Implementing Learning 2 BREATHE in Campus Connections

Sponsor

Colorado State University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04927286

Collaborator

(none)

103

Enrollment

Location

Arms

13.6

Anticipated Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Mindfulness	Behavioral: Learning to Breathe Behavioral: Campus Connections	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Implementing Learning 2 BREATHE in Campus Connections

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mentoring+Mindfulness	Behavioral: Learning to Breathe Learning to Breathe is an evidence-based mindfulness curriculum for adolescents
Active Comparator: Mentoring as usual	Behavioral: Campus Connections Campus Connections is a mentoring program for at-risk adolescents

Arm

Intervention/Treatment

Experimental: Mentoring+Mindfulness

Behavioral: Learning to Breathe

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

Active Comparator: Mentoring as usual

Behavioral: Campus Connections

Campus Connections is a mentoring program for at-risk adolescents

Outcome Measures

Primary Outcome Measures

Reward-based Eating Behaviors [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)
Internalizing and Externalizing Symptoms [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.
Mindfulness [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
Emotion Regulation [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Colorado State Univeristy	Fort Collins	Colorado	United States	80526

Sponsors and Collaborators

Colorado State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Colorado State University

ClinicalTrials.gov Identifier:

NCT04927286

Other Study ID Numbers:

2008

First Posted:

Jun 15, 2021

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Colorado State University

adolescents

mindfulness

ecological momentary assessment

Study Results

No Results Posted as of Jul 22, 2022