Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R34AT008822-01A1 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindful Self-Compassion (MFY) | Experimental | An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. |
|
| Healthy Lifestyles (HLG) | Active Comparator | An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MFY | Behavioral | Mindful Self-Compassion course for teens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | weekly for up to 36 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Gaylord, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christine Lathren, MD, MPH | Chapel Hill | North Carolina | 27599-7200 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26005198 | Background | 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. | |
| 27110301 | Background | 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. doi: 10.1007/s12671-015-0476-6. Epub 2015 Dec 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
*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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Intervention Refinement |
| |||||||||||||
| Randomized (Willingness to be) |
|
Includes only the randomized population (Period 2: Randomized (Willingness to be)) who attended at least one intervention class.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Healthy Lifestyles (HLG) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 3 participants with high baseline scores were excluded from the analysis procedure. | Posted | Median | Inter-Quartile Range | weeks | weekly for up to 36 weeks |
|
Collected weekly from the beginning of the intervention through the 36-week follow-up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Unknown Reason | General disorders | Systematic Assessment | Specific cause for hospitalization undisclosed |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Lathren, MD, MPH | University of North Carolina at Chapel Hill | 919-966-8586 | lathren@email.unc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 1, 2021 | Mar 25, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000294 | Adolescent Behavior |
| ID | Term |
|---|---|
| D001519 | Behavior |
Not provided
Not provided
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.
Not provided
Not provided
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.
| HLG |
| Behavioral |
Healthy Lifestyles course for teens |
|
| 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). | 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. | Baseline, Week 8 |
| 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. | 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. | up to 36 weeks |
| 26997856 | Background | 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. doi: 10.1007/s10826-015-0307-3. Epub 2015 Oct 23. No abstract available. |
| 38010232 | Derived | Bluth K, Lathren C, Park J, Lynch C, Curry J, Harris-Britt A, Gaylord S. Feasibility, acceptability, and depression outcomes of a randomized controlled trial of Mindful Self-Compassion for Teens (MSC-T) for adolescents with subsyndromal depression. J Adolesc. 2024 Feb;96(2):322-336. doi: 10.1002/jad.12277. Epub 2023 Nov 27. |
| NOT COMPLETED |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric short form depression 8a | 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. | Mean | Standard Deviation | T-score |
|
| OG001 | 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 |
|
|
|
| Secondary | 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. | Analysis utilized multiple imputations to account for missing data. | Posted | Mean | Standard Error | T-score | Baseline, Week 8 |
|
|
|
|
| Secondary | 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). | Analysis utilized multiple imputations (chained). | Posted | Mean | Standard Error | score on a scale | Baseline, Week 8 |
|
|
|
|
| Secondary | 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. | Analysis utilizes multiple imputations. | Posted | Mean | Standard Error | score on a scale | Baseline, Week 8 |
|
|
|
|
| Other Pre-specified | 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. | Longitudinal mixed effects model | Posted | Mean | Standard Error | score on a scale | Up to 36 weeks |
|
|
|
| Other Pre-specified | 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. | Intent to treat analysis | Posted | Mean | Standard Error | score on a scale | up to 36 weeks |
|
|
|
| Other Pre-specified | 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. | Longitudinal mixed effects model | Posted | Mean | Standard Error | score on a scale | up to 36 weeks |
|
|
|
| 0 |
| 36 |
| 1 |
| 36 |
| 0 |
| 36 |
| EG001 | 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 | 0 | 41 | 0 | 41 | 0 | 41 |
|
Not provided
Not provided
Not provided
| Mean Difference (Net) |
| -4.46 |
| Standard Error of the Mean |
| 2.05 |
| 2-Sided |
| 95 |
| -8.70 |
| -0.22 |
Difference between score at 8 weeks and score at baseline. |
| Other |
within group |
| Mean Difference (Net) |
| -1.72 |
| Standard Error of the Mean |
| 0.91 |
| 2-Sided |
| 95 |
| -3.60 |
| 0.16 |
Difference between score at 8 weeks and score at baseline. |
| Other |
within group change |
| Mean Difference (Net) |
| 0.35 |
| Standard Error of the Mean |
| 0.13 |
| 2-Sided |
| 95 |
| 0.07 |
| 0.63 |
Difference between score at 8 weeks and score at baseline. |
| Other |
within group change |
| 8 weeks |
|
| 22 weeks |
|
| 36 weeks |
|
| 8 weeks |
|
| 22 weeks |
|
| 36 weeks |
|