Trial Outcomes & Findings for A Study of Adolescents Undergoing a Mindfulness Training During COVID-19 (NCT NCT04548544)
NCT ID: NCT04548544
Last Updated: 2024-12-11
Results Overview
Change in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 100. Higher scores represent higher levels of emotional problems.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Baseline/randomization and 12 weeks after baseline/randomization
Results posted on
2024-12-11
Participant Flow
Participant milestones
| Measure |
TARA Training
Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
|
Control
passive control
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
9
|
|
Overall Study
COMPLETED
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Adolescents Undergoing a Mindfulness Training During COVID-19
Baseline characteristics by cohort
| Measure |
TARA Training
n=12 Participants
Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
|
Control
n=9 Participants
passive control
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.0 years
STANDARD_DEVIATION 1.0 • n=99 Participants
|
15.7 years
STANDARD_DEVIATION 1.4 • n=107 Participants
|
15.9 years
STANDARD_DEVIATION 1.2 • n=206 Participants
|
|
Sex/Gender, Customized
male
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex/Gender, Customized
female
|
6 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Sex/Gender, Customized
other
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
SDQ emotional symptoms
|
56.9 units on a scale
STANDARD_DEVIATION 10.0 • n=99 Participants
|
57.3 units on a scale
STANDARD_DEVIATION 10.9 • n=107 Participants
|
57.1 units on a scale
STANDARD_DEVIATION 10.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline/randomization and 12 weeks after baseline/randomizationChange in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 100. Higher scores represent higher levels of emotional problems.
Outcome measures
| Measure |
TARA Training
n=12 Participants
Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
|
Control
n=9 Participants
passive control
|
|---|---|---|
|
Change in SDQ Emotional Problems
|
2.08 units on a scale
Standard Deviation 5.53
|
-4.49 units on a scale
Standard Deviation 4.71
|
Adverse Events
TARA Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
Olga Tymofiyeva
University of California, San Francisco
Phone: 415-514-4870
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place