Unidos Against ATOD Use Intervention Trial

NCT03642106 | Unknown

• 3 other identifiers: IRB-21-2905P20GM109097-021R15DA049232-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Keywords

Adolescent; Latino; Immigrant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Unidos Se Puede

ACTIVE COMPARATOR

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.

Behavioral: Unidos Se Puede

Attention placebo control

PLACEBO COMPARATOR

Placebo consists of after school club for youth.

Behavioral: Unidos Se Puede

Interventions

Unidos Se Puede BEHAVIORAL

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.

Also known as: UWC

Attention placebo control; Unidos Se Puede

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oklahoma State University: lead
• National Institute of General Medical Sciences (NIGMS): collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Oklahoma State University-Tulsa

Tulsa, Oklahoma, 74106, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 34710334 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ronald B Cox, PhD

  Oklahoma State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ronald B Cox, PhD

CONTACT

4057449938; r.cox@okstate.edu

Isaac Washburn, PhD

CONTACT

4057443683; Isaac.washburn@okstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: August 22, 2018
• Study Start: January 1, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

US (1)