- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07025083
- Original Trial
Adaptation of the Family Check-Up Online
Adaptation of Family Check-Up Online in the Latinx Community to Reduce Youth Substance Use
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In this study the investigators propose the following specific aims:
- 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.
- 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.
- 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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer L. Doty, PhD
- Phone Number: 541-346-7545
- Email: jendoty@uoregon.edu
Study Contact Backup
- Name: Anne-Marie M Mauricio, PhD
- Phone Number: 541-346-3630
- Email: amariem@uoregon.edu
Study Locations
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Oregon
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Eugene, Oregon, United States, 97403
- Recruiting
- University of Oregon
-
Contact:
- Jennifer Doty, PhD
- Phone Number: 541-346-7545
- Email: jendoty@uoregon.edu
-
Contact:
- Anne Marie Mauricio, PhD
- Phone Number: (541) 346-3630
- Email: amariem@uoregon.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
Experimental: Original Family Check-Up Online
In this arm, participants will receive the original Family Check-Up online in Spanish.
|
This version is the original Family Check Up Online translated into Spanish without the adaptions.
This represents a surface-level adaptation.
|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Telehealth Usability Questionnaire
Time Frame: 3 months
|
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.
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3 months
|
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Consumer Satisfaction Questionnaire
Time Frame: 3 months
|
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.
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3 months
|
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Parenting Sense of Competency
Time Frame: baseline, 3 months, 6 months
|
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).
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baseline, 3 months, 6 months
|
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Latino Immigration Family Socialization Scale
Time Frame: baseline, 3 months, 6 months
|
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).
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baseline, 3 months, 6 months
|
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Adaptation of Parenting Young Children
Time Frame: baseline, 3 months, 6 months
|
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.
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baseline, 3 months, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Strengths and Difficulties Questionnaire
Time Frame: baseline, 3 months, 6 months
|
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.
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baseline, 3 months, 6 months
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CRAFFT
Time Frame: baseline, 3 months, 6 months
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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.
|
baseline, 3 months, 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jennifer L. Doty, PhD, University of Oregon
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 33365
- 1R34DA061150-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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