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07025083, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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