Testing the Effect of the Youth Mindful Awareness Program on Negative Affect

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Targeting Negative Affect Through Mindfulness Training in Youth at Risk for Internalizing Problems - R61

Conditions
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Mindfulness

Intervention / Treatment
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* Behavioral: Youth Mindful Awareness Program (YMAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ages 12- to 17-years-old has access to a smartphone, tablet, or other mobile device on which they can access the mindfulness app and complete EMA reports. Youth without a device will be provided with one for their time in the study. Exclusion Criteria: current DSM5 diagnosis of an anxiety or depressive disorder with significant clinical impairment current alcohol or substance use disorder; currently suicidal lifetime diagnosis of bipolar disorder, schizophrenia, autism, conduct disorder, or developmental delay reading level below 4th grade not English speaking at a level that would allow them to participate in the intervention and assessments.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Mindfulness vs. No intervention control
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions. | Behavioral: Youth Mindful Awareness Program (YMAP)<br>* The Mindfulness Intervention is an internet-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.<br>|
| No Intervention: Control<br>Participants in this arm are randomly assigned to an assessment-only, no intervention control condition. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative Affect assessed with Ecological Momentary Assessment | The measure of momentary negative affect includes 7 items rated on a 4-point scale; average scores can range from 1.00 to 4.00. Higher scores indicate more negative affect. | Through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness