Trial Outcomes & Findings for Motivational Interviewing and Neuroimaging With Adolescents (NCT NCT03367858)
NCT ID: NCT03367858
Last Updated: 2023-11-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reported
Results posted on
2023-11-29
Participant Flow
Participant milestones
| Measure |
Motivational Interviewing (MI)
This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.
|
Brief Adolescent Mindfulness (BAM)
This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.
|
|---|---|---|
|
Intervention + Baseline Scan
STARTED
|
101
|
103
|
|
Intervention + Baseline Scan
COMPLETED
|
97
|
101
|
|
Intervention + Baseline Scan
NOT COMPLETED
|
4
|
2
|
|
3 Month Follow Up
STARTED
|
97
|
101
|
|
3 Month Follow Up
COMPLETED
|
81
|
87
|
|
3 Month Follow Up
NOT COMPLETED
|
16
|
14
|
|
6 Month Follow Up
STARTED
|
81
|
87
|
|
6 Month Follow Up
COMPLETED
|
76
|
84
|
|
6 Month Follow Up
NOT COMPLETED
|
5
|
3
|
|
12 Month Follow Up
STARTED
|
81
|
87
|
|
12 Month Follow Up
COMPLETED
|
78
|
83
|
|
12 Month Follow Up
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Motivational Interviewing (MI)
This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.
|
Brief Adolescent Mindfulness (BAM)
This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.
|
|---|---|---|
|
Intervention + Baseline Scan
Unable to adhere to session timeline
|
2
|
2
|
|
Intervention + Baseline Scan
Withdrawal by Subject
|
2
|
0
|
|
3 Month Follow Up
Lost to Follow-up
|
8
|
3
|
|
3 Month Follow Up
Moved out of study area
|
2
|
6
|
|
3 Month Follow Up
Unable to adhere to session timeline
|
1
|
3
|
|
3 Month Follow Up
MRI contraindication
|
2
|
1
|
|
3 Month Follow Up
Incarcerated
|
0
|
1
|
|
3 Month Follow Up
Withdrawal by Subject
|
3
|
0
|
|
6 Month Follow Up
Lost to Follow-up
|
5
|
2
|
|
6 Month Follow Up
Withdrawal by Subject
|
0
|
1
|
|
12 Month Follow Up
Lost to Follow-up
|
3
|
3
|
|
12 Month Follow Up
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Motivational Interviewing and Neuroimaging With Adolescents
Baseline characteristics by cohort
| Measure |
Motivational Interviewing (MI)
n=101 Participants
This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.
|
Brief Adolescent Mindfulness (BAM)
n=103 Participants
This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
18.83 years
STANDARD_DEVIATION 1.03 • n=5 Participants
|
18.54 years
STANDARD_DEVIATION 1.08 • n=7 Participants
|
18.68 years
STANDARD_DEVIATION 1.06 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
63 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Genderqueer / Gender neutral
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Transgender
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
21 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
101 participants
n=5 Participants
|
103 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Alcohol-related Problems
|
8.98 units on a scale
STANDARD_DEVIATION 13.08 • n=5 Participants
|
6.13 units on a scale
STANDARD_DEVIATION 6.60 • n=7 Participants
|
7.54 units on a scale
STANDARD_DEVIATION 10.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at baseline, and 3-, 6-, and 12-month post-treatment follow ups; 12-month follow up reportedPopulation: Youth with full problem drinking data at all follow up time points were included in treatment outcome analyses.
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.
Outcome measures
| Measure |
Motivational Interviewing (MI)
n=77 Participants
This randomly assigned group receives two 60-minute 1:1 sessions of motivational interviewing.
Motivational 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.
|
Brief Adolescent Mindfulness (BAM)
n=86 Participants
This randomly assigned group receives two 60-minute 1:1 sessions of Brief Adolescent Mindfulness.
Brief 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.
|
|---|---|---|
|
Alcohol-related Problems
|
2.75 units on a scale
Standard Error 0.45
|
4.88 units on a scale
Standard Error 0.75
|
Adverse Events
Motivational Interviewing (MI)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Adolescent Mindfulness (BAM)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place