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Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents

Primary Purpose

Underage Alcohol Use, Smoking, Non-Tobacco Products

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GMIT
GMIT+
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Underage Alcohol Use

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

GMIT

Modified GMIT + Parenting support groups

Outcomes

Primary Outcome Measures

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
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
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
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.
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
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
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
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
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
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.
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.
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.
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.

Secondary Outcome Measures

Program feasibility
Change in number of dyads enrolled in the study and number who completed the intervention

Full Information

First Posted
May 9, 2019
Last Updated
June 28, 2022
Sponsor
Virginia Commonwealth University
Collaborators
Virginia Foundation of Healthy Youth, Sacred Heart Center, Virginia Polytechnic Institute and State University, The College of William and Mary
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1. Study Identification

Unique Protocol Identification Number
NCT03947177
Brief Title
Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents
Official Title
Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2019 (Actual)
Primary Completion Date
September 21, 2021 (Actual)
Study Completion Date
September 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Virginia Foundation of Healthy Youth, Sacred Heart Center, Virginia Polytechnic Institute and State University, The College of William and Mary

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Underage Alcohol Use, Smoking, Non-Tobacco Products

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
GMIT
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Modified GMIT + Parenting support groups
Intervention Type
Behavioral
Intervention Name(s)
GMIT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GMIT+
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in tobacco use intentions
Description
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
Time Frame
Baseline to 3 months
Title
Change in tobacco use attitudes
Description
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
Time Frame
Baseline to 3 months
Title
Change in smoking refusal intentions
Description
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
Time Frame
Baseline to 3 months
Title
Change in marijuana or other drug refusal intentions
Description
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.
Time Frame
Baseline to 3 months
Title
Change in parent-child communication about tobacco
Description
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
Time Frame
Baseline to 3 months
Title
Change in parental monitoring - adolescent
Description
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
Time Frame
Baseline to 3 months
Title
Change in parental monitoring - parent
Description
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
Time Frame
Baseline to 3 months
Title
Change in parent-child conflict - adolescent
Description
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
Time Frame
Baseline to 3 months
Title
Change in parent-child conflict - parent
Description
20-item conflict scale completed by parents. Each item is scored 0 (False) or 1 (True) yielding scores ranging from 0 to 20
Time Frame
Baseline to 3 months
Title
Change in family cohesiveness - adolescent
Description
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.
Time Frame
Baseline to 3 months
Title
Change in family cohesiveness - parent
Description
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.
Time Frame
Baseline to 3 months
Title
Change in parent-child communication - adolescent
Description
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.
Time Frame
Baseline to 3 months
Title
Change in parent-child communication - parent
Description
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.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Program feasibility
Description
Change in number of dyads enrolled in the study and number who completed the intervention
Time Frame
Baseline to 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosalie Corona, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents

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