Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05863182 |
| Other study ID # |
STUDY00000702-MOD03 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2024 |
| Est. completion date |
July 31, 2025 |
Study information
| Verified date |
August 2023 |
| Source |
University of Texas at Austin |
| Contact |
Elma Lorenzo-Blanco, PhD |
| Phone |
5124713141 |
| Email |
elma[@]utexas.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The primary objective of this study is to develop and pilot-test a family-based Latino youth
alcohol use preventive intervention for Latino youth (ages 14-16) and one of their parents.
The preventive intervention will equip youth, parents, and families with skills to manage
stress related to prejudice, discrimination, and racism as a means to reduce Latino youth
alcohol use risk. Informed by ecodevelopmental, social norms, family stress, stress and
coping theories, and racial socialization theories, the central hypothesis is that active
coping skills can buffer against the negative effect of social stressors (i.e., experiences
related to prejudice, discrimination, and racism) on youth alcohol outcomes/related
risks/cognitions; and active coping skills can offset the negative effect of social stress on
parental adjustment, family functioning and parenting behaviors, thereby reducing youth
alcohol use risk. Using an iterative approach to intervention development, within a
mixed-method research design, the purpose of this study is to construct intervention sessions
that impart active coping skills to better manage social stress related to prejudice,
discrimination, and racism. In Aim 1, we will use qualitative methods to inform the
development of intervention sessions that target coping with prejudice, discrimination, and
racism. I will conduct focus groups with youth (5 groups, n=6-8) and parents (5 groups,
n=6-8) to identify how youth and parents experience and cope with perceived ethnic
discrimination; the skills and resources they would like to further develop; and to seek
input regarding the structure and logistics of the intervention. In Aim 2, we will create a
family-based youth alcohol use preventive intervention curriculum that targets coping with
prejudice, discrimination, and racism. I will identify strategies used in existing preventive
interventions and draw from Aim 1 qualitative findings to develop tentative intervention
sessions. We will then conduct focus groups with youth (5 groups, n=6-8) and parents (5
groups, n=6-8) to seek feedback on tentative intervention sessions. We will then integrate
focus group data into the intervention curriculum and modify it accordingly and develop
manuals in English and Spanish. In Aim 3, we will pilot test the intervention among Latino
families (i.e., one youth and one parent) in Texas. We will pilot test the intervention with
60 families (i.e., youth-parent dyads; N=30 intervention group; N = 30 comparison group) from
high schools in the Austin Independent School District to a) assess intervention feasibility
and acceptability, and b) determine preliminary effect size estimates for the intervention's
promise to improve youth and parent coping skills, family functioning, parenting behaviors,
and youth alcohol outcomes.
Description:
SCHOOL SELECTION FOR QUASI-EXPERIMENTAL GROUP DESIGN. For aim 4, we have selected two out of
five high schools that are closely are closely matched on the following criteria: 1) % Latino
student enrollment (85.6 and 84.7), 2) % of students classified as economically disadvantaged
(83 and 87), 3) Student achievement scores (66 and 69), 4) Student attendance scores (92 and
93), and 5) Student mobility rate (25.8 and 25.1). The matching of the two pilot study
schools on these criteria, will allow us to eliminate any potential confounds that might
preclude us from teasing apart the effects of the intervention from potential confounding
school level effects. If the proposed intervention shows promise, we will be able to
systematically test for school level effects in a larger, future study. We then propose to
randomly assign one of the two schools to serve as intervention school and one of the two
schools to serve as comparison school. The random assignment of one school to serve as
intervention and one school to serve as comparison school will demonstrate the feasibility of
randomization for a future larger study and will eliminate concerns about crossover and
contamination.
Families from the intervention school (N = 30) will then be assigned to one of three
intervention groups, each consisting of about 10 families (i.e., one youth and one parent),
based on their language preference (English vs. Spanish). These families will then
participate in the 9 week pilot intervention and fill-out a pre- and post-assessment battery.
Families from the comparison school (N = 30) will receive weekly information packages and
fill out the pre- and post-assessment battery in the same week as the intervention school
families.
For both groups, we will aim towards equal representation of boys and girls as well as U.S.
and foreign-born youth. In line with the academic calendar of all the schools, we will aim to
deliver the intervention from January to May to avoid delays due to school holidays and
vacation.
Intervention Families will receive intervention sessions designed in PHASES 1-3. Sessions
will be delivered in English or Spanish, based on participants' language preferences. We will
conduct three groups (10 families and 2 facilitators/group). Although the time and location
will be determined after study PHASE 3, based on my discussions with AISD, intervention
sessions may be offered after school in a safe room. Incentives will include weekly
non-monetary incentives, starting with small incentives (e.g., pens) and increasing the
incentive value in later weeks (e.g., t-shirts). Each session will include a meal. Also, the
time and location of the intervention will be determined based on the qualitative interview
feedback. Participants will receive $30 for each completed assessment. Intervention session
content will be delivered through short presentations, small/large group discussions,
role-plays, exercises and practice of new skills. Each session will include home practice of
new skills. Sessions will be digitally recorded. Recording will be used for future
intervention refinement. Participants will be asked to respect the privacy of other group
members. Facilitators: The PI will lead intervention sessions with a bilingual facilitator.
The PI will, in consultation with co-primary mentors, Martinez and Marsiglia, train the
facilitator by reviewing the intervention manual, emphasizing the purpose of each
intervention component session and the need to not modify the manual. We will conduct mock
intervention sessions and provide in-person feedback.
Comparison Families will receive 8 to 10 weekly information packages about the college
application process. An information package may provide information about the application
timeline and planning process. Participants will receive the information packages the same
week the intervention families meet and sign a receipt for each package. Incentives:
Comparison families will receive the same incentives as intervention families: weekly
non-monetary incentives for picking up information packages and $30 for each completed
assessment.
.2.
STATISTICAL DESIGN & POWER CONSIDERATIONS.
We will evaluate the feasibility and acceptability of the intervention with the following
measures: number of families screened and enrolled per week, retention rates of intervention
and comparison families, duration of assessment surveys and missing data, proportion of
families who complete protocols for intervention and comparison intervention families,
attendance at intervention sessions, preferred language for the intervention and comparison
families, intervention engagement and interest, and reports of perceived barriers and
facilitators for intervention participation.
We will also estimate whether the intervention shows promise on improving youth and parent
coping skills, family functioning, and parenting behaviors and whether it shows promise in
preventing youth alcohol outcomes and cognitions. The primary outcome of interest is coping
skills. We will estimate the effect of the intervention on coping skills separately for youth
and parents. Secondary outcomes include family functioning, parenting behaviors, alcohol
use/related risks and alcohol related cognitions. We will estimate the effect of the
intervention on family functioning, parenting behaviors, alcohol use/related risk and alcohol
related cognitions separately for youth and parents.
In all intervention impact analyses, student and family outcomes will be compared for the
intervention and comparison groups using an intention to treat (ITT) approach. We will use a
generalized linear modeling framework, where post-intervention outcome measures will be
regressed on an indicator variable for intervention versus comparison group status, while
statistically controlling for baseline levels of coping skills, ethnic discrimination, and
demographic variables.
Intervention impact estimates will be translated into standardized effect size indices (e.g.,
standardized mean differences, risk ratios) to facilitate interpretation of the magnitude and
direction of potential intervention effects. Multiplicative interaction terms will be added
to the generalized linear models to explore possible differential effects of the intervention
on coping skills, family functioning, parenting behaviors, and alcohol outcomes and
cognitions based on dosage and demographic variables.
Missing data will be handled with multiple imputation or full-information maximum
likelihood-based approaches, presuming the data can be reasonably assumed to be missing at
random. Should missing data or attrition be associated with covariates, appropriate
covariates will be included in all impact analyses.
Given the exploratory nature of the proposed study, the moderate sample size, and a desire to
detect early signs of promise of the intervention, we will focus on effect size estimates
(e.g., 95% confidence intervals, standardized mean differences, Cohen's f), rather than on
statistical significance. Co-primary mentor Martinez was able to identify beneficial effects
of Nuestras Familias on parenting and youth outcomes with a sample of 73 families and such we
believe that our sample size of 60 families will allow us to detect signs of promise of the
intervention. Focusing on effect size estimates in this pilot feasibility study will allow me
to plan a formal test of the intervention in a randomized trial (R01) to assess the efficacy
of the intervention, isolate school level effects on intervention outcomes, and examine
mediating and moderating mechanisms.
