N/A
N=15
The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
Depression Mild · Resilience, Psychological · Adolescent Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03270943 ↗Enrolled (actual)
15
Serious AEs
1.3%
Results posted
May 2021
Primary outcome: Primary: Time to Incident Depression — 36; 18.86 weeks — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MFY (Behavioral); HLG (Behavioral)
- Age
- Pediatric · 14+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Incident Depression |
36; 18.86 | 0.02 sig |
| SECONDARY Change in Patient Reported Outcomes Measurement Information System (PROMIS) Pediatric Depression Scores |
52.7; 58.1; 51.6; 53.6 | — |
| SECONDARY Change in SMFQ Scores |
6.90; 9.67; 6.26; 7.95 | — |
| SECONDARY Change in Brief Resiliency Scale (BRS) Scores |
3.03; 3.05; 3.26; 3.40 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT03270943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.