Effectiveness of a Mindfulness Program on Emotion Regulation Among Youth Attending an Alternative School
Effectiveness of an Adapted Version of the Learning to BREATHE Program on Emotion Regulation Among Youth Attending an Alternative High School: Rationale and Design for a Single-arm Trial
1 other identifier
interventional
25
1 country
1
Brief Summary
The main goal of this single-arm pre-post intervention study is to see if an adapted mindfulness program can improve emotion regulation among youth aged 15-19 years who attend an alternative school. Participants will complete a baseline survey package using an iPad. They will then receive an adapted version of the 6-session Learning to BREATHE Program as part of a course they are taking at their school. Students will again complete a survey package within 2 weeks of completing the program. The investigator will compare baseline and post-intervention survey responses to see if the program improved emotion regulation, as well as several secondary psychosocial and behavioral outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2022
CompletedFirst Posted
Study publicly available on registry
November 16, 2022
CompletedStudy Start
First participant enrolled
November 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedDecember 1, 2023
November 1, 2023
3 months
November 8, 2022
November 29, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Change from baseline in emotion regulation on the 18-item Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
The DERS-SF has excellent psychometric properties regardless of age and gender variation. A 5-point Likert scale from 1 (almost never) to 5 (almost always) is employed, with higher scores indicating greater emotion regulation impairment or dysregulation (Week 10 Score - Baseline Score)
Baseline and Week 10
Change from baseline in emotion regulation on the 1-item Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
The ERQ-CA assesses use of two emotion regulation strategies: cognitive reappraisal where a person attempts to change how they think about a situation to change its emotional impact, and expressive suppression where a person attempts to inhibit the behavioural expression of their emotions. A 5-point Likert scale from 1 (almost never) to 5 (almost always) is employed, with higher scores indicating greater emotion regulation impairment or dysregulation (Week 10 Score - Baseline Score).
Baseline and Week 10
Secondary Outcomes (6)
Change from baseline in mindfulness on the 10-item Child and Adolescent Mindfulness Measure (CAMM).
Baseline and Week 10
Change from baseline in anxiety and depression symptoms on the 4-item Patient Health Questionnaire (PHQ-4).
Baseline and Week 10
Change from baseline in self-esteem on the 5-item Brief Rosenberg Self-Esteem Scale.
Baseline and Week 10
Change from baseline in school connectedness on an adapted version of the the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).
Baseline and Week 10
Change from baseline in home connectedness on an adapted 5-item version of the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).
Baseline and Week 10
- +1 more secondary outcomes
Study Arms (1)
Mindfulness intervention
EXPERIMENTALThe intervention will consist of 6 one-hour sessions delivered once per week in a classroom at an alternative high school during normal school hours.
Interventions
6-week mindfulness intervention
Eligibility Criteria
You may qualify if:
- Aged 15-19 years of age
- Enrolled in two specific courses offered at Victoria Park High School
You may not qualify if:
- Unwilling to give consent
- Lack capacity to provide informed consent as determined by the educational assistant who will complete the informed consent process with each potential participant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Victoria Park High School
Lethbridge, Alberta, T1J 2M4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryl Currie, PhD
University of Lethbridge
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 8, 2022
First Posted
November 16, 2022
Study Start
November 21, 2022
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
December 1, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share