The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03270943
• Collaborator: National Center for Complementary and Integrative Health (NCCIH) (NIH)
• Enrollment: 77
• Location: 1
• Arms: 2
• Actual Duration (Months): 32.9
• Patients Per Site Per Month: 2.3

Study Details

Study Description

Brief Summary

The rate of depression increases markedly over the course of adolescence. Adolescents struggling with depression are often set on a maladaptive behavior trajectory which may lead to academic challenges, substance abuse, risky sexual behavior, impairment in relationship building, and suicidality. The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. The study proposes to refine and test the feasibility of a mindfulness-based self-compassion training program for adolescents who are experiencing subsyndromal depression, comparing it with a "healthy lifestyles" group program as a comparison attention-control for the treatment intervention. Secondarily, the study will explore the impact of these programs on measures of psychopathology and well-being (i.e. depressive symptoms and resilience).

Condition or Disease	Intervention/Treatment	Phase
Depression Mild; Resilience, Psychological; Adolescent Behavior	Behavioral: MFY; Behavioral: HLG	N/A

Detailed Description

Depressive symptoms are common in adolescents, with 20-25% of adolescents experiencing a depressive episode before they graduate high school, and implications into adulthood. Since depression often first appears in adolescence and unsuccessful treatment of adolescent depression increases the risk of chronic or recurrent depression in adulthood, managing depression symptoms at this critical stage of development can benefit mental health and functioning throughout the lifespan. Preliminary studies have indicated that a mindful self-compassion program is a promising intervention to prevent depression and improve wellbeing in at-risk teens.

The S.M.A.R.T Project (Stress Management and Resilience Training for Teens) is designed to learn about mood in teens, and whether emotional well-being can be improved with an 8 week class. In this study, 80 adolescents ages 14-17 ,with subsyndromal depression, will be randomized to either the 8-week mindful self-compassion intervention or the 8-week healthy lifestyles control program, followed by 6 monthly continuation sessions. Feasibility of the research protocol and of the program elements will be assessed. Focus group feedback will also inform program modifications and refinement. Additionally, baseline, mid-intervention, and 3- and 6-months post intervention measurements of depression, resilience, and other related psychosocial measures will allow preliminary exploration of the impact of each program on outcomes.

Study Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.After the first two intervention-refinement groups, participants will be randomized to one of two groups: a mindful self-compassion program or an active attention control program. Randomization will be stratified by gender. As soon as 20 eligible adolescents qualify for enrollment, they will be allocated to either the MFY or healthy lifestyle groups, using a specially-designed computer program which utilizes a random number generator with a permuted block design to ensure that the number of subjects allocated to the two arms over time are equal and to conceal the allocation. This will continue through 3 additional cohorts of adolescents for a total sample size of 80 (including test groups). Randomization is designed to assess feasibility of the randomization plan, in addition to general feasibility issues of the delivery of the educational programs.
• Masking: Single (Outcomes Assessor)
• Masking Description: The nature of the interventions tested in this study does not allow for masking of subjects, instructors, or other personnel involved in program delivery. To preserve unbiased outcome assessments, study personnel involved in clinical assessments or data analysis will be masked with respect to group assignment. To minimize differences in subject expectancy, the programs will be described to participants as two programs, both of which have been previously found to be beneficial to teens.
• Primary Purpose: Prevention
• Official Title: Making Friends With Yourself: a Depression Prevention Program for Adolescents
• Actual Study Start Date: Sep 5, 2017
• Actual Primary Completion Date: Jun 3, 2020
• Actual Study Completion Date: Jun 3, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: MFY; Mindful Self-Compassion course for teens
Active Comparator: Healthy Lifestyles (HLG) An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.	Behavioral: HLG; Healthy Lifestyles course for teens

Outcome Measures

Primary Outcome Measures

1. Time to Incident Depression [weekly for up to 36 weeks]

   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.

Secondary Outcome Measures

1. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores [Baseline, Week 8]

   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.

2. Change in SMFQ Scores [Baseline, Week 8]

   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).

3. Change in Brief Resiliency Scale (BRS) Scores [Baseline, Week 8]

   .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.

Other Outcome Measures

1. Trajectory of SMFQ-C Depression Score Change [Up to 36 weeks]

   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.

2. Trajectory of PROMIS Depression Score Change [up to 36 weeks]

   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.

3. Trajectory of BRS Score Change [up to 36 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 14 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Adolescents age14-17 (inclusive) in high school (may turn 18 after enrollment).

• Score of at least 6 on the Quick Inventory Depressive Symptomatology (QIDS). Potential participants must be pre-screened with the QIDS assessment

• Clinical mental health assessment based on the Diagnostic Interview Schedule for Children-IV (DISC-IV) to screen for serious psychiatric illness, including current major depression

• Able to read and communicate in English

• Willing to be randomized to one of the two arms;

• Able to attend 8 weekly, 1.75 hour sessions, as well as complete self-report measures and homework

• Have access to a computer or other internet-enabled device.

Exclusion Criteria:

• Score of at least 6 on the QIDS (pre-screening);

• Suicidality or major depression as determined by Study Psychologist;

• Inability to speak, write, and read English;

• Active substance abuse, defined as active treatment for substance abuse, legal consequences/school suspensions associated with substance use, or ongoing family conflict associated with substance use;

• History of bipolar disorder, schizophrenia, severe autism, or psychiatric hospitalization within the past 2 years;

• Unable or unwilling to attend or participate in group sessions and/or self-report assessments;

• Current or prior participation in another intervention to address depression or psychiatric conditions;

• Prior formal training in mindfulness, such as a mindfulness course.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Christine Lathren, MD, MPH	Chapel Hill	North Carolina	United States	27599-7200

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Susan Gaylord, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 1, 2021

More Information

Publications

• Bluth K, Gaylord SA, Campo RA, Mullarkey MC, Hobbs L. Making Friends With Yourself: A Mixed Methods Pilot Study of a Mindful Self-Compassion Program for Adolescents. Mindfulness (N Y). 2016 Mar 1;7(2):479-492. Epub 2015 Dec 19.
• Bluth K, Roberson PN, Gaylord SA, Faurot KR, Grewen KM, Arzon S, Girdler SS. Does Self-compassion Protect Adolescents from Stress? J Child Fam Stud. 2016 Apr;25(4):1098-1109. Epub 2015 Oct 23.
• Bluth K, Roberson PN, Gaylord SA. A Pilot Study of a Mindfulness Intervention for Adolescents and the Potential Role of Self-Compassion in Reducing Stress. Explore (NY). 2015 Jul-Aug;11(4):292-5. doi: 10.1016/j.explore.2015.04.005. Epub 2015 Apr 28.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03270943
• Other Study ID Numbers: 16-1864; R34AT008822-01A1
• First Posted: Sep 1, 2017
• Last Update Posted: May 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depression

Study Results

Participant Flow

Pre-assignment Detail	*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.

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Period Title: Intervention Refinement
STARTED	6	9
COMPLETED	6	6
NOT COMPLETED	0	3
Period Title: Intervention Refinement
STARTED	30	32
COMPLETED	30	31
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	30	32	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	15.81 (1.08)	15.63 (0.97)	15.72 (1.02)
Sex: Female, Male (Count of Participants)
Female	21 70%	22 68.8%	43 69.4%
Male	9 30%	10 31.3%	19 30.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 6.7%	5 15.6%	7 11.3%
Not Hispanic or Latino	27 90%	26 81.3%	53 85.5%
Unknown or Not Reported	1 3.3%	1 3.1%	2 3.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 13.3%	3 9.4%	7 11.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 10%	4 12.5%	7 11.3%
White	19 63.3%	21 65.6%	40 64.5%
More than one race	3 10%	3 9.4%	6 9.7%
Unknown or Not Reported	1 3.3%	1 3.1%	2 3.2%
Region of Enrollment (Count of Participants)
United States	30 100%	32 100%	62 100%
Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a (T-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [T-score]	52.7 (11.0)	58.1 (10.0)	55.5 (10.8)

Outcome Measures

1. Primary Outcome

Title	Time to Incident Depression
Description	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.
Time Frame	weekly for up to 36 weeks

Outcome Measure Data

Analysis Population Description

3 participants with high baseline scores were excluded from the analysis procedure.

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	28	31
Median (Inter-Quartile Range) [weeks]	36	18.86

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindful Self-Compassion (MFY), Healthy Lifestyles (HLG)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.02
	Comments
	Method	Log Rank
	Comments

2. Secondary Outcome

Title	Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
Description	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.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Analysis utilized multiple imputations to account for missing data.

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	52.7 (2.02)	58.1 (1.77)
Post Intervention	51.6 (2.46)	53.6 (2.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindful Self-Compassion (MFY)
	Comments
	Type of Statistical Test	Other
	Comments	within group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.01
	Confidence Interval	(2-Sided) 95%; -6.06 to 3.84
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.21
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Healthy Lifestyles (HLG)
	Comments
	Type of Statistical Test	Other
	Comments	within group
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.46
	Confidence Interval	(2-Sided) 95%; -8.70 to -0.22
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.05
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

3. Secondary Outcome

Title	Change in SMFQ Scores
Description	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).
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Analysis utilized multiple imputations (chained).

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	6.90 (0.90)	9.67 (1.02)
Post Intervention	6.26 (1.35)	7.95 (1.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindful Self-Compassion (MFY)
	Comments
	Type of Statistical Test	Other
	Comments	within group change
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 95%; -2.72 to 0.2
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.99
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Healthy Lifestyles (HLG)
	Comments
	Type of Statistical Test	Other
	Comments	within group change
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-1.72
	Confidence Interval	(2-Sided) 95%; -3.60 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.91
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

4. Secondary Outcome

Title	Change in Brief Resiliency Scale (BRS) Scores
Description	.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.
Time Frame	Baseline, Week 8

Outcome Measure Data

Analysis Population Description

Analysis utilizes multiple imputations.

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	3.03 (0.13)	3.05 (0.16)
8 weeks	3.26 (0.17)	3.40 (0.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mindful Self-Compassion (MFY)
	Comments
	Type of Statistical Test	Other
	Comments	Within group change
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.23
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.61
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Healthy Lifestyles (HLG)
	Comments
	Type of Statistical Test	Other
	Comments	within group change
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.35
	Confidence Interval	(2-Sided) 95%; 0.07 to 0.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments	Difference between score at 8 weeks and score at baseline.

5. Other Pre-specified Outcome

Title	Trajectory of SMFQ-C Depression Score Change
Description	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.
Time Frame	Up to 36 weeks

Outcome Measure Data

Analysis Population Description

Longitudinal mixed effects model

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	6.9 (1.0)	9.8 (1.0)
4 weeks	7.2 (1.0)	8.8 (1.0)
8 weeks	6.9 (1.0)	7.9 (1.0)
22 weeks	6.6 (1.2)	7.3 (1.1)
36 weeks	5.4 (1.1)	8.6 (1.1)

6. Other Pre-specified Outcome

Title	Trajectory of PROMIS Depression Score Change
Description	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.
Time Frame	up to 36 weeks

Outcome Measure Data

Analysis Population Description

Intent to treat analysis

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	53.5 (1.8)	55.9 (1.8)
36 weeks	47.5 (2.0)	53.9 (2.0)

7. Other Pre-specified Outcome

Title	Trajectory of BRS Score Change
Description	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.
Time Frame	up to 36 weeks

Outcome Measure Data

Analysis Population Description

Longitudinal mixed effects model

Arm/Group Title	Mindful Self-Compassion (MFY)	Healthy Lifestyles (HLG)
Arm/Group Description	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	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
Measure Participants	30	32
Baseline	3.03 (0.15)	3.05 (0.15)
4 weeks	3.22 (0.15)	3.10 (0.15)
8 weeks	3.36 (0.16)	3.28 (0.15)
22 weeks	3.01 (0.18)	3.41 (0.17)
36 weeks	3.65 (0.17)	3.38 (0.16)

Adverse Events

Time Frame	Collected weekly from the beginning of the intervention through the 36-week follow-up.
Arm/Group Title	Mindful Self-Compassion (MFY)		Healthy Lifestyles (HLG)
Arm/Group Description	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		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
All Cause Mortality
	Mindful Self-Compassion (MFY)		Healthy Lifestyles (HLG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/41 (0%)
Serious Adverse Events
	Mindful Self-Compassion (MFY)		Healthy Lifestyles (HLG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/36 (2.8%)		0/41 (0%)
General disorders
Hospitalization for Unknown Reason	1/36 (2.8%)	1	0/41 (0%)	0
Other (Not Including Serious) Adverse Events
	Mindful Self-Compassion (MFY)		Healthy Lifestyles (HLG)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/36 (0%)		0/41 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.