Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP)

Vanderbilt University

Status: Completed

Conditions: Mindfulness

Treatments: Behavioral: Youth Mindful Awareness Program (YMAP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04718129

570035

R33MH119270 (U.S. NIH Grant/Contract)

R61MH119270 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 110 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Mindfulness

Experimental group

Description:

Internet-based, coached Mindfulness Program. Nine weekly coached sessions with practice exercises between sessions.

Treatment:

Behavioral: Youth Mindful Awareness Program (YMAP)

Control

No Intervention group

Description:

Participants in this arm are randomly assigned to an assessment-only, no intervention control condition.