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Control Condition(LYFE-III)NCT07761052

The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families

A study testing Parenting Intervention in people with Control Condition and Parent, run by Texas A&M University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The objective of this study is to harness digital technology to bring to scale a culturally adapted and evidence-based parenting intervention for Latinos (Nuestras Familias: Andando Entre Culturas). Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Control Condition, Parent
What is being tested?
Parenting Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
No sites listed yet
Study dates
Sep 2026to 31 Jul 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 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The family identifies as Latino or Hispanic.
  • The family includes a child in the sixth or seventh grade.
  • The child is newly enrolled in or has recently begun receiving services through Breakthrough Central Texas.
  • At least one parent or primary caregiver speaks Spanish.
  • A parent or primary caregiver and the participating child are willing to complete study assessments.
  • The parent or primary caregiver agrees that the family may be randomly assigned to either the LYFE-III intervention group or the services-as-usual group.
  • The parent or primary caregiver is willing to complete the online parenting program if assigned to the LYFE-III intervention group.
  • The parent or legal guardian is willing to provide informed consent, and the child is willing to provide assent.

Who cannot join

  • The parent or primary caregiver is currently participating in another parenting education or parent-training program.
  • A participating parent or child has an active, severe mental health condition, such as schizophrenia or another psychotic disorder, that would make participation in a preventive parenting program inappropriate.
  • A participating parent or child has mental health or substance-use needs that, after review by a study psychologist, require a higher level of care than the LYFE-III prevention program provides.
  • The parent or child is unable or unwilling to complete the study procedures or participate in the assigned study condition.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Cory L Cobb, PhD contact

501-749-3382

cory.cobb@tamu.edu

Lawrence Watkins, MS contact

832-364-2600

lgwatkins@tamu.edu

About this study

The objective of this study is to harness digital technology to bring to scale a culturally adapted and evidence-based parenting intervention for Latinos (Nuestras Familias: Andando Entre Culturas). The Latino Youth and Family Empowerment - III study (LYFE-III) proposed here will adapt, scale, and evaluate the efficacy of an online version of Nuestras Familias with Latino parents and youth in a randomized controlled trial (RCT). The specific aims are as follows:

Aim 1. To adapt the Nuestras Familias intervention to an online format that can be widely accessed by underserved Latino families. This process includes intervention refinement, enhancing efficiency, and manualization of intervention content

Aim 2. Conduct a small randomized controlled pilot trial to (a) test the online program's promise while evaluating changes in target mechanisms of action (i.e., parenting practices) and their subsequent effects on youth mental health outcomes; and (b) to evaluate the feasibility, appropriateness, and acceptability of the online version of the Nuestras Familias intervention.

Read the detailed description

The Latino Youth and Family Empowerment Study-III (LYFE-III) is designed to adapt and pilot test Nuestras Familias: Andando Entre Culturas, a culturally adapted, evidence-based parenting intervention for Latino families. Nuestras Familias integrates principles from parent management training, social learning theory, and ecodevelopmental theory. The program is intended to strengthen parenting practices that may protect against mental and behavioral health problems among Latino youth.

The study consists of two stages. During the first stage, the existing intervention will be adapted from a group-based, in-person format to a self-guided online format. The digital program will preserve the intervention's core parenting components while making the content more accessible and reducing the time and logistical demands associated with attending in-person sessions. Latino parents and community stakeholders will participate in an iterative user-centered refinement process to evaluate the program's cultural relevance, usability, clarity, and technological accessibility. Feedback from successive focus groups will be used to revise and finalize the digital intervention and its accompanying online manual.

The digital intervention will address parental involvement, monitoring, positive reinforcement and skill encouragement, appropriate and consistent discipline, family communication, and family problem solving. It will also address experiences relevant to Latino families, including familismo, respeto, parent-youth differences in acculturation, family and gender roles, language barriers, discrimination, and structural barriers affecting families. Program content will include brief presentations, demonstrations and video-based role plays, interactive activities, summaries of key concepts, and opportunities for parents to practice parenting strategies at home. Parents will proceed through the program sequentially and will receive access to new content on a weekly basis. An online discussion forum, periodic program-related messages, progress tracking, and contact with the research team will be used to support engagement.

During the second stage, the refined intervention will be evaluated in a randomized pilot trial. Participating families will be randomly assigned to receive either the LYFE-III online parenting intervention or services as usual through the collaborating community organization. Families assigned to services as usual will retain access to the organization's customary resources but will not receive LYFE-III during the trial. They will be offered access to the intervention after completion of study activities.

Parents and youth will complete online assessments before the intervention, at the end of the approximately four-month intervention period, and three months after the intervention ends. The pilot is intended to evaluate the feasibility, acceptability, appropriateness, engagement, and initial promise of delivering the culturally adapted intervention online. It will also estimate intervention-related changes in parenting practices and youth mental and behavioral health and examine whether changes in parenting practices are associated with subsequent changes in youth outcomes. Findings will be used to refine the intervention and its implementation procedures and to inform a future, larger-scale effectiveness trial.

Being tested
Parenting Intervention

What participants receive

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

  • Parenting InterventionBehavioural

    LYFE-III is a culturally adapted, self-guided online parenting intervention delivered to parents of Latino youth over approximately four months. Parents receive sequential access to one digital module per week. Modules address parental involvement, monitoring, positive reinforcement and skill encouragement, consistent discipline, family communication, problem solving, and culturally relevant experiences such as familismo, respeto, parent-youth differences in acculturation, discrimination, and structural barriers. Modules include brief presentations, video demonstrations and role plays, interactive activities, summaries, and home-practice exercises. Engagement supports include weekly program-related messages, progress tracking, periodic contact from the research team, and an online discussion forum where parents can discuss their practice experiences and receive feedback.

Study groups in NCT07761052
Study groupRoleWhat they receive
ParentingExperimentalFamilies assigned to this arm will receive the LYFE-III digital version of Nuestras Familias: Andando Entre Culturas. Parents will complete sequential, self-guided online modules addressing parental involvement, monitoring, positive reinforcement and skill encouragement, consistent discipline, family communication, problem solving, and culturally relevant experiences affecting Latino families. The program includes presentations, video demonstrations, interactive activities, home-practice exercises, weekly messages, progress tracking, and an online discussion forum. Families may also receive services ordinarily available through the collaborating community organization.
Receives: Behavioral: Parenting Intervention
ControlNo interventionFamilies assigned to this arm will not receive the LYFE-III intervention during the trial. They may continue to access services ordinarily available through the collaborating community organization. Use of these services will be monitored during the study. Families in this arm will be offered access to the LYFE-III online parenting intervention after completing study activities.

What is being measured

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

  1. Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention

    The 9-item General Parenting Scale assesses parents' perceived ability to use effective parenting practices, including communication, problem solving, encouragement, limit setting, monitoring, positive involvement, consistent discipline, and implementation of consequences. Each item is scored from 1 to 5. The mean score ranges from 1 to 5, with higher scores indicating more effective parenting practices.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  2. Mean Acceptability of Intervention Measure Score Immediately Post-Intervention

    The 4-item Acceptability of Intervention Measure assesses the extent to which participants perceive LYFE-III as agreeable, appealing, and satisfactory. Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged. Mean scores range from 1 to 5, with higher scores indicating greater intervention acceptability. This outcome is assessed among participants assigned to the LYFE-III intervention.

    Measured: Immediately after completion of the approximately 3-week intervention

  3. Mean Intervention Appropriateness Measure Score Immediately Post-Intervention

    The 4-item Intervention Appropriateness Measure assesses the perceived fit, relevance, suitability, and applicability of LYFE-III. Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged. Mean scores range from 1 to 5, with higher scores indicating greater perceived appropriateness. This outcome is assessed among participants assigned to the LYFE-III intervention.

    Measured: Immediately after completion of the approximately 3-week intervention

  4. Mean Feasibility of Intervention Measure Score Immediately Post-Intervention

    The 4-item Feasibility of Intervention Measure assesses the extent to which participants perceive LYFE-III as implementable, possible, doable, and easy to use. Items are scored from 1 (completely disagree) to 5 (completely agree), and responses are averaged. Mean scores range from 1 to 5, with higher scores indicating greater perceived feasibility. This outcome is assessed among participants assigned to the LYFE-III intervention.

    Measured: Immediately after completion of the approximately 3-week intervention

Secondary outcomes (20)
  1. Change in Parent-Reported General Parenting Scale Mean Score From Baseline to 3-Month Follow-Up

    The 9-item General Parenting Scale assesses parents' perceived ability to use effective parenting practices, including communication, problem solving, encouragement, limit setting, monitoring, positive involvement, consistent discipline, and implementation of consequences. Each item is scored from 1 to 5. The mean score ranges from 1 to 5, with higher scores indicating more effective parenting practices.

    Measured: Baseline and 3 months after intervention completion

  2. Change in Youth-Reported Depressive Symptoms From Baseline to Immediately Post-Intervention

    Youth depressive symptoms are assessed with the 9-item Patient Health Questionnaire Modified for Teens. Each item is scored from 0 (not at all) to 3 (nearly every day) and summed. Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  3. Change in Youth-Reported Anxiety Symptoms From Baseline to Immediately Post-Intervention

    Youth anxiety symptoms are assessed with the 7-item Generalized Anxiety Disorder scale. Each item is scored from 0 (not at all) to 3 (nearly every day) and summed. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  4. Change in Youth-Reported Anxiety Symptoms From Baseline to 3-Month Follow-Up

    Youth anxiety symptoms are assessed with the 7-item Generalized Anxiety Disorder scale. Each item is scored from 0 (not at all) to 3 (nearly every day) and summed. Total scores range from 0 to 21, with higher scores indicating greater anxiety symptom severity.

    Measured: Baseline and 3 months after intervention completion

  5. Change in Youth-Reported Externalizing Problems From Baseline to Immediately Post-Intervention

    Externalizing problems are assessed with the 10-item Youth Externalizing Problems Screener. Items assess behaviors such as anger, arguing, rule breaking, aggression, impulsivity, inattention, and failure to follow directions. Each item is scored from 1 (almost never) to 4 (almost always) and summed. Total scores range from 10 to 40, with higher scores indicating more frequent externalizing problems.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  6. Change in Youth-Reported Externalizing Problems From Baseline to 3-Month Follow-Up

    Externalizing problems are assessed with the 10-item Youth Externalizing Problems Screener. Items assess behaviors such as anger, arguing, rule breaking, aggression, impulsivity, inattention, and failure to follow directions. Each item is scored from 1 (almost never) to 4 (almost always) and summed. Total scores range from 10 to 40, with higher scores indicating more frequent externalizing problems.

    Measured: Baseline and 3 months after intervention completion

  7. Change in Parent-Reported Youth Anxiety and Depression From Baseline to Immediately Post-Intervention

    Parent-reported youth anxiety and depressive symptoms are assessed with the 25-item Revised Child Anxiety and Depression Scale-Parent Version. Each item is scored from 0 (never) to 3 (always). The total raw score ranges from 0 to 75, with higher scores indicating greater combined anxiety and depressive symptom severity. Anxiety and depression subscale scores may also be calculated.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  8. Change in Parent-Reported Youth Anxiety and Depression From Baseline to 3-Month Follow-Up

    Parent-reported youth anxiety and depressive symptoms are assessed with the 25-item Revised Child Anxiety and Depression Scale-Parent Version. Each item is scored from 0 (never) to 3 (always). The total raw score ranges from 0 to 75, with higher scores indicating greater combined anxiety and depressive symptom severity. Anxiety and depression subscale scores may also be calculated.

    Measured: Baseline and 3 months after intervention completion

  9. Percentage of Participants Completing All Assigned LYFE-III Intervention Modules

    Intervention completion is defined as completing all required LYFE-III online modules. The outcome is calculated as the number of participants assigned to LYFE-III who complete all required modules divided by the total number assigned to LYFE-III, multiplied by 100. Percentages range from 0% to 100%, with higher percentages indicating greater intervention completion.

    Measured: From intervention initiation through completion of the approximately 3-week intervention

  10. Percentage of Enrolled Families Completing the 3-Month Follow-Up Assessment

    Retention is calculated as the number of enrolled families who complete the 3-month post-intervention assessment divided by the total number of enrolled families, multiplied by 100. Percentages range from 0% to 100%, with higher percentages indicating greater study retention.

    Measured: From enrollment through 3 months after intervention completion

  11. Change in the Percentage of Youth Reporting Any Substance Use From Baseline to Immediately Post-Intervention

    Youth substance use is assessed with the Oregon Social Learning Center Youth Substance Use Questionnaire. Any substance use is defined as self-reported use of one or more assessed substances, including alcohol, tobacco, marijuana, or another drug, during the questionnaire's specified recall period. The outcome is the percentage of youth meeting this criterion. Percentages range from 0% to 100%, with higher percentages indicating more substance use.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  12. Change in the Percentage of Youth Reporting Any Substance Use From Baseline to 3-Month Follow-Up

    Youth substance use is assessed with the Oregon Social Learning Center Youth Substance Use Questionnaire. Any substance use is defined as self-reported use of one or more assessed substances, including alcohol, tobacco, marijuana, or another drug, during the questionnaire's specified recall period. The outcome is the percentage of youth meeting this criterion. Percentages range from 0% to 100%, with higher percentages indicating more substance use.

    Measured: Baseline and 3 months after intervention completion

  13. Change in Youth-Reported Likelihood of Future Substance Use From Baseline to Immediately Post-Intervention

    The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' perceived likelihood of using alcohol, tobacco, marijuana, or other drugs in the future. Item responses will be averaged to calculate a mean likelihood-of-use score. Higher scores indicate a greater perceived likelihood of future substance use.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  14. Change in Youth-Reported Likelihood of Future Substance Use From Baseline to 3-Month Follow-Up

    The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' perceived likelihood of using alcohol, tobacco, marijuana, or other drugs in the future. Item responses will be averaged to calculate a mean likelihood-of-use score. Higher scores indicate a greater perceived likelihood of future substance use.

    Measured: Baseline and 3 months after intervention completion

  15. Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to Immediately Post-Intervention

    The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' intentions to refuse opportunities to use alcohol, tobacco, marijuana, or other drugs. Item responses will be averaged to calculate a mean refusal-intention score. Higher scores indicate stronger intentions to refuse substance use.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  16. Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to 3-Month Follow-Up

    The Oregon Social Learning Center Youth Substance Use Questionnaire assesses youths' intentions to refuse opportunities to use alcohol, tobacco, marijuana, or other drugs. Item responses will be averaged to calculate a mean refusal-intention score. Higher scores indicate stronger intentions to refuse substance use.

    Measured: Baseline and 3 months after intervention completion

  17. Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to Immediately Post-Intervention

    Substance-related risk is assessed using the parent-report version of the CRAFFT Screening Interview. The six CRAFFT items assess riding in a vehicle with an impaired driver, using substances to relax or fit in, using substances alone, forgetting events while using substances, concerns expressed by family or friends, and substance-related trouble. Each "yes" response receives 1 point. Total scores range from 0 to 6, with higher scores indicating greater substance-related risk.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  18. Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to 3-Month Follow-Up

    Substance-related risk is assessed using the parent-report version of the CRAFFT Screening Interview. The six CRAFFT items assess riding in a vehicle with an impaired driver, using substances to relax or fit in, using substances alone, forgetting events while using substances, concerns expressed by family or friends, and substance-related trouble. Each "yes" response receives 1 point. Total scores range from 0 to 6, with higher scores indicating greater substance-related risk.

    Measured: Baseline and 3 months after intervention completion

  19. Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to Immediately Post-Intervention

    Current tobacco use is assessed using the Consumer Self-Report Tobacco Assessment. Current use is defined as reported current use of at least one assessed tobacco product, including cigarettes, electronic cigarettes or vaping products, pipes, cigars, or chewing tobacco. The outcome is the percentage of youth meeting this criterion. Percentages range from 0% to 100%, with higher percentages indicating more current tobacco use.

    Measured: Baseline and immediately after completion of the approximately 3-week intervention

  20. Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to 3-Month Follow-Up

    Current tobacco use is assessed using the Consumer Self-Report Tobacco Assessment. Current use is defined as reported current use of at least one assessed tobacco product, including cigarettes, electronic cigarettes or vaping products, pipes, cigars, or chewing tobacco. The outcome is the percentage of youth meeting this criterion. Percentages range from 0% to 100%, with higher percentages indicating more current tobacco use.

    Measured: Baseline and 3 months after intervention completion

Timeline

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

  1. First posted12 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07761052
Sponsor's protocol ID
STUDY2025-1134
Other IDs
5R34MH134935
Acronym
(LYFE-III)
Status last verified
Aug 2026
First submitted
7 Aug 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: This NIMH-funded study will generate individual-participant research data, and NIH expects investigators to share scientific data according to their approved plan. "Yes" does not mean posting identifiable or unrestricted data publicly. You can share deidentified data through a controlled-access repository or approved request process, with safeguards for minors and sensitive information such as immigration status.

Questions about this trial

What is this clinical trial studying?

A study testing Parenting Intervention in people with Control Condition and Parent, run by Texas A&M University.

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 8 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

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 Cory L Cobb, PhD (501-749-3382, cory.cobb@tamu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention (time frame: Baseline and immediately after completion of the approximately 3-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 13 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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