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

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ClinicalTrials.gov Identifier: NCT03270943
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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: TCY Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 4 cohorts of adolescents (n=80). This study is a planning grant for development of an adequately powered clinical trial. Randomization is designed to assess feasibility of our 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 : September 5, 2017
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Living

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 (TCY)
An 8-week healthy lifestyles course for teens. 6 monthly continuation sessions will occur following completion of the 8-week course.
Behavioral: TCY
Healthy Lifestyles course for teens




Primary Outcome Measures :
  1. Time (weeks) to incident depression [ Time Frame: Baseline until onset of incident depression, up to 36 weeks ]
    The Short Mood and Feelings Questionnaire (SMFQ) is a measure of the level of depressive symptoms. There is a 13-item youth version (SMFQ-C) and 13-item parent version (SMFQ-P). 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). A score of 8 on the SMFQ-C (child survey) or a combined score of 12 on the SMFQ-C and SMFQ-P (parent survey) constitutes incident depression. Lower scores over time indicate improvement in incident depression.


Secondary Outcome Measures :
  1. Change in SMFQ Scores at Week 8 [ Time Frame: Baseline, Week 8 ]
    The Short Mood and Feelings Questionnaire (SMFQ) is a measure of the level of depressive symptoms. There is a 13-item youth version (SMFQ-C) and 13-item parent version (SMFQ-P). 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). Lower scores at each time point indicate improvement.

  2. Trajectory of SMFQ Depression Score Change [ Time Frame: Baseline (Week 0) through completion, average 36 weeks ]
    The Short Mood and Feelings Questionnaire (SMFQ) is a measure of the level of depressive symptoms. There is a 13-item youth version (SMFQ-C) and 13-item parent version (SMFQ-P). 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). Lower scores at each time point indicate improvement.

  3. Change in Brief Resiliency Scale (BRS) Scores at Week 8 [ Time Frame: 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) giving a possible scoring range from 6-30. Scores are summed and totals divided by the number of questions answered. Higher scores at each time point indicate increasing resilience.

  4. Trajectory of BRS Score Change [ Time Frame: Baseline (Week 0) through completion, average 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) giving a possible scoring range from 6-30. Scores are summed and totals divided by the number of questions answered. Higher scores at each time point indicate increasing resilience.



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03270943


Contacts
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Contact: Chanee Lynch, MPH 919-966-8586 smartstudy@med.unc.edu
Contact: Susan Gaylord, PhD 919-966-8586 gaylords@med.unc.edu

Locations
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United States, North Carolina
UNC Program on Integrative Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599-7200
Contact: Chanee Lynch, MPH    919-966-8586    smartstudy@med.unc.edu   
Principal Investigator: Susan Gaylord, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Susan Gaylord, PhD University of North Carolina, Chapel Hill

Publications:
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03270943     History of Changes
Other Study ID Numbers: 16-1864
R34AT008822-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders