Mental Health Intervention Research in At-Risk Adolescents

NCT05760443 | Completed

• 1 other identifier: 4219
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the proposed research is to support adolescent health through providing inclusive evidence-based programming that is in line with community needs. Specifically, the investigators aim to: 1) investigate the effects of mindfulness-based intervention (MBI) on adolescent mental health, 2) identify underlying mechanisms (e.g., engagement, stress physiology, emotion regulation) of MBI for adolescent health and wellbeing 3) identify facilitators and barriers of engagement in MBI for community adolescents.

Conditions

Mental Health Wellness 1

Outcome Measures

Primary Outcomes (11)

• Emotion Regulation - Adolescent Report

  Adolescent self-report on Difficulties in Emotion Regulation Scale - Short Form; The scale yields a sum score from 0-90 on 18 items. Higher scores indicate more difficulties in emotion regulation

  6 weeks

• Emotion Regulation - Parent Report

  Parent self-report on Difficulties in Emotion Regulation Scale - Parent Version; The scale yields a sum score from 0-145 on 29 items. Higher scores indicate more difficulties in emotion regulation

  6 weeks

• Mindfulness - Attention

  Adolescent self report on the Mindful Attention Awareness Scale; The scale yields a sum score from 0-75 on 15 items, and then an average will be taken. Higher scores reflect higher levels of dispositional mindfulness.

  6 weeks

• Mindfulness - Self Compassion

  Adolescent self report on the Self Compassion Scale - Short Form; The scale yields a sum score from 0-60 on 12 items, and then an average will be taken. Higher scores reflect higher levels of self compassion.

  6 weeks

• Mindfulness - Behavioral Task

  Adolescent will complete the Breath Counting Task, a 20-minute computer-administered objective measure of mindfulness. In the task, participants are required to count their breaths in cycles of nine, indicating each breath with a button press. Counting accuracy is calculated as 100% - (# of incorrect ongoing 9-counts + # of self-caught miscounts)/(# of ongoing 9-counts + # of self-caught miscounts).

  6 weeks

• Stress Reactivity - Respiratory Sinus Arrythmia

  Respiratory changes will be measured measured by recording the rate and depth of the breathing cycle using a pneumograph transducer fastened around the center of the chest; this transducer measures changes in chest expansion and contraction. This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.

  6 weeks

• Stress Reactivity - Skin Conductance

  Skin conductance level will be measured by attaching two electrodes to the participant's fingertips (on the index and middle finger of the left hand). This data will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.

  6 weeks

• Stress Reactivity - Heart Rate

  Electrocardiogram (ECG) will be used to record the electrical signal of the heart using electrodes on both legs above the ankle both and above the right wrist. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.

  6 weeks

• Stress Reactivity - Blood Pressure

  A Dinamap Pro will be used to measure systolic and diastolic blood pressure. This will be collected throughout a brief baseline period, a stressor task (the Trier Social Stress Task), and a recovery period.

  6 weeks

• Mental health - Anxiety

  Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Anxiety. The scale produces a sum score of 13 to 65 with higher scores indicating greater severity of anxiety.

  6 weeks

• Mental health - Depression

  Self report on Patient Reported Outcome Measurement Information System Emotional Distress Scale - Depression. The scale produces a sum score of 14 to 70 with higher scores indicating greater severity of depression.

  6 weeks

Secondary Outcomes (12)

• Compassion for others

  6 weeks

• Stress appraisal

  6 weeks

• Social Media Use

  6 weeks

• Eating behavior

  6 weeks

• Objectified Body Consciousness

  6 weeks

Study Arms (1)

Mindfulness-based intervention

EXPERIMENTAL

6 week group mindfulness-based intervention

Behavioral: Learning to BREATHE

Interventions

Learning to BREATHE BEHAVIORAL

Learning 2 BREATHE (L2B) is an empirically-supported, manualized mindfulness-based group program (Broderick, 2021). Participants attend 6 sessions of approximately 1.5 hours per session. "BREATHE" is an acronym: Body, Reflections, Emotions, Attention, Tenderness, Habits, Empowerment; each week's lesson is centered around one of the letters (week 1 encompasses both Body and the overall theme of the sessions, Empowerment). Sample activities of L2B include psycho-education on emotion and self-regulation, body scanning, sitting meditation, non-aerobic yoga, and walking meditation, designed to promote moment-to-moment awareness of mind-body experiences. In between sessions, participants are encouraged to practice brief mindfulness skills in their daily lives and to complete the "homework" assignments, such as an audio-guided body scan. Participants will have access to home-practice audio-recordings and will be queried about their completion of home-practice assignments.

Mindfulness-based intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \) between the ages of 12-18 years old,
• \- 2) Reside in Larimer County or the surrounding area.

You may not qualify if:

• Adolescents will not take part in the program if they demonstrate active suicidal ideation and/or behavior.
• Adolescents will not take part in the program and/or research activities if they have a medical and/or psychological/behavioral condition that, in the opinion of the research team, could interfere with safety for themselves or others or interfere with the capability of the youth or other participants to potentially benefit from the program (e.g., severe emotional-behavioral disturbance, inability to follow facilitator directions) .

Sponsors & Collaborators

• Colorado State University: lead

Study Sites (1)

Colorado State University

Fort Collins, Colorado, 80523, United States

Location

Study Officials

• Lauren Shomaker, Ph.D.

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2023
• First Posted: March 8, 2023
• Study Start: May 15, 2023
• Primary Completion: October 1, 2024
• Study Completion: May 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)