Trial Outcomes & Findings for Pilot Study on Training Emerging Adults Skills in Navigating College (NCT NCT05560425)
NCT ID: NCT05560425
Last Updated: 2024-11-26
Results Overview
Participant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
10 weeks
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
Navigating College (NC) Training (Control Group)
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); Hungry, Angry, Lonely, Tired (HALT), gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
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|---|---|---|
|
Overall Study
STARTED
|
7
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study on Training Emerging Adults Skills in Navigating College
Baseline characteristics by cohort
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=9 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
|
Total
n=16 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
18.25 years
STANDARD_DEVIATION 0.38 • n=5 Participants
|
18.00 years
STANDARD_DEVIATION 0 • n=7 Participants
|
18.06 years
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeksParticipant retention will be measured by the percentage of enrolled participants remaining in the study after 6 visits.
Outcome measures
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=9 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
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|---|---|---|
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Participant Retention
|
85.71 percentage of participants
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88.89 percentage of participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Only 7 out of 9 participants in the KM Training group were analyzed because two participants dropped out of the study prior to completing the full duration of the training.
To determine participant compliance with training skills learned during each of the 4 virtual visits, the average number of journal entries logged during the 4 weeks of training, for each group, is calculated as a total score (6 times/week x 4 weeks = 24). Scores range from 0 to 24, with higher scores indicating greater compliance with independent training.
Outcome measures
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=7 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
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|---|---|---|
|
Compliance With Independent Training of Skills
|
10.43 score on a scale
Standard Deviation 6.70
|
9.14 score on a scale
Standard Deviation 6.18
|
SECONDARY outcome
Timeframe: 1 weekThe Credibility subscale of the Credibility/Expectancy Questionnaire (CEQ) measures the the credibility of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Three items are each scored on a range from 0-9 and averaged together for a credibility rating, with high scores indicating greater perceived credibility of the intervention.
Outcome measures
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=9 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
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|---|---|---|
|
Average CEQ Ratings - Credibility Subscale
|
15.29 score on a scale
Standard Deviation 2.50
|
13.44 score on a scale
Standard Deviation 2.70
|
SECONDARY outcome
Timeframe: 1 weekThe Expectancy subscale of the Credibility/Expectancy Questionnaire (CEQ) measures the the expectancy of an intervention in clinical studies. The word "therapy" is replaced with "intervention" and modified to reflect the intent of the intervention (i.e., to improve skills in navigating college). Three items are each scored on a range from 0-9 and averaged together for an expectancy rating, with high scores indicating greater perceived expectancy of positive outcomes of the intervention.
Outcome measures
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=9 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
|
|---|---|---|
|
Average CEQ Ratings - Expectancy Subscale
|
13.29 score on a scale
Standard Deviation 7.25
|
14.00 score on a scale
Standard Deviation 5.34
|
SECONDARY outcome
Timeframe: Baseline, Week 6Population: Change scores could not be calculated for all participants for each subscale in the Navigating College (NC) Training (Control Group) due to missing data. Week 6 data were not collected for 2 participants in the Koru Mindfulness (KM) Training (Study Group).
The Depression, Anxiety and Stress Scale-21 (DASS-21) is composed of three self-report scales that measure depression, anxiety and stress. Items are rated on a Likert-type scale (0=Did not apply to me at all, to 3=Applied to me very much, or most of the time). Scores for the three subscales are calculated by summing the scores for the relevant items. The severity rating for Depression are Normal: 0-4, Mild: 5-6, Moderate: 7-10, Severe: 11-13, and Extremely Severe: 14-21; for Stress the ratings are Normal: 0-7, Mild: 8-9, Moderate: 10-12, Severe: 13-16, and Extremely Severe 17-21; and for Anxiety the ratings are Normal: 0-3, Mild: 4-5, Moderate: 6-7, Severe: 8-9, and Extremely Severe: 10-21. The total DASS-21 score is calculated by summing all three subscales, with a range from 0-63. For all scales, higher scores indicate greater emotional distress.
Outcome measures
| Measure |
Navigating College (NC) Training (Control Group)
n=7 Participants
With topics discussed from the Freshman Survival Guide book, this training provides a closely matched active control group for KM Training. The training consists of four weekly 75-minute classes delivered online through Zoom. Each class consists of lecture and group discussions on topics related to navigating college. Topics discussed during each training visit include: habits, roommate issues, homesickness, the internet (week 1); strategies when sinking, study skills, getting involved, habit formation (week 2); HALT, gateway habit (week 3); and academic success tips, taking notes, and procrastination (week 4). Participants are instructed to journal about learned information and skills for 10 minutes/day.
|
Koru Mindfulness (KM) Training (Study Group)
n=7 Participants
The Koru Basic curriculum consists of four weekly interactive 75-minute classes delivered online through Zoom. Each class consists of an overview of 2-3 skills, group practice of the skills, and group reflection. Topics discussed during each training visit include: belly breathing, dynamic breathing, body scan (week 1); walking meditation, gatha (week 2); guided imagery, labeling thoughts (week 3); eating meditation, and labeling feelings (week 4). Participants are instructed to practice a skill for 10 minutes/day and log any reflection on that practice using the Koru phone application.
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|---|---|---|
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Mean Change in Emotional Distress Scores
DASS-21 Total score
|
8.8 score on a scale
Standard Error 7.1
|
4.6 score on a scale
Standard Error 6.0
|
|
Mean Change in Emotional Distress Scores
DASS-21 Depression score
|
3.2 score on a scale
Standard Error 2.9
|
2.6 score on a scale
Standard Error 2.5
|
|
Mean Change in Emotional Distress Scores
DASS-21 Anxiety score
|
2.4 score on a scale
Standard Error 0.6
|
0.6 score on a scale
Standard Error 3.0
|
|
Mean Change in Emotional Distress Scores
DASS-21 Stress score
|
3.2 score on a scale
Standard Error 2.1
|
1.4 score on a scale
Standard Error 1.8
|
SECONDARY outcome
Timeframe: 5 weeksPopulation: Due to the time commitment burden on participants, data were not collected for this outcome.
Feedback will be collected the same day as each training visit, using a simple survey designed on Qualtrics.
Outcome measures
Outcome data not reported
Adverse Events
Navigating College (NC) Training (Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Koru Mindfulness (KM) Training (Study Group)
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
Elena Vidrascu, PhD, MSc
University of North Carolina at Chapel Hill
Phone: 919-843-9193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place