CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 21 enrolled
Drug / intervention
Training for Awareness, Resilience, and Action (TARA)behavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04548544
NCT04548544N/ACompleted

A Randomized Controlled Feasibility Study of Emotional Well-being of Adolescents Undergoing a Mindfulness Training During the COVID-19 Pandemic

University of California, San Francisco·interventional·Posted Sep 14, 2020·Updated Dec 11, 2024

In Brief

A clinical study evaluating Training for Awareness, Resilience, and Action (TARA) for Healthy. Completed, enrolled 21 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 14, 2020
Enrollment StartOct 18, 2019
Primary CompletionMay 20, 2020
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 5.8 years ago

Interventions

Training for Awareness, Resilience, and Action (TARA)behavioral

This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)