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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05437081
Other study ID # 06162016.026
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2016
Est. completion date March 31, 2021

Study information

Verified date June 2022
Source University of Oregon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date March 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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: Emerging adult criteria: • EAs are not themselves a parent or stepparent

Study Design


Intervention

Behavioral:
Latino 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Oregon

Outcome

Type Measure Description Time frame Safety issue
Primary 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.) 3-4 months
Primary 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.) 3-4 months
Primary 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.) 3-4 months
Primary 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.) 3-4 months
Primary 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:
Have ever tried even a few sips of alcohol? Yes No (if no, skip to #3)
If YES: How old were you when you first tried at least a few sips of alcohol? _____ years old
During the last 3 months, what was the HIGHEST number of drinks that you drank in a single day?
3-4 months
Primary 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? 3-4 months
Primary 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.) 3-4 months
Primary 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. 3-4 months
Primary 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. 3-4 months
Primary 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. 3-4 months
Primary 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. 3-4 months
Primary 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.) 3-4 months
Primary 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. 3-4 months
Secondary 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). 3-4 months
Secondary 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). 3-4 months
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