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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03947177
Other study ID # HM20014435
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 9, 2019
Est. completion date September 21, 2021

Study information

Verified date June 2022
Source Virginia Commonwealth University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 10 Years to 16 Years
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
United States Virginia Commonwealth University Richmond Virginia

Sponsors (5)

Lead Sponsor Collaborator
Virginia Commonwealth University Sacred Heart Center, The College of William and Mary, Virginia Foundation of Healthy Youth, Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 Program feasibility Change in number of dyads enrolled in the study and number who completed the intervention Baseline to 6 weeks
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