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

Adolescent Behavior Clinical Trial

Official title:

Making Friends With Yourself: a Depression Prevention Program for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03270943
• Other study ID #: 16-1864
• Secondary ID: R34AT008822-01A1
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: June 3, 2020

Study information

• Verified date: March 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: June 3, 2020
• Est. primary completion date: June 3, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Behavior
• Depression
• Depression Mild
• Resilience, Psychological

Intervention

Behavioral:
• MFY
Mindful Self-Compassion course for teens
• HLG
Healthy Lifestyles course for teens

Locations

Country	Name	City	State
United States	Christine Lathren, MD, MPH	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2015 Dec 19. — View 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. Epub 2015 Oct 23. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	Up to 36 weeks
Other	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
Other	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
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.	weekly for up to 36 weeks
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.	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).	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.	Baseline, Week 8