ClinicalTrials.gg
CompletedNCT03367858MINAUpdated Nov 29, 2023Results posted

Motivational Interviewing and Neuroimaging With Adolescents

An interventional study of Motivational Interviewing (MI) and Brief Adolescent Mindfulness (BAM) in Alcohol Use, Unspecified, sponsored by University of Rhode Island. Completed at 1 site in United States. Open to participants aged 14 Years to 19 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by University of Rhode Island · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Jan 2017, registered Nov 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
204
Allocation
Randomized
Ages
14 Years to 19 Years
Sex
All
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Study summary

This is a randomized controlled trial to examine the impact of two brief interventions on adolescent and young adult alcohol use behaviors and related brain response. The interventions being compared are motivational interviewing (MI) and brief adolescent mindfulness (BAM).

02

Conditions studied

  • Alcohol Use, Unspecified

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03

In context

Alcohol Drinking

701 studies on the registry are indexed under Alcohol Drinking; 133 are open to participants now.

This study's enrollment of 204 is above the median of 122 across 607 interventional studies indexed under Alcohol Drinking.

Browse Alcohol Drinking studies →

Lead sponsor

University of Rhode Island is the lead sponsor of 34 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • within the specified age range
  • >= 1 past two month binge drinking episode
  • right-handed
  • proficient in English
  • agree to be contacted for the 3, 6, and 12 month follow ups
  • of a parent/guardian, if under 18 years old
  • informed assent/consent of participating youth

Exclusion criteria

Exclusion Criteria:

  • > 3 past-month instances of non-nicotine and/or non-cannabis substance use (e.g., methamphetamine)
  • evidence of brain injury/illness or neurological disorder including psychosis
  • lifetime loss of consciousness >= 2 min
  • unremovable metal on/in body, or other functional magnetic resonance imaging (fMRI) (e.g., pregnancy)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
204 participants (actual)

Study arms

  • Experimental
    Motivational Interviewing (MI)

    This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.

    Behavioral: Motivational Interviewing (MI)

  • Active comparator
    Brief Adolescent Mindfulness (BAM)

    This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.

    Behavioral: Brief Adolescent Mindfulness (BAM)

Interventions

  • BehavioralMotivational Interviewing (MI)

    Motivational interviewing introduced a conversation about alcohol use, and the personally-experienced consequences of problem drinking. The MI sessions explored youths' stories around their substance use, the factors in youths' lives that support problem drinking (e.g., what they like about drinking), and the consequences of their recent or previous problem drinking (e.g., getting in trouble). Youth were provided personalized feedback about how their problem drinking compared to age-matched norms in the U.S. The ultimate goal of the MI sessions was to engage youth in a thoughtful conversation about their problem drinking with an eye to bolstering and supporting youths' own inherent drive for behavior change.

  • BehavioralBrief Adolescent Mindfulness (BAM)

    Brief Adolescent Mindfulness introduced a conversation about what mindfulness is, and ways that it might be personally-relevant to adolescents' current experiences. This manualized treatment introduced concepts of eastern thought in a manner articulated to adolescents. Treatment included a discussion of factors in the youth's life that could be positively impacted by using or engaging mindful approaches (e.g., current experiences of stress) and a link to how mindful approaches might be applicable or relevant to the adolescent's problem drinking. The ultimate goal was to engage youth in a thoughtful conversation about BAM and how eastern thought and mindful approaches could unburden some aspects of their current lived experiences.

06

What researchers measure

Primary outcomes

  1. Alcohol-related Problems

    Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.

    Time frame: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported

07

Results

Posted Nov 29, 2023

Participant flow

Intervention + Baseline Scan
Participant flow — Intervention + Baseline Scan
MilestoneMotivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)
Started101103
Completed97101
Not completed42
Withdrew: Unable to adhere to session timeline22
Withdrew: Withdrawal by subject20
3 Month Follow Up
Participant flow — 3 Month Follow Up
MilestoneMotivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)
Started97101
Completed8187
Not completed1614
Withdrew: Lost to follow-up83
Withdrew: Moved out of study area26
Withdrew: Unable to adhere to session timeline13
Withdrew: Mri contraindication21
Withdrew: Incarcerated01
Withdrew: Withdrawal by subject30
6 Month Follow Up
Participant flow — 6 Month Follow Up
MilestoneMotivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)
Started8187
Completed7684
Not completed53
Withdrew: Lost to follow-up52
Withdrew: Withdrawal by subject01
12 Month Follow Up
Participant flow — 12 Month Follow Up
MilestoneMotivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)
Started8187
Completed7883
Not completed34
Withdrew: Lost to follow-up33
Withdrew: Withdrawal by subject01

Outcome measures

PrimaryAlcohol-related Problems

Rutgers Alcohol Problems Index (RAPI) to assess alcohol-related problems. Minimum individual value = 0; maximum individual value = 92. Higher scores mean more alcohol-related problems.

Time frame:
assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
Reported as:
Mean · units on a scale
Alcohol-related Problems
units on a scaleMotivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)
Alcohol-related Problems2.75 ± 0.454.88 ± 0.75
Statistical analysis
  • Motivational Interviewing (MI) vs Brief Adolescent Mindfulness (BAM) · ANCOVA · p = .0173 (At 12 month follow up.)

Adverse events

Collected over Duration of participant participation (baseline through 12 month follow up).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Motivational Interviewing (MI)0/101 (0%)0/101 (0%)0/101 (0%)
Brief Adolescent Mindfulness (BAM)0/103 (0%)0/103 (0%)0/103 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
Mean18.83 ± 1.0318.54 ± 1.0818.68 ± 1.06
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
Female6362125
Male333467
Genderqueer / Gender neutral4610
Transgender112
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
Hispanic or Latino211334
Not Hispanic or Latino7989168
Unknown or Not Reported112
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
American Indian or Alaska Native213
Asian81220
Native Hawaiian or Other Pacific Islander235
Black or African American246
White7164135
More than one race111526
Unknown or Not Reported549
Region of Enrollment
Region of Enrollment(participants)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
United States101103204
Alcohol-related Problems
Alcohol-related Problems(units on a scale)Motivational Interviewing (MI)Brief Adolescent Mindfulness (BAM)Total
Mean8.98 ± 13.086.13 ± 6.607.54 ± 10.40
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Study locations

1 site
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
09

References and documents

Publications

  • Dash GF, Chung T, Yang M, Bryan AD, Hudson KA, Feldstein Ewing SW. Examining the influence of adolescent:provider alliance on youth hazardous drinking: Findings from a randomized controlled trial. Addict Behav. 2023 Jan;136:107499. doi: 10.1016/j.addbeh.2022.107499. Epub 2022 Sep 21. PubMed 36166981 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2017 to primary completion in Jan 2020, 36 months.

Results were first posted in Nov 2023, 3 years 10 months after primary completion.

Of 328 non-industry interventional studies with no phase under Alcohol Drinking, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's 36 months is above that.

Counting every sponsor, half of 336 studies reached it within 24 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Dec 11, 2017
StartActual
Jan 2017
Primary completionActual
Jan 21, 2020
CompletionActual
Jan 21, 2020
Results first posted
Nov 29, 2023
Last update
Nov 29, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03367858
Lead sponsor
University of Rhode Island
Responsible party
Sarah Feldstein Ewing (Professor, University of Rhode Island) — Principal investigator
First posted
Dec 11, 2017
Start date
Jan 2017
Primary completion
Jan 21, 2020
Completion
Jan 21, 2020
Results posted
Nov 29, 2023
Last update
Nov 29, 2023

Study contacts

Sarah Feldstein Ewing, PhD
principal investigator · University of Rhode Island

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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