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NCT04548544 · ClinicalTrials.gov registry record · NA
A Study of Adolescents Undergoing a Mindfulness Training During COVID-19
A NA study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT04548544: Completed NA study, sponsored by University of California, San Francisco.
NCT04548544 is a NA study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04548544, a NA study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
The COVID-19 pandemic has been significantly affecting people's lives around the globe. Social distancing, self-quarantine, shelter-in-place measures, economic challenges, and COVID-19-cased illness and deaths have the potential to significantly impact mental health and cause stress, anxiety, and depression. Adolescents may be especially vulnerable to this situation, due to their increased vulnerability to the onset of depression and anxiety in general. One promising approach to reduce anxiety and depression in youth is a neuroscience-based mindfulness intervention Training for Awareness Resilience and Action (TARA). TARA is usually delivered over 12 weeks by two facilitators in groups of 10-15 adolescents in-person, and it has been shown to reduce symptoms of depression and anxiety in depressed adolescents and modify brain properties. The TARA intervention can also be delivered remotely. Other types of therapy delivered remotely, such as internet-based cognitive behavioral therapy, have shown comparable efficiency to face-to-face delivery. The objective of this study is to utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the feasibility of TARA (delivered partially over Zoom) in improving the self-reported emotional well-being primary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old during the COVID-19 pandemic. Our central hypothesis is that emotional well-being of adolescents in the intervention group will improve stronger (or deteriorate less) than in the control group. We will test this hypothesis in 21 adolescents randomized to the TARA intervention (partially delivered over Zoom) (12 adolescents) or to the waitlist control group (9 adolescents).
Primary Outcome
Change in the level of emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ). The emotional problems scores have a possible range of 0 to 100. Higher scores represent higher levels of emotional problems.
Interventions
- BEHAVIORAL Training for Awareness, Resilience, and Action (TARA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2019-10-18 |
| Est. Completion | 2020-05-20 |
| Phase | NA |
What the finished NCT04548544 record still lists
NCT04548544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Training for Awareness, Resilience, and Action (TARA) is the first listed.
NCT04548544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04548544 about?
NCT04548544 is a clinical study titled "A Study of Adolescents Undergoing a Mindfulness Training During COVID-19". The COVID-19 pandemic has been significantly affecting people's lives around the globe. Social distancing, self-quarantine, shelter-in-place measures, economic challenges, and COVID-19-cased illness and deaths have the potential to significantly impact mental health and cause stress, anxiety, and de...
What is the current status of trial NCT04548544?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2019-10-18. Estimated completion is 2020-05-20.
What interventions are being tested in trial NCT04548544?
The interventions under investigation include: Training for Awareness, Resilience, and Action (TARA) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04548544?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04548544's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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