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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2023-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).

NCT06526052

Prevention Control

RECRUITING NA

Tailored Mindfulness Intervention in Adolescence

NCT03404349

Stress Mindfulness Affect

COMPLETED NA

Trauma-Informed Mindfulness-Based Yoga

NCT03581461

Trauma

COMPLETED NA

Kind Minds Program for Youth With Anxiety and Depression

NCT05353751

Child Anxiety Depression

RECRUITING NA

Remote Mindfulness Training Following Early Life Adversity

NCT05516108

Stress Mindfulness Early Life Adversity

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mindfulness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mindfulness vs. No intervention control

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Assessors of outcomes will be masked to intervention condition

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mindfulness

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

Group Type EXPERIMENTAL

Youth Mindful Awareness Program (YMAP)

Intervention Type 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.

Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes