Unidos Against ATOD Use Intervention Trial

Substance Use Clinical Trial

— TWC  

Official title:

Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03642106
• Other study ID #: IRB-21-290
• Secondary ID: 5P20GM109097-021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: August 31, 2023

Study information

• Verified date: July 2022
• Source: Oklahoma State University
• Contact: Ronald B Cox, PhD
• Phone: 4057449938
• Email: r.cox[@]okstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

Intervention

Behavioral:
• Unidos Se Puede
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.

Locations

Country	Name	City	State
United States	Oklahoma State University-Tulsa	Tulsa	Oklahoma

Sponsors (3)

Lead Sponsor	Collaborator
Oklahoma State University	National Institute of General Medical Sciences (NIGMS), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in past 30-day ATOD use (alcohol, tobacco, marijuana)	The ATOD outcome measure creates a single index of use by summing youth report of the frequency of their use during the past 30 days for each of the following substance: alcohol, tobacco and marijuana.	Baseline and 12 months post-baseline