search
Back to results

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

Primary Purpose

Depression Mild, Resilience, Psychological, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MFY
HLG
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression Mild

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Christine Lathren, MD, MPH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful Self-Compassion (MFY)

Healthy Lifestyles (HLG)

Arm Description

An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.

An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
August 25, 2017
Last Updated
April 26, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT03270943
Brief Title
The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
Official Title
Making Friends With Yourself: a Depression Prevention Program for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
June 3, 2020 (Actual)
Study Completion Date
June 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Resilience, Psychological, Adolescent Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
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.
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Self-Compassion (MFY)
Arm Type
Experimental
Arm Description
An 8-week mindfulness self-compassion course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
Arm Title
Healthy Lifestyles (HLG)
Arm Type
Active Comparator
Arm Description
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
Intervention Type
Behavioral
Intervention Name(s)
MFY
Intervention Description
Mindful Self-Compassion course for teens
Intervention Type
Behavioral
Intervention Name(s)
HLG
Intervention Description
Healthy Lifestyles course for teens
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
Other Pre-specified Outcome Measures:
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Gaylord, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christine Lathren, MD, MPH
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7200
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26005198
Citation
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.
Results Reference
background
PubMed Identifier
27110301
Citation
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.
Results Reference
background
PubMed Identifier
26997856
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs