Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents

The purpose of this study is to compare two versions of an intervention focused on teaching 10-14-year-old Latina/o adolescent's skills that will decrease the likelihood that they will use tobacco, alcohol, and other drugs. We are also interested in determining how cultural context is related to substance use and whether additional information about other tobacco products should be added to the GMIT intervention.

Study Overview

• Status: Completed
• Conditions: Underage Alcohol Use; Smoking, Non-Tobacco Products
• Intervention / Treatment: Behavioral: GMIT; Behavioral: GMIT+

Detailed Description

All adolescents will receive the Group Motivational Interviewing for Teens (GMIT) intervention. GMIT is an evidence-based group intervention that has been shown to prevent substance use among adolescents. In this project, GMIT will be delivered virtually in a group setting to multiple Latina/o adolescents. In addition, some parents will virtually participate in a parent-only support group; the other parents will not participate in any group.

In this study, participants will be randomly assigned (like flipping a coin) to receive one of two versions of an alcohol, drug, and tobacco program. As part of the program teen participants will virtually attend six 30-min intervention sessions with other teens. Parents may also participate in virtual group sessions. Participants will be asked on three separate occasions (before, immediately after, and 3 months after the sessions) to complete forms (phone/online) that ask questions about teens behavior at home, school, and in the community.

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adolescents must be between 10 and 16 years of age - parents can be any age
• Parent and adolescent must consent/assent to participate as dyad
• Self-identify as Latina/o or Hispanic

Exclusion Criteria:

• Under the age of 10 or over the age of 16
• Parent or adolescent refuses
• Identify as non-Latina/o or non-Hispanic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Control; GMIT	Behavioral: GMIT; Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices.
Experimental: Intervention; Modified GMIT + Parenting support groups	Behavioral: GMIT+; Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices. Parents and/or guardians will virtually participate in parent-only support group sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in tobacco use intentions	4-item self-reported tobacco use scale. Each item is scored from 1 (definitely yes) to 4 (definitely no) yielding a range between 4 and 16	Baseline to 3 months
Change in tobacco use attitudes	7-item self-reported attitudes about tobacco scale. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 7 and 28	Baseline to 3 months
Change in smoking refusal intentions	7 item self-reported smoking refusal intentions scale. Each item is scored from 1 (Definitely would say "No") to 5 (Definitely would not say "No") yielding a range from 7 to 35	Baseline to 3 months
Change in marijuana or other drug refusal intentions	5-item self-reported marijuana or other drug refusal intentions scale. Each item is scored from 1 (Definitely would) to 5 (Definitely would not) yielding a range from 5 to 25.	Baseline to 3 months
Change in parent-child communication about tobacco	6-item self-reported antismoking socialization scale. Item scores vary depending on response type (Yes/no or Likert scale). Total scores range from 0 to 9	Baseline to 3 months
Change in parental monitoring - adolescent	24-item self-reported parenting practices scale completed by adolescents. Each item is scored from 1 (high monitoring) to 5 (low monitoring) yielding a range from 24 to 120	Baseline to 3 months
Change in parental monitoring - parent	24-item self-reported parenting practices scale completed by parents. Each item is scored from 1 (high monitoring) to 5 (low monitoring) yielding a range from 24 to 120	Baseline to 3 months
Change in parent-child conflict - adolescent	3-item conflict scale completed by adolescents. Each item is scored 1 (Never or Hardly at all) to 5 (Always or Extremely much) yielding scores ranging from 3 to 15	Baseline to 3 months
Change in parent-child conflict - parent	20-item conflict scale completed by parents. Each item is scored 0 (False) or 1 (True) yielding scores ranging from 0 to 20	Baseline to 3 months
Change in family cohesiveness - adolescent	10-item Family Adaptability and Cohesion Evaluation Scale completed by adolescents. Each item is scored from 1 (almost never) to 5 (almost always) yielding a range from 10 to 50.	Baseline to 3 months
Change in family cohesiveness - parent	10-item Family Adaptability and Cohesion Evaluation Scale completed by parents. Each item is scored from 1 (almost never) to 5 (almost always) yielding a range from 10 to 50.	Baseline to 3 months
Change in parent-child communication - adolescent	20-item Parent-Adolescent Communication Scale completed by adolescents. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 20 and 100.	Baseline to 3 months
Change in parent-child communication - parent	20-item Parent-Adolescent Communication Scale completed by parents. Each item is scored from 1 (strongly disagree) to 4 (strongly agree) yielding a range between 20 and 100.	Baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program feasibility	Change in number of dyads enrolled in the study and number who completed the intervention	Baseline to 6 weeks

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Virginia Polytechnic Institute and State University; Virginia Foundation of Healthy Youth; Sacred Heart Center; The College of William and Mary
• Investigators: Principal Investigator: Rosalie Corona, PhD, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2019
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 28, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking; Underage Drinking
• Other Study ID Numbers: HM20014435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No