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NCT03270943 · ClinicalTrials.gov registry record · NA
The S.M.A.R.T. Project: Stress Management and Resilience Training for Teens
A NA study of Adolescent Behavior and Depression Mild, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 77
- Enrollment target
- 1
- Study location
NCT03270943: Completed NA study of Adolescent Behavior and Depression Mild, sponsored by University of North Carolina, Chapel Hill.
NCT03270943 is a NA study of Adolescent Behavior and Depression Mild that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 77 participants, below the 328-participant average among 46 other Adolescent Behavior trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03270943, a NA study of Adolescent Behavior and Depression Mild, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 77 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
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. High
Conditions Studied
Interventions
- BEHAVIORAL MFY
- BEHAVIORAL HLG
Study Locations (1)
North Carolina
- Christine Lathren, MD, MPH - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2017-09-05 |
| Est. Completion | 2020-06-03 |
| Phase | NA |
What the finished NCT03270943 record still lists
NCT03270943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 328-participant average among 46 other Adolescent Behavior trials with a reported enrollment target (77% lower).
The record links to 3 conditions, with Adolescent Behavior appearing as the primary indexed condition, and to 2 interventions - of which MFY is the first listed.
NCT03270943 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03270943 about?
NCT03270943 is a clinical study titled "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...
What is the current status of trial NCT03270943?
This trial is currently completed. It is a NA study. The enrollment target is 77 participants. The study started on 2017-09-05. Estimated completion is 2020-06-03.
What conditions does trial NCT03270943 study?
This clinical trial studies the following conditions: Adolescent Behavior, Depression Mild, Resilience, Psychological.
What interventions are being tested in trial NCT03270943?
The interventions under investigation include: MFY (BEHAVIORAL), HLG (BEHAVIORAL).
Who is sponsoring clinical trial NCT03270943?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03270943 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03270943's enrollment target sits among peer trials
77 38th of 46 higher than 9 of 46 other Adolescent Behavior trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Adolescent Behavior trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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