Recruiting

Intervention Trial

Sponsor:

Oklahoma State University

Code:

NCT03642106

Conditions

Substance Use

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

Interventions

Unidos Se Puede

Study Details

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

Study ID

NCT03642106

Start date

Jan 1, 2020

Status verified date

Jul, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Aug 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: Attention placebo control

Placebo consists of after school club for youth.

Interventions

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.

Primary outcome measure

  • Change in past 30-day ATOD use (alcohol, tobacco, marijuana) [ Time Frame: Baseline and 12 months post-baseline ]

Central Contacts and Locations

Central contacts

Ronald B Cox, PhD

4057449938r.cox@okstate.edu

Isaac Washburn, PhD

4057443683Isaac.washburn@okstate.edu

Locations

Oklahoma State University-Tulsa

Recruiting

Tulsa, Oklahoma, United States, 74106

Contacts

Ronald B Cox, PhD

405-744-9938r.cox@okstate.edu

Isaac Washburn, PhD

4057443683isaac.washburn@okstate.edu

More Information

Sponsor

Oklahoma State University

Last update posted

Jul 27, 2022

Last verified

Jul, 2022

Keywords

  • Adolescent
  • Latino
  • Immigrant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oklahoma State University on 2022-07-27.