Underage Alcohol UseNCT03947177
Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents
A study testing GMIT and GMIT+ in people with Underage Alcohol Use and Smoking, Non-Tobacco Products, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Underage Alcohol Use, Smoking, Non-Tobacco Products
- What is being tested?
- GMIT and GMIT+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 21 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Under the age of 10 or over the age of 16
- Parent or adolescent refuses
- Identify as non-Latina/o or non-Hispanic
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Being tested
- GMIT, GMIT+
- Medical subject headings
- Underage Drinking, Smoking, Non-Tobacco Products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMITBehavioural
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+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | GMIT Receives: Behavioral: GMIT |
| Intervention | Experimental | Modified GMIT + Parenting support groups Receives: Behavioral: GMIT+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 months
Secondary outcomes (1)
Program feasibility
Change in number of dyads enrolled in the study and number who completed the intervention
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start9 Sep 2019
- Primary completion21 Sep 2021
- Study completion21 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Underage Alcohol UseStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Foundation of Healthy Youth, Sacred Heart Center, Virginia Polytechnic Institute and State University, William & Mary
- Responsible party
- Sponsor
- Investigators
- Rosalie Corona, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947177
- Sponsor's protocol ID
- HM20014435
- Status last verified
- Jun 2022
- First submitted
- 9 May 2019
- Last updated
- 30 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Enhancing a Motivational Interviewing Intervention For Latinx Adolescents
- ClinicalTrials.gov ID
- NCT03947177
- Acronym / sponsor ID
- HM20014435
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Virginia Foundation of Healthy Youth, Sacred Heart Center, Virginia Polytechnic Institute and State University, William & Mary
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 21 Sep 2021 (actual)
- Study completion
- 21 Sep 2021 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Behavioral: GMITGMIT |
| Intervention | Experimental | Behavioral: GMIT+Modified GMIT + Parenting support groups |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Under the age of 10 or over the age of 16
- Parent or adolescent refuses
- Identify as non-Latina/o or non-Hispanic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMITSix 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. | Behavioural | Control |
| 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. | Behavioural | Intervention |
Primary outcome
Change in tobacco use intentions
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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
Time frame: Baseline to 3 months
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.
1 secondary outcome
Program feasibility
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosalie Corona, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GMIT and GMIT+ in people with Underage Alcohol Use and Smoking, Non-Tobacco Products, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tobacco use intentions (time frame: Baseline to 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.