AlcoholismAMICANCT01948700
Assessing the Fit of Motivational Interviewing by Cultures With Adolescents
A study testing Motivational Interviewing and Education in people with Alcoholism, run by University of New Mexico at 1 site in United States.
Trial summary
Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment, particularly among justice-involved youth. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Alcoholism
- What is being tested?
- Motivational Interviewing and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jul 2015
- 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 13 - 18
- Provision of informed assent (or self-consent if age 18)
- Parent/ guardian consent if under age 18
- Regular substance use (use at least 1 per month for past 6 months)
Who cannot join
- active psychosis
- mental retardation
- neurodevelopmental disorder
- severe medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Center on Alcoholism, Substance Abuse, and Addictions
Albuquerque, New Mexico, 87106
About this study
Official title: AMICA: Assessing the Fit of Motivational Interviewing by Cultures With Adolescents
Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment, particularly among justice-involved youth. Despite the level of research that has been conducted on motivational interviewing (MI) with mainstream samples, no published studies have investigated the efficacy of this brief, individual intervention with Hispanic adolescents. The overarching objective of this application is to evaluate the efficacy of a brief individual intervention (MI) for problem drinking behaviors with a sample of justice-involved Hispanic and Caucasian adolescents to determine if this intervention is differentially effective between Hispanic and Caucasian adolescents. Specifically, the first aim is to determine whether an MI intervention targeting alcohol abuse is effective at reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The second aim is to examine whether the effects of MI on problem drinking outcomes (e.g., alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic versus Caucasian adolescents. Because it is important to determine the mechanisms that mediate the effects of MI and determine whether these mechanisms differ between Caucasian and Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian) moderates the mediational linkages in the overall model using a cross-groups approach to moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI interventions (one at baseline and a second, one week later) or an education condition. All adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed research is expected to take a significant step towards reducing current racial/ethnic health disparities in alcohol treatment for Hispanic adolescents.
- Conditions
- Alcoholism
- Being tested
- Motivational Interviewing, Education
- Keywords
- Motivational Interviewing, Problem Drinking, Adolescents, Minority Health
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Brief Intervention | Other | Motivational Interviewing (MI) Receives: Behavioral: Motivational Interviewing |
| Standard Intervention | Other | Education Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of alcohol use
Measured: Change from baseline in frequency of alcohol use at 3 , 6 , & 12 month follow-up
Secondary outcomes (1)
Quantity of alcohol use
Measured: Change from baseline in quantity of alcohol use at 3 , 6 , & 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startOct 2009
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Not an Applicable Clinical Trial (ACT).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 506 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Sarah W. Feldstein Ewing, Ph. D., Principal investigator, Assistant Professor UNM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948700
- Sponsor's protocol ID
- 5R01AA017878-05
- Other IDs
- 5R01AA017878-05
- Acronym
- AMICA
- Status last verified
- Mar 2024
- First submitted
- 16 Sep 2013
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Feldstein Ewing S, Bryan AD, Dash GF, Lovejoy TI, Borsari B, Schmiege SJ. Randomized controlled trial of motivational interviewing for alcohol and cannabis use within a predominantly Hispanic adolescent sample. Exp Clin Psychopharmacol. 2022 Jun;30(3):287-299. doi: 10.1037/pha0000445. Epub 2021 Mar 22.
PubMed 33749294
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMICA: Assessing the Fit of Motivational Interviewing by Cultures With Adolescents
- ClinicalTrials.gov ID
- NCT01948700
- Acronym / sponsor ID
- AMICA / 5R01AA017878-05
- Conditions
- Alcoholism
- Keywords
- Motivational Interviewing, Problem Drinking, Adolescents, Minority Health
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not an Applicable Clinical Trial (ACT).
- Enrolment
- 506 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Oct 2009 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Sep 2013 (estimated)
- 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.
Hispanic adolescents experience more severe alcohol-related consequences due to their alcohol abuse and yet significantly fewer Hispanic adolescents receive alcohol treatment, particularly among justice-involved youth. Despite the level of research that has been conducted on motivational interviewing (MI) with mainstream samples, no published studies have investigated the efficacy of this brief, individual intervention with Hispanic adolescents. The overarching objective of this application is to evaluate the efficacy of a brief individual intervention (MI) for problem drinking behaviors with a sample of justice-involved Hispanic and Caucasian adolescents to determine if this intervention is differentially effective between Hispanic and Caucasian adolescents. Specifically, the first aim is to determine whether an MI intervention targeting alcohol abuse is effective at reducing alcohol use and related risk behavior in a sample of adolescent alcohol abusers. The second aim is to examine whether the effects of MI on problem drinking outcomes (e.g., alcohol problems, quantity of drinking, frequency of binging) are different between Hispanic versus Caucasian adolescents. Because it is important to determine the mechanisms that mediate the effects of MI and determine whether these mechanisms differ between Caucasian and Hispanic adolescents, the third aim is to examine whether group (Hispanic vs. Caucasian) moderates the mediational linkages in the overall model using a cross-groups approach to moderated mediation. To accomplish these aims, 453 Caucasian and Hispanic justice-involved alcohol abusing adolescents (ages 14-17) will be randomized to either two 60 minute MI interventions (one at baseline and a second, one week later) or an education condition. All adolescents will receive behavioral assessments at baseline, 3, 6 and 12 months. The proposed research is expected to take a significant step towards reducing current racial/ethnic health disparities in alcohol treatment for Hispanic adolescents.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Intervention | Other | Behavioral: Motivational InterviewingMotivational Interviewing (MI) |
| Standard Intervention | Other | Other: EducationEducation |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 13 - 18
- Provision of informed assent (or self-consent if age 18)
- Parent/ guardian consent if under age 18
- Regular substance use (use at least 1 per month for past 6 months)
Key exclusion criteria (4 listed)
- active psychosis
- mental retardation
- neurodevelopmental disorder
- severe medical illness
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 |
|---|---|---|
| Motivational Interviewing | Behavioural | Brief Intervention |
| Education | Other | Standard Intervention |
Primary outcome
Frequency of alcohol use
Time frame: Change from baseline in frequency of alcohol use at 3 , 6 , & 12 month follow-up
1 secondary outcome
Quantity of alcohol use
Time frame: Change from baseline in quantity of alcohol use at 3 , 6 , & 12 month follow-up
Results and safety
The study was stopped early (reason given: Not an Applicable Clinical Trial (ACT).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Derived from this study: PubMed 33749294Feldstein Ewing S, Bryan AD, Dash GF, Lovejoy TI, Borsari B, Schmiege SJ. Randomized controlled trial of motivational interviewing for alcohol and cannabis use within a predominantly Hispanic adolescent sample. Exp Clin Psychopharmacol. 2022 Jun;30(3):287-299. doi: 10.1037/pha0000445. Epub 2021 Mar 22.
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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.
Sarah W. Feldstein Ewing, Ph. D. principal investigator
Assistant Professor UNM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Education in people with Alcoholism, run by University of New Mexico 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Mar 2024. 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. 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 was stopped early (reason given: Not an Applicable Clinical Trial (ACT).). Results are not available in the source record.
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?
Frequency of alcohol use (time frame: Change from baseline in frequency of alcohol use at 3 , 6 , & 12 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948700, which also lists 1 linked publication.
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 12 Mar 2024.