Unidos Against ATOD Use Intervention Trial (TWC)
Primary Purpose
Substance Use
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unidos Se Puede
Sponsored by
About this trial
This is an interventional prevention trial for Substance Use focused on measuring Adolescent, Latino, Immigrant
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.
Sites / Locations
- Oklahoma State University-TulsaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Unidos Se Puede
Attention placebo control
Arm Description
Unidos Se Puede: consists of 5-weekly Family Workshops, 6 monthly booster sessions, 10-months success coaching, adolescent group activities and will be compared to an attention placebo control.
Placebo consists of after school club for youth.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03642106
First Posted
April 13, 2018
Last Updated
July 26, 2022
Sponsor
Oklahoma State University
Collaborators
National Institute of General Medical Sciences (NIGMS), National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03642106
Brief Title
Unidos Against ATOD Use Intervention Trial
Acronym
TWC
Official Title
Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
August 31, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oklahoma State University
Collaborators
National Institute of General Medical Sciences (NIGMS), National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use
Keywords
Adolescent, Latino, Immigrant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Unidos Se Puede
Arm Type
Active Comparator
Arm Description
Unidos Se Puede: consists of 5-weekly Family Workshops, 6 monthly booster sessions, 10-months success coaching, adolescent group activities and will be compared to an attention placebo control.
Arm Title
Attention placebo control
Arm Type
Placebo Comparator
Arm Description
Placebo consists of after school club for youth.
Intervention Type
Behavioral
Intervention Name(s)
Unidos Se Puede
Other Intervention Name(s)
UWC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in past 30-day ATOD use (alcohol, tobacco, marijuana)
Description
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.
Time Frame
Baseline and 12 months post-baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronald B Cox, PhD
Phone
4057449938
Email
r.cox@okstate.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Isaac Washburn, PhD
Phone
4057443683
Email
Isaac.washburn@okstate.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald B Cox, PhD
Organizational Affiliation
Oklahoma State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oklahoma State University-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74106
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald B Cox, PhD
Phone
405-744-9938
Email
r.cox@okstate.edu
First Name & Middle Initial & Last Name & Degree
Isaac Washburn, PhD
Phone
4057443683
Email
isaac.washburn@okstate.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
The intent to share data with other researchers exists, however, a plan to do so has not yet been developed.
Citations:
PubMed Identifier
34710334
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.
Results Reference
derived
Learn more about this trial
Unidos Against ATOD Use Intervention Trial
We'll reach out to this number within 24 hrs