Unidos Against ATOD Use Intervention Trial

NCT ID: NCT03642106

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-08-31

Brief Summary

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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

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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.

Conditions

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Substance Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Unidos Se Puede

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.

Group Type ACTIVE_COMPARATOR

Unidos Se Puede

Intervention Type 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.

Attention placebo control

Placebo consists of after school club for youth.

Group Type PLACEBO_COMPARATOR

Unidos Se Puede

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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UWC

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of General Medical Sciences (NIGMS)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Oklahoma State University

OTHER

Sponsor Role lead

Responsible Party

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Ronald Cox

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ronald B Cox, PhD

Role: PRINCIPAL_INVESTIGATOR

Oklahoma State University

Locations

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Oklahoma State University-Tulsa

Tulsa, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ronald B Cox, PhD

Role: CONTACT

4057449938

Isaac Washburn, PhD

Role: CONTACT

4057443683

Facility Contacts

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Ronald B Cox, PhD

Role: primary

405-744-9938

Isaac Washburn, PhD

Role: backup

4057443683

References

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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.

Reference Type DERIVED
PMID: 34710334 (View on PubMed)

Other Identifiers

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5P20GM109097-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1R15DA049232-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-21-290

Identifier Type: -

Identifier Source: org_study_id

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