An interventional study of GMIT and GMIT+ in Underage Alcohol Use and Smoking, Non-Tobacco Products, sponsored by Virginia Commonwealth University. Completed at 1 site in United States. Open to participants aged 10 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Basic science
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.
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.
44 studies on the registry are indexed under Underage Drinking; 13 are open to participants now.
This study's enrollment of 59 is below the median of 360 across 43 interventional studies indexed under Underage Drinking.
Browse Underage Drinking studies →Virginia Commonwealth University is the lead sponsor of 648 studies on the registry; 80 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 64 (71%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
GMIT
Behavioral: GMIT
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.
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.
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months
Program feasibility
Change in number of dyads enrolled in the study and number who completed the intervention
Time frame: Baseline to 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Sep 2021, 24 months.
Of 34 non-industry interventional studies with no phase under Underage Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 24 months is close to that.
Counting every sponsor, half of 36 studies reached it within 24 months; a quarter within 12 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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