An interventional study of Adapted Family Check-Up Online and Original Family Check-Up Online in Substance Use (Drugs, Alcohol), sponsored by University of Oregon. Recruiting at 1 site in United States. Open to participants aged 11 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by University of Oregon · Not applicable, Interventional, and Prevention
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Among 11 studies in Substance-Related Disorders by University of Oregon — 4 open to participants now, 4 under way, none of them phase 3. Substance-Related Disorders · University of Oregon.
Among the 11 studies in Substance-Related Disorders by University of Oregon, this one is the 7th largest by planned enrollment, is the only one that started in 2025, is one of 11 with no phase, and was the 10th registered.
2,241 studies on the registry are indexed under Substance-Related Disorders; 410 are open to participants now.
Browse Substance-Related Disorders studies →4 of the 11 studies in Substance-Related Disorders by University of Oregon are open now, in 1 country. Recruiting first, the newest first:
University of Oregon · Sites in United States
Ages 18+
University of Oregon · Sites in United States
Ages 18–24
University of Oregon · Sites in United States
Ages up to 50
By country, each count listing its studies:
Of the 265 Substance-Related Disorders studies recruiting now, 130 (49%) set no upper age limit and 117 (44%) stop at 75 or younger; 55 take children under 18; 89 take healthy volunteers.
This study: 11 Years to 14 Years · all sexes · healthy volunteers too.
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11 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2025.
This study's planned enrollment of 108 is close to the median of 108 across 1,843 interventional studies indexed under Substance-Related Disorders.
Median enrollment 180 across the 11 interventional studies. Of the 7 that completed or were terminated, 2 (29%) have results posted.
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University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.
2 of the studies in Substance-Related Disorders by University of Oregon that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07025083University of OregonAdaptation of the Family Check-Up Online | 2026-12-31 |
| NCT05684094University of OregonMechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function | 2027-02-28 |
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Among the 11 studies in Substance-Related Disorders by University of Oregon, from their registry updates:
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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.
In this study the investigators propose the following specific aims:
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).
Parent Inclusion Criteria:
Youth Inclusion Criteria:
Exclusion Criteria:
In this arm, participants will receive the Family Check-Up Online adapted for Latinx families plus telehealth support from a promotore de salud.
Behavioral: Adapted Family Check-Up Online
In this arm, participants will receive the original Family Check-Up online in Spanish.
Behavioral: Original Family Check-Up Online
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.
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.
This version is the original Family Check Up Online translated into Spanish without the adaptions. This represents a surface-level adaptation.
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.
Time frame: 3 months
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.
Time frame: 3 months
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).
Time frame: baseline, 3 months, 6 months
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).
Time frame: baseline, 3 months, 6 months
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.
Time frame: baseline, 3 months, 6 months
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.
Time frame: baseline, 3 months, 6 months
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.
Time frame: baseline, 3 months, 6 months
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Individual-level data will be released 12 months after the final participant has completed a given wave of data collection. This will allow time for data cleaning, and also provides a brief window for the investigative team to analyze and publish key findings prior to sharing the data, but still makes the data available to external researchers in a timely manner. After the grant award ends, if no additional external support is available to provide access to the data, the investigators will partner with the University of Oregon Libraries to host the data enclave and provide access to the data in perpetuity.
Access criteria: External researcher requests for de-identified 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). If no additional external support is available to provide access to the data, we will partner with the University of Oregon Libraries to host the data enclave and provide access to the data.
Data sharing details ↗ · researchguides.uoregon.edu
Started Dec 2025 (actual). Primary completion is estimated for Dec 2026, 12 months after the start.
Of 814 non-industry interventional studies with no phase under Substance-Related Disorders, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's planned 12 months is below that.
Counting every sponsor, half of 854 studies reached it within 34 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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