Implementing Learning 2 BREATHE in Campus Connections

September 22, 2022 updated by: Colorado State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Fort Collins, Colorado, United States, 80526
        • Colorado State Univeristy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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
Through study completion, an average of 6 months
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
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Actual)

June 29, 2022

Study Completion (Actual)

June 29, 2022

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Actual)

September 26, 2022

Last Update Submitted That Met QC Criteria

September 22, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008 (U.S. NIH Grant/Contract: Ministry of Health)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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