ClinicalTrials.gg
CompletedNCT05437081LEAUpdated Jun 29, 2022

A Family-Based Alcohol Preventive Intervention for Latino Emerging Adults

An interventional study of Latino Emerging Adults (LEA) in Binge Alcohol Consumption, Risk Behavior, Health and Driving Under the Influence, sponsored by University of Oregon. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-29.

Sponsored by University of Oregon · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Aug 2016, registered Nov 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The purpose of the proposed study was to develop a family-based drinking prevention intervention for Latino emerging adults (EAs) and Latino parents of EAs. Although drinking rates for Latinos are lower than those for Whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for Latinos, especially those 18-23 years old. The investigators developed a brief (4 session) intervention for each of EAs and parents focused on identity development and parent support for EAs, respectively.

Read the detailed description

The purpose of the proposed study was to develop a family-based drinking prevention intervention for Latino emerging adults (EAs) and Latino parents of EAs. The investigators specifically targeted EAs aged 18-23. Although drinking rates for Latinos are lower than those for Whites in terms of the prevalence of alcohol use, the consequences of alcohol use (e.g., drunk driving, unplanned/unprotected sex, alcohol-related injuries) appear to be more severe for Latinos, especially those 18-23 years old.

The intervention program included four sessions with emerging adults (EA) in a group setting, and four sessions with groups of parents of EAs. This dual-site project was developed in Oregon and Florida in three phases: (1) development of the intervention components; (2) initial pilot testing and focus group feedback (including modifying the intervention and revising the manuals); and (3) a randomized pilot study. The EA component was developed by integrating identity-based intervention strategies that have been used successfully with adolescents and EAs, ensuring that they are developmentally and culturally appropriate. The parenting component was developed by adapting efficacious parenting strategies used with adolescents so that the activities were developmentally and culturally appropriate for parents of EAs. As the pilot study launch coincided with the start of the COVID-19 pandemic, the investigators adapted the original in-person approaches for online delivery.

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Conditions studied

  • Binge Alcohol Consumption
  • Risk Behavior, Health
  • Driving Under the Influence
  • High-Risk Sex
  • Identity, Social
  • Parenting
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In context

Binge Drinking

71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.

This study's enrollment of 83 is below the median of 120 across 64 interventional studies indexed under Binge Drinking.

Browse Binge Drinking studies →

Lead sponsor

University of Oregon is the lead sponsor of 75 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Emerging adult criteria:

  • Between the ages of 18 and 23 years old upon recruitment
  • Identify as Latina/o, Hispanic, Chicana/o, or have been born or descended from a parent or grandparent from Mexico or another nation in Central or South America or the Spanish-speaking Caribbean
  • Intend to remain in the area for the four months following their recruitment into the study in order to participate in the intervention, if selected

Parent criteria:

  • Have a child between the ages of 18 and 23 years old
  • Identify as Latina/o, Hispanic, Chicana/o, or have been born or descended from a parent from Mexico, or a nation in Central or South America or the Spanish-speaking Caribbean
  • Speak and understand Spanish

Exclusion criteria

Exclusion Criteria:

Emerging adult criteria:

  • EAs are not themselves a parent or stepparent
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
83 participants (actual)

Study arms

  • Experimental
    EMERGE program

    Participants were randomly assigned to one of two conditions: intervention or control. Intervention participants engaged in a 4 session program named the EMERGE program focused on identity development (emerging adults) or support for emerging adults (parents). Control participants received referrals to community agencies for behavioral and mental health support as needed.

    Behavioral: Latino Emerging Adults (LEA)

  • No intervention
    Referral services as needed

    Participants were randomly assigned to one of two conditions: intervention or control. Control participants received services as usual.

Interventions

  • BehavioralLatino Emerging Adults (LEA)

    The LEA program involves two components, one for emerging adults (aged 18-23 years old) focused on identity development linked to cultural and familial strengths, and a parent component focused on support for emerging adult children. Each session is 4 sessions.

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What researchers measure

Primary outcomes

  1. Emerging Adult Self-Efficacy

    The Latino Emerging Adult (LEA) Self-Efficacy scale was designed to appraise Latino emerging adults' healthy identity formation and healthy behaviors. Participating emerging adults self-administered this online assessment twice during the study--at baseline, pre-intervention, and 3-4 months post-intervention. The scale includes 14 items (e.g., I feel confident that I can successfully tackle the challenges of becoming an adult; I draw on strengths from my family's cultural background to help me deal with the stress of becoming an adult; I use healthy activities to deal with stress; Mentors \[parents or other trusted adults\] are important in the life success of emerging adults). Answer choices include: 1-Strongly disagree; 2-Disagree; 3-Agree; 4-Strongly Agree. Higher scores indicate higher emerging adult self-efficacy. The Cronbach's alpha was .78. (Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult Self-Efficacy scale. University of Oregon.)

    Time frame: 3-4 months

  2. Parent-Emerging Adult Relationship Quality

    The Latino Emerging Adult (LEA) Parent-Emerging Adult Relationship Quality scale was designed by the research team. Participating emerging adults self-administered this online computer-based survey twice during the study--at baseline and approximately 3-4 months later, after the completion of the intervention program. The scale includes 6 items (e.g., Even though my parent can be annoying, I know that she/he is my best supporter; Even when I think that my parent is wrong, I understand where she/he is coming from). Answer choices include: 0-Not at all true; 1-Not really true; 2-Somewhat true; 3-Very true. Higher scores equal higher quality relationships as reported by emerging adults. The Cronbach's alpha was .82. (Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult Parent-Emerging Adult Relationship Quality scale. University of Oregon.)

    Time frame: 3-4 months

  3. Parent Trust in Emerging Adult Decision-Making

    The Latino Emerging Adult (LEA) Parent Trust in Emerging Adult Decision-Making scale was designed by the research team. Participating parents self-administered this online computer-based survey twice during the study--at baseline and approximately 3-4 months later, after the completion of the intervention program. The scale includes 6 items (e.g., I am confident that my emerging adult child will make the right choices in life; I'm afraid that my emerging adult child will not be able to figure out what to do in life; My emerging adult child knows what to do when s/he needs to make an important life decision). Answer choices include: 0-Not at all true; 1-Not really true; 2-Somewhat true; 3-Very true. Higher scores indicate higher parent-reported trust in emerging adult children's decision-making. The Cronbach's alpha was .77. (Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult (LEA) Parent Trust in Emerging Adult Decision-Making scale. University of Oregon.)

    Time frame: 3-4 months

  4. Parent support

    The Latino Emerging Adult (LEA) Parent Support scale was designed by the research team. Participating parents self-administered this online computer-based survey twice during the study--at baseline and approximately 3-4 months later, after the completion of the intervention program. The scale includes 8 items (e.g., Even if \[child's name\] doesn't listen to me one time, I still know that I can get through to him/her the next time; \[child's name\] comes to me and talks to me about important issues in his/her life; I generally know how to connect with or reach out to \[child's name\] when they need my support). Answer choices include: 1-Strongly disagree; 2-Disagree; 3-Agree; 4-Strongly Agree. Higher scores indicate higher parent support. The Cronbach's alpha was .82. (Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult (LEA) Parent Support scale. University of Oregon.)

    Time frame: 3-4 months

  5. Emerging adult alcohol consumption

    Three items from the University of Michigan's Monitoring the Future survey were used to appraise alcohol use (Johnston, L. D., O'Malley, P. M., Bachman, J. G., Schulenberg, J. E., \& Miech, R. A. (2015). Monitoring the Future national survey results on drug use, 1975-2014: Volume II, college students and adults ages 19-55.). Items include: 1. Have ever tried even a few sips of alcohol? Yes No (if no, skip to #3) 2. If YES: How old were you when you first tried at least a few sips of alcohol? _____ years old 3. During the last 3 months, what was the HIGHEST number of drinks that you drank in a single day?

    Time frame: 3-4 months

  6. Drinking-related risk behaviors

    Twelve items from the Monitoring the Future survey were used (Johnston, L. D., O'Malley, P. M., Bachman, J. G., Schulenberg, J. E., \& Miech, R. A. (2015). Monitoring the Future national survey results on drug use, 1975-2014: Volume II, college students and adults ages 19-55). Exemplar items include: During the last 3 months, about how many days did you drink until it affected your ability to make decisions?; How many times in the last 3 months did you use other drugs after you had been drinking?; and, In the past 3 months, how many times did you ride in a car when you knew the driver was drunk or high?

    Time frame: 3-4 months

  7. Drinking-related harm reduction behaviors

    The Latino Emerging Adult (LEA) Drinking-related Harm Reduction Behaviors scale was designed by the research team. Participating emerging adults self-administered this online survey twice during the study--at baseline and approximately 3-4 months later, after the completion of the intervention program. The scale includes 13 items (e.g., If one of my friends is really drunk, I make sure that person is safe; If I have been drinking too much I feel comfortable finding a ride home with a sober driver or finding a place to sleep; In my group of friends, if someone has been drinking too much we make sure that he/she doesn't drive). Answer choices include: 1-Strongly disagree; 2-Disagree; 3-Agree; 4-Strongly Agree. Higher scores indicate EAs practice more alcohol-related harm-reducing behaviors. The Cronbach's alpha was .93. (Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult (LEA) Drinking-related Harm Reduction Behaviors scale. University of Oregon.)

    Time frame: 3-4 months

  8. Emerging adult perceived stress

    Emerging adult participants respond in an online survey to the 10-item Perceived Stress Scale (PSS-10; Cohen, S. and Williamson, G. \[1988\]. Perceived stress in a probability sample of the United States. In S. Spacapan \& S. Oskamp \[Eds.\] The social psychology of health \[pp. 31-67\]. Sage Publications, Inc.). Answer choices range from Never = 0 to Very often = 4. Responses are summed with higher sum scores reflecting higher perceived stress. The Cronbach's alpha for emerging adults in this study was .82.

    Time frame: 3-4 months

  9. Parent perceived stress

    Parent participants respond in an online survey to the 10-item Perceived Stress Scale (PSS-10; Cohen, S. and Williamson, G. \[1988\]. Perceived stress in a probability sample of the United States. In S. Spacapan \& S. Oskamp \[Eds.\] The social psychology of health \[pp. 31-67\]. Sage Publications, Inc.). Answer choices range from Never = 0 to Very often = 4. Responses are summed with higher sum scores reflecting higher perceived stress.

    Time frame: 3-4 months

  10. Bicultural identity integration

    Sixteen items from the Bicultural Identity Integration Scale (BIIS-2) were used to capture variation in emerging adults' experiences of acculturation. (Huynh, Q. L., Benet-Martínez, V., \& Nguyen, A. M. D. \[2018\]. Measuring variations in bicultural identity across US ethnic and generational groups: Development and validation of the Bicultural Identity Integration Scale-Version 2 \[BIIS-2\]. Psychological Assessment, 30\[12\], 1581.). Exemplar items include: I feel part of a combined culture that is a mixture of Hispanic/Latino and American; I find it difficult to combine Hispanic/Latino and American cultures; I do not blend my Hispanic/Latino and American cultures. Answer choices range from 1 (strongly disagree) to 5 (Strongly agree). The scale taps cultural blendedness versus compartmentalization and cultural harmony versus conflict, and final scores are averages.

    Time frame: 3-4 months

  11. Emerging adult future orientation

    Ten items from the Steinberg et al. Future Orientation Scale were used (Steinberg L, Graham S, O'Brien L, Woolard J, Cauffman E, Banich M. \[2009\]. Age differences in future orientation and delay discounting. Child Development. Jan-Feb;80\[1\]:28-44.) The 10 items include question numbers 2, 3, 4, 5, 7, 9, 10, 12, 13, 15 across 4 sub-scales including Planning Ahead, Time Perspective, Anticipation of Future Consequences, and Anticipation of Future Consequences. All items are scored left to right on a scale of 1-4. Reverse score items 1, 3, 4, 6, 8, 11, and 14, so that higher scores indicate a stronger future orientation.

    Time frame: 3-4 months

  12. Parent hope for emerging adult child's future

    This 12 item scale appraises parents' hopes for their emerging adult children's future. Answer options range from 0-Not at all true to 3-Very true. Exemplar items include: It's important to me that (my child) continues her/his education after high school; It's important to me that (my child) graduates from college; I know what (my child's) goals are for her/his future; and I help (my child) make plans and take steps towards her/his goals for the future. Citation: Center for Equity Promotion. \[2019\]. Latino Emerging Adult (LEA) Parent Hope for Emerging Adult Future scale. University of Oregon.)

    Time frame: 3-4 months

  13. American identity integration

    Seven items were used from the American Identity Measure (Schwartz et al \[2012\]. The American Identity Measure: Development and validation across ethnic subgroup and immigrant generation. Identity: An International Journal of Theory and Research, 12\[2\], 93-128.). Exemplar items include: I am happy that I am an American; I have a strong sense of belonging to the United States. Answer choices range from 1 (strongly disagree) to 5 (Strongly agree). Higher scores indicate higher American identity affirmation.

    Time frame: 3-4 months

Secondary outcomes

  1. Emerging adult acculturative stress

    Items from the Multidimensional Acculturative Stress Inventory for Adults of Mexican Origin (MASI) were used (Rodriguez et al. \[2002\]. Development of the Multidimensional Acculturative Stress Inventory for Adults of Mexican Origin. Psychological Assessment, 14\[4\], 451-461.) The MASI is a 36-item stress measure that assesses acculturative stress among persons of Mexican origin living in the United States;10 items were selected that are part of factor 3: pressure to acculturate, and factor 4: pressure against acculturation. Response options begin with a stem: Has this occurred in the last 3 months? Yes or no. If yes, how worrying/stressful has this been? Follow-up response options range from 1-Not at all worrying/stressful to 5-Extremely worrying/stressful. Final scores reflect incidence of stress exposure (sum of "yes" stem responses) and stress responsiveness (average of follow-up stressfulness scores).

    Time frame: 3-4 months

  2. Parent acculturative stress

    Items from the Multidimensional Acculturative Stress Inventory for Adults of Mexican Origin (MASI) were used (Rodriguez et al. \[2002\]. Development of the Multidimensional Acculturative Stress Inventory for Adults of Mexican Origin. Psychological Assessment, 14\[4\], 451-461.) The MASI is a 36-item stress measure that assesses acculturative stress among persons of Mexican origin living in the United States;10 items were selected that are part of factor 3: pressure to acculturate, and factor 4: pressure against acculturation. Response options begin with a stem: Has this occurred in the last 3 months? Yes or no. If yes, how worrying/stressful has this been? Follow-up response options range from 1-Not at all worrying/stressful to 5-Extremely worrying/stressful. Final scores reflect incidence of stress exposure (sum of "yes" stem responses) and stress responsiveness (average of follow-up stressfulness scores).

    Time frame: 3-4 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Yes — A de-identified data set is available to other researchers and can be accessed through contacting either study PI.

Supporting information: Study protocol, Informed consent form

Time frame: Data will be available by January 2022 and available indefinitely.

Access criteria: Researchers interested in accessing the data must share their contact information with PIs.

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2016 to primary completion in Mar 2021, 55 months.

Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's 55 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 30, 2021
First posted
Jun 29, 2022
StartActual
Aug 2016
Primary completionActual
Mar 31, 2021
CompletionActual
Mar 31, 2021
Last update
Jun 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05437081
Lead sponsor
University of Oregon
Responsible party
Sponsor
First posted
Jun 29, 2022
Start date
Aug 2016
Primary completion
Mar 31, 2021
Completion
Mar 31, 2021
Last update
Jun 29, 2022

Study contacts

Heather H McClure, PhD
principal investigator · University of Oregon
Seth J Schwartz, PhD
principal investigator · University of Texas at Austin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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