Trial Outcomes & Findings for The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens (NCT NCT03270943)
NCT ID: NCT03270943
Last Updated: 2021-05-18
Results Overview
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.
COMPLETED
NA
77 participants
weekly for up to 36 weeks
2021-05-18
Participant Flow
\*Note: the first two groups (Period 1: Intervention Refinement) were not randomized. Participants enrolled in those groups received the intervention, but the intervention and logistics were adapted based on participant feedback. Hence, these participants are not included in statistical analyses.
Participant milestones
| Measure |
Mindful Self-Compassion (MFY)
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Intervention Refinement
STARTED
|
6
|
9
|
|
Intervention Refinement
COMPLETED
|
6
|
6
|
|
Intervention Refinement
NOT COMPLETED
|
0
|
3
|
|
Randomized (Willingness to be)
STARTED
|
30
|
32
|
|
Randomized (Willingness to be)
COMPLETED
|
30
|
31
|
|
Randomized (Willingness to be)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
Baseline characteristics by cohort
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.81 years
STANDARD_DEVIATION 1.08 • n=5 Participants
|
15.63 years
STANDARD_DEVIATION 0.97 • n=7 Participants
|
15.72 years
STANDARD_DEVIATION 1.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
53 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a
|
52.7 T-score
STANDARD_DEVIATION 11.0 • n=5 Participants
|
58.1 T-score
STANDARD_DEVIATION 10.0 • n=7 Participants
|
55.5 T-score
STANDARD_DEVIATION 10.8 • n=5 Participants
|
PRIMARY outcome
Timeframe: weekly for up to 36 weeksPopulation: 3 participants with high baseline scores were excluded from the analysis procedure.
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. A score of 65 was used to indicate incident depression. The PROMIS measure used in lieu of the Short Mood and Feelings Questionnaire (SMFQ) due to increased measurement frequency. Higher scores indicate a greater level of depression.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=28 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=31 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Time to Incident Depression
|
36 weeks
Interval 0.71 to 36.0
|
18.86 weeks
Interval 2.86 to 36.0
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis utilized multiple imputations to account for missing data.
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized T-score transformation with a population mean of 50 and standard deviation of 10. Higher scores mean worse depression.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
Post Intervention
|
51.6 T-score
Standard Error 2.46
|
53.6 T-score
Standard Error 2.18
|
|
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
Baseline
|
52.7 T-score
Standard Error 2.02
|
58.1 T-score
Standard Error 1.77
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis utilized multiple imputations (chained).
The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome).
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Change in SMFQ Scores
Baseline
|
6.90 score on a scale
Standard Error 0.90
|
9.67 score on a scale
Standard Error 1.02
|
|
Change in SMFQ Scores
Post Intervention
|
6.26 score on a scale
Standard Error 1.35
|
7.95 score on a scale
Standard Error 1.05
|
SECONDARY outcome
Timeframe: Baseline, Week 8Population: Analysis utilizes multiple imputations.
.The BRS defines resiliency as the ability to "bounce back" and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Change in Brief Resiliency Scale (BRS) Scores
Baseline
|
3.03 score on a scale
Standard Error 0.13
|
3.05 score on a scale
Standard Error 0.16
|
|
Change in Brief Resiliency Scale (BRS) Scores
8 weeks
|
3.26 score on a scale
Standard Error 0.17
|
3.40 score on a scale
Standard Error 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 36 weeksPopulation: Longitudinal mixed effects model
The Short Mood and Feelings Questionnaire-Child Version (SMFQ-C) is a measure of the level of depressive symptoms among youth. This analysis utilized the 13-item youth version. Items are symptoms of depression experienced over the past 2 weeks. Each item is scored on a 3-point Likert scale as follows: "True" (0), "Sometimes" (1), and "Not True" (2) with total scores of 0-26. Lower scores at each time point indicate improvement. Higher scores indicate a greater level of depression (worse outcome). This measure was collected at baseline and at weeks 4, 8, 22, and 36.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Trajectory of SMFQ-C Depression Score Change
Baseline
|
6.9 score on a scale
Standard Error 1.0
|
9.8 score on a scale
Standard Error 1.0
|
|
Trajectory of SMFQ-C Depression Score Change
4 weeks
|
7.2 score on a scale
Standard Error 1.0
|
8.8 score on a scale
Standard Error 1.0
|
|
Trajectory of SMFQ-C Depression Score Change
8 weeks
|
6.9 score on a scale
Standard Error 1.0
|
7.9 score on a scale
Standard Error 1.0
|
|
Trajectory of SMFQ-C Depression Score Change
22 weeks
|
6.6 score on a scale
Standard Error 1.2
|
7.3 score on a scale
Standard Error 1.1
|
|
Trajectory of SMFQ-C Depression Score Change
36 weeks
|
5.4 score on a scale
Standard Error 1.1
|
8.6 score on a scale
Standard Error 1.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 36 weeksPopulation: Intent to treat analysis
The Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a: Raw Scores range from 0 - 32, with 0 being the lowest depression rating and 32 the highest depression rating. Analysis utilized t-score transformation with a population mean of 50 and standard deviation of 10. Higher scores indicate a greater level of depression. Model predicted mean at Baseline and 36 weeks is reported based on the longitudinal mixed effects model.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Trajectory of PROMIS Depression Score Change
Baseline
|
53.5 score on a scale
Standard Error 1.8
|
55.9 score on a scale
Standard Error 1.8
|
|
Trajectory of PROMIS Depression Score Change
36 weeks
|
47.5 score on a scale
Standard Error 2.0
|
53.9 score on a scale
Standard Error 2.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 36 weeksPopulation: Longitudinal mixed effects model
The BRS defines resiliency as the ability to "bounce back" and recover from stress; the items reflect a sense of personal agency. Six items are rated on a scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed and totals divided by the number of questions answered resulting in a mean score of 1-5. Higher scores at each time point indicate increasing resilience. This measure was collected at baseline and at weeks 4, 8, 22, and 36.
Outcome measures
| Measure |
Mindful Self-Compassion (MFY)
n=30 Participants
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=32 Participants
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
Trajectory of BRS Score Change
Baseline
|
3.03 score on a scale
Standard Error 0.15
|
3.05 score on a scale
Standard Error 0.15
|
|
Trajectory of BRS Score Change
4 weeks
|
3.22 score on a scale
Standard Error 0.15
|
3.10 score on a scale
Standard Error 0.15
|
|
Trajectory of BRS Score Change
8 weeks
|
3.36 score on a scale
Standard Error 0.16
|
3.28 score on a scale
Standard Error 0.15
|
|
Trajectory of BRS Score Change
22 weeks
|
3.01 score on a scale
Standard Error 0.18
|
3.41 score on a scale
Standard Error 0.17
|
|
Trajectory of BRS Score Change
36 weeks
|
3.65 score on a scale
Standard Error 0.17
|
3.38 score on a scale
Standard Error 0.16
|
Adverse Events
Mindful Self-Compassion (MFY)
Healthy Lifestyles (HLG)
Serious adverse events
| Measure |
Mindful Self-Compassion (MFY)
n=36 participants at risk
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
MFY: Mindful Self-Compassion course for teens
|
Healthy Lifestyles (HLG)
n=41 participants at risk
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
HLG: Healthy Lifestyles course for teens
|
|---|---|---|
|
General disorders
Hospitalization for Unknown Reason
|
2.8%
1/36 • Number of events 1 • Collected weekly from the beginning of the intervention through the 36-week follow-up.
|
0.00%
0/41 • Collected weekly from the beginning of the intervention through the 36-week follow-up.
|
Other adverse events
Adverse event data not reported
Additional Information
Christine Lathren, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place