NCT04927286

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

June 14, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 29, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

June 3, 2021

Last Update Submit

September 22, 2022

Conditions

Keywords

adolescentsmindfulnessecological momentary assessment

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Mentoring+Mindfulness

EXPERIMENTAL
Behavioral: Learning to Breathe

Mentoring as usual

ACTIVE COMPARATOR
Behavioral: Campus Connections

Interventions

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

Mentoring+Mindfulness

Campus Connections is a mentoring program for at-risk adolescents

Mentoring as usual

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Colorado State Univeristy

Fort Collins, Colorado, 80526, United States

Location

Related Publications (2)

  • Miller-Chagnon RL, Shomaker LB, Prince MA, Krause JT, Rzonca A, Haddock SA, Zimmerman TS, Lavender JM, Sibinga E, Lucas-Thompson RG. The benefits of mindfulness training for momentary mindfulness and emotion regulation: A randomized controlled trial for adolescents exposed to chronic stressors. J Consult Clin Psychol. 2024 Dec;92(12):800-813. doi: 10.1037/ccp0000910.

  • Miller RL, Shomaker LB, Prince MA, Haddock S, Rzonca A, Krause JT, Zimmerman T, Lavender JM, Sibinga E, Lucas-Thompson RG. Momentary effects of life stressors on mindfulness and emotion regulation difficulties among adolescents exposed to chronic stressors. Stress Health. 2024 Oct;40(5):e3414. doi: 10.1002/smi.3414. Epub 2024 Apr 29.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 15, 2021

Study Start

June 14, 2021

Primary Completion

June 29, 2022

Study Completion

June 29, 2022

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations