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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TARA training | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Training for Awareness, Resilience, and Action (TARA) | Behavioral | This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in SDQ Emotional Problems | 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. | Baseline/randomization and 12 weeks after baseline/randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olga Tymofiyeva, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | TARA Training | Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
| FG001 | Control | passive control |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | TARA Training | Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in SDQ Emotional Problems | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline/randomization and 12 weeks after baseline/randomization |
|
12 weeks
Solicited adverse events in TARA participants were captured as follows: before each TARA session participants were asked through a questionnaire: "Has there been any significant unfavorable change in your mental or physical health since last class?"; if the participant answers "yes" to this question, then the research assistant or another study staff member asked the participant for additional details regarding the participant's answer and this information was recorded in the Adverse Event form.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TARA Training | Training for Awareness, Resilience, and Action (TARA): This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olga Tymofiyeva | University of California, San Francisco | 415-514-4870 | Olga.Tymofiyeva@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2020 | Nov 27, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Nov 27, 2023 | ICF_001.pdf |
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passive control
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | male, female, other | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| SDQ emotional symptoms | The Strengths and Difficulties Questionnaire (SDQ) measures emotional and behavioral problems. Total raw scores range from 0-50. We transformed these raw SDQ scores into t-scores, a standardized score that indicates how many standard deviations a particular data point is away from the mean, which range from 0-100. Higher scores indicate more problems. | Mean | Standard Deviation | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control | passive control | 0 | 9 | 0 | 9 | 0 | 9 |
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