Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R61MH119270 | U.S. NIH Grant/Contract | View source | |
| R33MH119270 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Northwestern University | OTHER |
| University of California, Los Angeles | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Randomized controlled trial comparing a coached, app-based mindfulness intervention versus a no-intervention control condition. Primary outcome: adolescents' reports of affect as measured with ecological momentary assessment (EMA) at post-intervention. Participants will include 120 youth ages 12-17 years old.
This is a randomized controlled trial testing a 9-session, coached, app-based mindfulness intervention on adolescents' reports of affect as measured with ecological momentary assessment (EMA). Participants will include 120 youth ages 12- to 17-years-old randomized to either the Youth Mindful Awareness Program (YMAP) or to an assessment only control condition. Participation is open to all genders and youth of all races and ethnicities.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. |
|
| Control | No Intervention | Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Youth Mindful Awareness Program (YMAP) | Behavioral | The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Momentary Negative Affect Assessed With Ecological Momentary Assessment | Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA). | 5 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Judy Garber, PhD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Judy Garber | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39621373 | Derived | Garber J, Chavira DA, Adam EK, Craske MG, McMahon T, Williams A, Abitante G, Lanser I, Pashtunyar DS, Chen S, Zinbarg R. A randomized controlled trial of an online mindfulness program for adolescents at risk for internalizing problems. J Consult Clin Psychol. 2025 Apr;93(4):226-237. doi: 10.1037/ccp0000921. Epub 2024 Dec 2. |
Not provided
Not provided
Results will be shared through Clinical Trials.gov, and by the study PIs at scientific conferences and publications in scientific journals. IPD will be available upon request.
Data will be available after study completion and publications of study results.
Access to study data will require a written request to the PIs. The request should include a description of the research question(s), planned analyses, and data requested.
Not provided
After parents completed the consent form and the teen completed the assent form, the teen was interviewed regarding the inclusion and exclusion criteria (e.g., psychiatric symptoms and diagnoses).
Participants were recruited through a university listserv, advertising on FaceBook and in subways (in Chicago), local schools, and community events. Recruitment began 05/15/2021
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness | Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. Youth Mindful Awareness Program (YMAP): The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions. |
| FG001 | Control | Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All 110 randomized participants were included in the "intent to treat" analyses regardless of attrition.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness | Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. Youth Mindful Awareness Program (YMAP): The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions. |
| BG001 |
| 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 | Momentary Negative Affect Assessed With Ecological Momentary Assessment | Momentary negative affect (mNA) in EMA is the experience of negative emotional states in the moment. Participants complete the Ecological Momentary Assessment (EMA) 4 times a day for 5 days, at random moments across the day (usually once in the morning, once in the early afternoon, once in the late afternoon and once in the evening). The EMA affect measure includes 7 items rated on a 4-point scale; average scores range from 1.00 to 4.00; higher scores indicate more negative affect (NA). | All 110 randomized participants | Posted | Mean | Standard Deviation | score on a scale | 5 days |
|
Two years
The definition of adverse event and serious adverse event used to collect adverse event information was from the clinicaltrials.gov Definitions.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness | Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. Youth Mindful Awareness Program (YMAP): The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Vanderbilt University | 615-330-5605 | jgarber.vanderbilt@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 18, 2024 | Jul 19, 2024 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Mar 31, 2025 | SAP_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF parent part 2 | Jan 27, 2023 | Oct 31, 2023 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: ICF parent part 1 | Jan 27, 2023 | Oct 31, 2023 | ICF_001.pdf |
Not provided
Mindfulness vs. No intervention control
Not provided
Not provided
Assessors of outcomes will be masked to intervention condition
| Control |
Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Control | Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. |
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Control | Participants in this arm were randomly assigned to an assessment-only, no intervention control condition. | 0 | 57 | 0 | 57 | 0 | 57 |
Not provided
Not provided