CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 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/NCT04254796
NCT04254796N/ACompleted

Neural Mechanisms of Meditation Training in Healthy and Depressed Adolescents: An MRI Connectome Study

University of California, San Francisco·interventional·Posted Feb 5, 2020·Updated Jun 26, 2023

In Brief

A clinical study evaluating Training for Awareness, Resilience, and Action (TARA) for Healthy. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The primary objective will be to study changes in putamen structural connectivity in healthy teens with meditation training. Hypothesis: Putamen structural node strength will increase in the training group compared to controls. R61 Go/No-Go Criteria. Detect an effect size (a threshold of Cohen's d \> 0.20) in changes of the primary mechanistic outcome (Putamen structural node strength) by the described meditation training in 100 healthy adolescents that are 14-18 years old and retain at least 80% of randomized participants for primary outcome measurement at the end of the study regardless of adherence to the intervention. The secondary objective will be to study changes in emotional problems in healthy teens with meditation training. Hypothesis: There will be a significant decrease in emotional problems measured with the Strengths and Difficulties Questionnaire (SDQ) in the training group compared to controls. Design and Outcomes: The current research study design will utilize an individually randomized group treatment, open-label, waitlist-controlled clinical trial to test the efficacy and safety of the investigator's innovative mindfulness meditation intervention (Training for Awareness Resilience and Action \[TARA\]) on the primary outcome (Putamen structural node strength) and secondary outcome (emotional problems measured with the Strengths and Difficulties Questionnaire \[SDQ\]) in healthy adolescents between the ages of 14 to 18 years old.

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 5, 2020
Enrollment StartJun 19, 2020
Primary CompletionDec 20, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.4 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)