Clinical trial NCT03270943: 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
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Resilience, Psychological
Adolescent Behavior
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2017-09-01
Enrollment: 77
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Time to Incident Depression
timeFrame: weekly for up to 36 weeks
Secondary outcomes:
measure: Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores
timeFrame: Baseline, Week 8
measure: Change in SMFQ Scores
timeFrame: Baseline, Week 8
measure: Change in Brief Resiliency Scale (BRS) Scores
timeFrame: Baseline, Week 8
Other outcomes:
measure: Trajectory of SMFQ-C Depression Score Change
timeFrame: Up to 36 weeks
measure: Trajectory of PROMIS Depression Score Change
timeFrame: up to 36 weeks
measure: Trajectory of BRS Score Change
timeFrame: up to 36 weeks
Locations:
city: Chapel Hill
country: United States
facility: Christine Lathren, MD, MPH
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Susan Gaylord, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.