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OpenTrials
Completed

NCT Number: NCT04927286

Implementing Learning 2 BREATHE in Campus Connections

The overall objective of this study is to investigate a mindfulness-based intervention's feasibility/acceptability and effectiveness for improving eating behaviors and depression symptoms among adolescents (9-18y; 63% living on low-income), referred to a community-based mentoring program for being "at-risk for not reaching their full potential" (e.g., Department of Human Services involvement, behavioral/emotion problems). As a part of this study, we will also characterize the real-time relationships among life stressors, untrained state mindfulness, and emotion regulation difficulties in adolescents' daily lives and determine to what extent an MBI helps adolescents to maintain mindfulness and emotion regulation in moments when they experience a stressor.

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Key information

Conditions

Mindfulness

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Colorado State Univeristy

Fort Collins, Colorado, 80526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mentees (adolescents) participating in campus connections who are 9-18y and English speaking

Exclusion criteria

  • Mentees (adolescents) that are not participating in campus connections

Treatment and study plan

Learning to BREATHE

Behavioral

Learning to Breathe is an evidence-based mindfulness curriculum for adolescents

Campus Connections

Behavioral

Campus Connections is a mentoring program for at-risk adolescents

Primary outcomes

  1. Reward-based Eating Behaviors

    Time frame: Through study completion, an average of 6 months

    Changes in Reward-based eating behaviors for all participants will be assessed with the Reward-based eating behaviors scale (Mason et al., 2017)

  2. Internalizing and Externalizing Symptoms

    Time frame: Through study completion, an average of 6 months

    The Brief problem monitor (Achenbach et al., 2011) will be used to assess for changes in internalizing (e.g., depression symptoms) and externalizing symptoms for all participants.

  3. Mindfulness

    Time frame: Through study completion, an average of 6 months

    The mindfulness attention and awareness scale (Brown & Ryan, 2003) will be used to assess for changes in mindfulness for all participants

  4. Emotion Regulation

    Time frame: Through study completion, an average of 6 months

    The Difficulties in Emotion Regulation Scale-Short Form (Kaufman et al., 2016) will be used to assess for changes in difficulties with emotion regulation for all participants

Sponsors and collaborators

Lead sponsor

Colorado State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 15, 2021
Registry last updated
Sep 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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