The Latino Youth and Family Empowerment Study - III (LYFE-III): Bringing to Scale a Culturally-Adapted and Evidence-Based Intervention for Latino Families ((LYFE-III))
2026年8月11日 更新者：Cory Cobb、Texas A&M University
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.
調査の概要
状態
状態
まだ募集していません
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
介入
入学 (推定)
入学
200
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
研究連絡先
- 名前：Cory L Cobb, PhD
- 電話番号：501-749-3382
- メール：cory.cobb@tamu.edu
研究連絡先のバックアップ
- 名前：Lawrence Watkins, MS
- 電話番号：832-364-2600
- メール：lgwatkins@tamu.edu
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：Parenting
Families 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.
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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.
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介入なし：Control
Families 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.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Parent-Reported and Youth-Reported General Parenting Scale Mean Score From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week intervention
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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.
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Baseline and immediately after completion of the approximately 3-week intervention
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Mean Acceptability of Intervention Measure Score Immediately Post-Intervention
時間枠：Immediately after completion of the approximately 3-week intervention
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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.
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Immediately after completion of the approximately 3-week intervention
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Mean Intervention Appropriateness Measure Score Immediately Post-Intervention
時間枠：Immediately after completion of the approximately 3-week intervention
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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.
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Immediately after completion of the approximately 3-week intervention
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Mean Feasibility of Intervention Measure Score Immediately Post-Intervention
時間枠：Immediately after completion of the approximately 3-week intervention
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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.
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Immediately after completion of the approximately 3-week intervention
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Parent-Reported General Parenting Scale Mean Score From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
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Baseline and 3 months after intervention completion
|
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Change in Youth-Reported Depressive Symptoms From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
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Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in Youth-Reported Anxiety Symptoms From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Youth-Reported Anxiety Symptoms From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
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Baseline and 3 months after intervention completion
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Change in Youth-Reported Externalizing Problems From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week intervention
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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.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Youth-Reported Externalizing Problems From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
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Baseline and 3 months after intervention completion
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Change in Parent-Reported Youth Anxiety and Depression From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
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Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in Parent-Reported Youth Anxiety and Depression From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
|
Baseline and 3 months after intervention completion
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Percentage of Participants Completing All Assigned LYFE-III Intervention Modules
時間枠：From intervention initiation through completion of the approximately 3-week intervention
|
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.
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From intervention initiation through completion of the approximately 3-week intervention
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Percentage of Enrolled Families Completing the 3-Month Follow-Up Assessment
時間枠：From enrollment through 3 months after intervention completion
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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.
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From enrollment through 3 months after intervention completion
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Change in the Percentage of Youth Reporting Any Substance Use From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
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Change in the Percentage of Youth Reporting Any Substance Use From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
|
Baseline and 3 months after intervention completion
|
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Change in Youth-Reported Likelihood of Future Substance Use From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
|
Baseline and immediately after completion of the approximately 3-week intervention
|
|
Change in Youth-Reported Likelihood of Future Substance Use From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
|
Baseline and 3 months after intervention completion
|
|
Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week 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.
|
Baseline and immediately after completion of the approximately 3-week intervention
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Change in Youth-Reported Substance-Use Refusal Intentions From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
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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.
|
Baseline and 3 months after intervention completion
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Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week intervention
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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.
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Baseline and immediately after completion of the approximately 3-week intervention
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Change in Parent-Reported Youth CRAFFT Substance-Related Risk Score From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
|
Baseline and 3 months after intervention completion
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Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to Immediately Post-Intervention
時間枠：Baseline and immediately after completion of the approximately 3-week intervention
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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.
|
Baseline and immediately after completion of the approximately 3-week intervention
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Change in the Percentage of Youth Reported to Currently Use Tobacco From Baseline to 3-Month Follow-Up
時間枠：Baseline and 3 months after intervention completion
|
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.
|
Baseline and 3 months after intervention completion
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
研究開始
2026年9月1日
一次修了 (推定)
一次修了
2027年7月31日
研究の完了 (推定)
研究の完了
2027年7月31日
試験登録日
最初に提出
最初に提出
2026年8月7日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年8月7日
最初の投稿 (実際)
最初の投稿
2026年8月12日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年8月13日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年8月11日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- STUDY2025-1134
- 5R34MH134935 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD プランの説明
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.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
- CSR
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。