Clinical trial NCT03642106: Unidos Against ATOD Use Intervention Trial
Official title: Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use
Keywords: Adolescent
Latino
Immigrant
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
name: National Institute on Drug Abuse (NIDA)
First posted: 2018-08-22
Enrollment: 240
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To accomplish the mentioned aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each).

Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
Primary purpose: PREVENTION

Brief summary: Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The proposed project examines the preliminary efficacy of Unidos to decrease ATOD use among Latino youth in new settlement areas. The goals of this efficacy trial will be achieved by accomplishing two specific aims: (1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.

The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.

Detailed description: Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The overall aim of this project is to test the efficacy of a culturally appropriate psychosocial program to prevent or reduce ATOD use among Latino immigrant youth. The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.

The specific aims are:

(1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.

The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.

To accomplish these aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.

Eligibility criteria: Inclusion Criteria:

* Self-identified as Latino (Hispanic),
* Spanish as the primary language spoken in home,
* Enrolled in 6th or 7th grade in public school at one of the target sites.

Exclusion Criteria:

* Currently undergoing mental health treatment,
* Not eligible to take end of year examinations due to cognitive limitations.

Primary outcomes:
measure: Change in past 30-day ATOD use (alcohol, tobacco, marijuana)
timeFrame: Baseline and 12 months post-baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Oklahoma State University-Tulsa
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: Ronald B Cox, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox RB, Washburn I, Greder K, Sahbaz S, Lin H. Preventing substance use among Latino youth: Initial results from a multistate family-based program focused on youth academic success. Am J Drug Alcohol Abuse. 2022 Jan 2;48(1):69-77. doi: 10.1080/00952990.2021.1981357. Epub 2021 Oct 28.