Implementing Learning 2 BREATHE in Campus Connections

Mindfulness Clinical Trial

Official title:

Implementing Learning 2 BREATHE in Campus Connections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927286
• Other study ID #: 2008
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: June 29, 2022

Study information

• Verified date: September 2022
• Source: Colorado State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 29, 2022
• Est. primary completion date: June 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Mindfulness

Intervention

Behavioral:
• Learning to Breathe
Learning to Breathe is an evidence-based mindfulness curriculum for adolescents
• Campus Connections
Campus Connections is a mentoring program for at-risk adolescents

Locations

Country	Name	City	State
United States	Colorado State Univeristy	Fort Collins	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Colorado State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reward-based Eating Behaviors	Changes in Reward-based eating behaviors for all participants will be assessed with the Reward-based eating behaviors scale (Mason et al., 2017)	Through study completion, an average of 6 months
Primary	Internalizing and Externalizing Symptoms	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.	Through study completion, an average of 6 months
Primary	Mindfulness	The mindfulness attention and awareness scale (Brown & Ryan, 2003) will be used to assess for changes in mindfulness for all participants	Through study completion, an average of 6 months
Primary	Emotion Regulation	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	Through study completion, an average of 6 months