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Completed

NCT Number: NCT03270943

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

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).

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Key information

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Christine Lathren, MD, MPH

Chapel Hill, North Carolina, 27599-7200, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MFY

Behavioral

Mindful Self-Compassion course for teens

HLG

Behavioral

Healthy Lifestyles course for teens

Primary outcomes

  1. Time to Incident Depression

    Time frame: 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 outcomes

  1. Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores

    Time frame: 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

    Time frame: 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

    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). 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 outcomes

  1. Trajectory of SMFQ-C Depression Score Change

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Making Friends With Yourself: a Depression Prevention Program for Adolescents

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 1, 2017
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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