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Binge Alcohol ConsumptionLEANCT05437081

A Family-Based Alcohol Preventive Intervention for Latino Emerging Adults

A study testing Latino Emerging Adults (LEA) in people with Binge Alcohol Consumption and Risk Behavior, Health, run by University of Oregon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Latino Emerging Adults (LEA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
No sites listed yet
Study dates
Aug 2016to 31 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Emerging adult criteria:
  • EAs are not themselves a parent or stepparent

About this study

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.

Being tested
Latino Emerging Adults (LEA)
Medical subject headings
Binge Drinking, Health Risk Behaviors, Driving Under the Influence, Unsafe Sex, Social Identification

What participants receive

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

  • Latino Emerging Adults (LEA)Behavioural

    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.

Study groups in NCT05437081
Study groupRoleWhat they receive
EMERGE programExperimentalParticipants 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.
Receives: Behavioral: Latino Emerging Adults (LEA)
Referral services as neededNo interventionParticipants were randomly assigned to one of two conditions: intervention or control. Control participants received services as usual.

What is being measured

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

  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.)

    Measured: 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.)

    Measured: 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.)

    Measured: 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.)

    Measured: 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?

    Measured: 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?

    Measured: 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.)

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.)

    Measured: 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.

    Measured: 3-4 months

Secondary outcomes (2)
  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).

    Measured: 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).

    Measured: 3-4 months

Timeline

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

  1. First posted29 Jun 2022
  2. Study startAug 2016
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

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
Model description
Latino emerging adults (EAs)and Latino parents of EAs were recruited in Oregon and Florida. Participants were then randomly selected into either the intervention or the control condition. Participants randomized to the control condition received referrals to community agencies for mental health, substance abuse, and health issues commonly experienced by EAs. Participants randomized to the intervention condition were invited to attend four family-focused sessions (for parents) or four identity development-focused sessions (for EAs).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05437081
Sponsor's protocol ID
06162016.026
Acronym
LEA
Status last verified
Jun 2022
First submitted
30 Nov 2021
Last updated
29 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: A de-identified data set is available to other researchers and can be accessed through contacting either study PI.

Questions about this trial

What is this clinical trial studying?

A study testing Latino Emerging Adults (LEA) in people with Binge Alcohol Consumption and Risk Behavior, Health, run by University of Oregon.

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 2 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: finished, as of the sponsor's last update on 29 Jun 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emerging Adult Self-Efficacy (time frame: 3-4 months). The study lists 13 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 29 Jun 2022.

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