An interventional study of MFY and HLG in Depression Mild, Resilience, Psychological and Adolescent Behavior, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-18.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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).
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.
305 studies on the registry are indexed under Adolescent Behavior; 47 are open to participants now.
This study's enrollment of 77 is below the median of 172 across 256 interventional studies indexed under Adolescent Behavior.
Browse Adolescent Behavior studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
Behavioral: MFY
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
Behavioral: HLG
Mindful Self-Compassion course for teens
Healthy Lifestyles course for teens
Time to Incident Depression
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
Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
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
Change in SMFQ Scores
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
Change in Brief Resiliency Scale (BRS) Scores
.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
Trajectory of SMFQ-C Depression Score Change
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
Trajectory of PROMIS Depression Score Change
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
Trajectory of BRS Score Change
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
| Milestone | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Started | 6 | 9 |
| Completed | 6 | 6 |
| Not completed | 0 | 3 |
| Milestone | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Started | 30 | 32 |
| Completed | 30 | 31 |
| Not completed | 0 | 1 |
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.
| weeks | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Time to Incident Depression | 36 (0.71 to 36) | 18.86 (2.86 to 36) |
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.
| T-score | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Baseline | 52.7 ± 2.02 | 58.1 ± 1.77 |
| Post Intervention | 51.6 ± 2.46 | 53.6 ± 2.18 |
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).
| score on a scale | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Baseline | 6.90 ± 0.90 | 9.67 ± 1.02 |
| Post Intervention | 6.26 ± 1.35 | 7.95 ± 1.05 |
.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.
| score on a scale | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Baseline | 3.03 ± 0.13 | 3.05 ± 0.16 |
| 8 weeks | 3.26 ± 0.17 | 3.40 ± 0.19 |
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.
| score on a scale | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| 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 |
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.
| score on a scale | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Baseline | 53.5 ± 1.8 | 55.9 ± 1.8 |
| 36 weeks | 47.5 ± 2.0 | 53.9 ± 2.0 |
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.
| score on a scale | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| 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 |
Collected over Collected weekly from the beginning of the intervention through the 36-week follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mindful Self-Compassion (MFY) | 0/36 (0%) | 1/36 (2.8%) | 0/36 (0%) |
| Healthy Lifestyles (HLG) | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| Event | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) |
|---|---|---|
| Hospitalization for Unknown ReasonGeneral disorders | 1/36 | 0/41 |
Includes only the randomized population (Period 2: Randomized (Willingness to be)) who attended at least one intervention class.
| Age, Continuous(years) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| Mean | 15.81 ± 1.08 | 15.63 ± 0.97 | 15.72 ± 1.02 |
| Sex: Female, Male(Participants) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 9 | 10 | 19 |
| Ethnicity (NIH/OMB)(Participants) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 5 | 7 |
| Not Hispanic or Latino | 27 | 26 | 53 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 4 | 3 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 4 | 7 |
| White | 19 | 21 | 40 |
| More than one race | 3 | 3 | 6 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Region of Enrollment(Participants) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| United States | 30 | 32 | 62 |
| Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a(T-score) | Mindful Self-Compassion (MFY) | Healthy Lifestyles (HLG) | Total |
|---|---|---|---|
| Mean | 52.7 ± 11.0 | 58.1 ± 10.0 | 55.5 ± 10.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Jun 2020, 32 months.
Results were first posted in May 2021, 11 months after primary completion.
Of 195 non-industry interventional studies with no phase under Adolescent Behavior, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 43. This study's 32 months is above that.
Counting every sponsor, half of 198 studies reached it within 20 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of North Carolina, Chapel Hill →