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Effectiveness of a Mindfulness Program on Emotion Regulation Among Youth Attending an Alternative School

Primary Purpose

Substance Use, Mindfulness, Adolescent Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mindfulness Intervention
Sponsored by
University of Lethbridge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

15 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Aged 15-19 years of age Enrolled in two specific courses offered at Victoria Park High School Exclusion Criteria: 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.

Sites / Locations

  • Victoria Park High SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness intervention

Arm Description

The intervention will consist of 6 one-hour sessions delivered once per week in a classroom at an alternative high school during normal school hours.

Outcomes

Primary Outcome Measures

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)
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).

Secondary Outcome Measures

Change from baseline in mindfulness on the 10-item Child and Adolescent Mindfulness Measure (CAMM).
The CAMM has good internal reliability in a variety of adolescent populations, with Cronbach's alpha scores reported between 0.80-0.84, and no significant gender differences. The measure uses a 5-point Likert scale with higher scores indicated greater mindfulness (Week 10 Score - Baseline Score).
Change from baseline in anxiety and depression symptoms on the 4-item Patient Health Questionnaire (PHQ-4).
The PHQ-4 is a reliable measure of anxiety (α = 0.82) and depression (α = 0.81) separately and in composite (α = 0.85). Items are measured on a 4-point Likert scale, with options ranging from "Not at all" to "Nearly every day", with higher scores indicating more frequent anxiety/depression symptoms (Week 10 Score - Baseline Score).
Change from baseline in self-esteem on the 5-item Brief Rosenberg Self-Esteem Scale.
The Brief Rosenberg Self-Esteem Scale assesses self-esteem by asking participants to reflect on the feelings they have about themselves using a 4-point scale ranging from strongly agree to strongly disagree, with higher scores indicating higher self-esteem (Week 10 Score - Baseline Score).
Change from baseline in school connectedness on an adapted version of the the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).
The version of the NLSAH-SCS that will be used in this study was developed by investigators of the COMPASS Study - a prospective cohort study that collects longitudinal data from a sample of grade 9-12 in Canada. The adapted measure predicts reduced health risk behaviour in Canadian high school students. Consistent with the original measure, response options range from 1=strongly disagree to 4=strongly agree, with higher scores indicating stronger feelings of school connectedness (Week 10 Score - Baseline Score).
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).
We have adapted the 5-item measure of school connectedness to measure an adolescent's sense of connectedness within their home (e.g., I feel close to people in my home, I feel safe in my home, I feel the adults in my home treat me fairly). Consistent with the original measure, response options range from 1=strongly disagree to 4=strongly agree, with higher scores indicating stronger feelings of connectedness at home (Week 10 Score - Baseline Score).
Change from baseline in substance use on the Screen for Substance-Related Risks and Problems in Adolescents (CRAFFT) 2.1+N
CRAFFT scores are strongly correlated with diagnostic classifications for substance use among adolescents. We will use the new 2.1+N version of the CRAFFT which also assess tobacco use and vaping. All questions have yes/no responses, with higher scores indicating more significant substance use and problems (Week 10 Score - Baseline Score).

Full Information

First Posted
November 8, 2022
Last Updated
December 1, 2022
Sponsor
University of Lethbridge
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1. Study Identification

Unique Protocol Identification Number
NCT05619458
Brief Title
Effectiveness of a Mindfulness Program on Emotion Regulation Among Youth Attending an Alternative School
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Lethbridge

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
BACKGROUND: The purpose of this study is to use a single-arm trial to assess the effectiveness of a 6-week mindfulness-based intervention (MBI) on the emotional, social, and behavioural well-being of adolescents attending an alternative school in Lethbridge, Alberta. Mindfulness focuses on cultivating present-moment awareness in a non-reactive and non-judgmental way. A 2017 meta-analysis found MBIs have a moderate effect on increasing mindfulness among youth in controlled studies. A 2020 meta-analysis found MBIs have an overall small effect size over a broad range of samples and mental health outcomes among youth. The review found that in clinical samples of youth the effect size for mental health outcomes is in the moderate range, and nearly three times the magnitude found of non-clinical samples. MBIs also improve the mental health of at-risk youth including those in foster care, prison, and those who are survivors of interpersonal trauma. The goal of the present study is to build upon emerging evidence suggesting MBIs may be a useful addition to the curriculum within an alternative school environment. Alternative schools, also called outreach schools in Alberta, address the interpersonal, social, and learning needs of teens that cannot be met in regular school settings. Alternative schools offer a flexible learning environment with innovative programming designed to provide academic, social and emotional supports and skill building. Youth who attend alternative schools experience more psychosocial problems, including adverse childhood experiences (ACEs), and health risk behaviours; and thus may benefits from MBIs. Learning how to regulate emotions in a socially adaptive and appropriate manner is an important part of healthy psychological development. Emotion regulation allows an adolescent greater autonomy, strengthens self-esteem and improves self-efficacy. The poor regulation of emotions is implicated in the diagnostic criteria of many mental health disorders. It is generally agreed in the literature that emotion regulation processes can be conscious or unconscious, and automatic or effortful. It is also generally agreed that emotion regulation involves both reducing the intensity and frequency of negative emotional states, as well as developing the ability to create and maintain positive emotions. While MBIs have been shown to strengthen emotion regulation in regular public high schools, the extent to which MBIs strengthen emotion regulation within alternative schools is not well understood, and the primary focus of the present study. The investigator will also explore the impact of an MBI intervention on mindfulness, psychological outcomes, social connection, and behaviour. INTERVENTION: In this study, the investigator will use the six-week, evidence-based Learning to BREATHE Program as the primary intervention. Learning to BREATHE teaches emotion regulation and stress-reduction in relatable ways for teens. The program is delivered flexibly and adaptively rather than as a manualized curriculum, which fits the learning environment and goals of alternative schools. To date, two studies have examined the effectiveness of the Learning to BREATHE program in alternative schools. The first study, based in the US, used a pre-post design and found significant improvements in self-esteem and perceived stress. The second study used a randomized controlled design with an active comparator to assess Learning to BREATHE against a program designed to reduce substance use. The team reported many intervention delivery problems within an alternative school, including youth who were disinterested and disruptive during sessions. Changes were made to the intervention throughout the trial to address these problems, including involving teachers and school support staff in the sessions as youth were more familiar and comfortable with them. They also shortened activities that youth found difficult (sitting meditation), and lengthening others that youth enjoyed (body scan meditations and restorative yoga exercises). At study end, the Learning to BREATHE program intervention was more effective at reducing depression than active control. However, the small sample size (N = 14 intervention, N = 13 active control) and changes to the intervention throughout the trial made it difficult to assess impacts. To address these problems before the present study began, the investigator worked with social workers, school administrators, and community stakeholders in 2018-2019 to adapt the Learning to BREATHE Program for delivery within an alternative school environment. Suggested adaptions for program delivery were pilot tested in 2019-20 in a small sample of junior high students (N = 17) in the Lethbridge Alternative School Program. Sessions were delivered by three facilitators with mindfulness training certification. Due to the COVID-19 pandemic intervention effectiveness could not be assessed. The investigator was limited to analyzing post-intervention data collected before government-mandated school closures in March 2020 (N = 6 of 17 students who took part in the program). Fidelity and observational data collected during each session was also analyzed, and used in a student MSc thesis. The findings suggest youth were engaged in the adapted version of the program, that their understanding of mindfulness as a tool for stress and coping increased, and that incorporating digital technology (apps) to deliver segments of the intervention promoted independent use of the digital tools by youth outside the sessions. METHODS: This intervention study will begin November 28, 2022, at a single location - Victoria Park High School in Lethbridge, AB. The study will be led by Dr. Cheryl Currie in the Faculty of Health Sciences at the University of Alberta in Alberta, Canada. The study is expected to end January 31, 2023. It is estimated that from time of first contact during student enrolment in the study each participant will be engaged in the study for nine weeks, excluding time away during the December holiday break. This includes one week to complete the pre-intervention data collection meeting with school staff, six weeks to take part in the intervention, and up to two weeks to complete a post-intervention data collection meeting with a school staff member. This study will recruit a school-based sample of approximately 35 youth that meet eligibility criteria to achieve 31 participants. Participants will be students registered in two specific classes in Victoria Park High School. These courses were chosen by school administration for participation in the program. A low (5%) loss to follow-up is expected given the program will be offered as part of two combined courses that students have chosen to enroll in. Students will complete the baseline survey immediately after completing the informed consent process by clicking the second Qualtrics tab that will be open on their iPad browser. The survey will be administered using the Qualtrics survey platform on iPads provided by the University of Lethbridge study team and will take approximately 20 minutes. Within two weeks of completing the intervention, participants will complete the same survey package they answered at baseline. ANALYSIS STRATEGY: Data will be analyzed using Stata 17.0 and R software. The investigator will use frequencies and percentages to summarize participant age, grade, genders, Indigenous status (identify as Indigenous - yes or no), immigrant status (born in Canada - yes or no), and who participants currently live with. The purpose of collecting this data is to create a broad, general description of the sample in dissemination documents. For prediction of emotion regulation pre- and post-intervention, participants will be included in the analysis if they have completed 50% of the intervention and completed follow-up data collection. Missing data for participants who meet these criteria will be addressed using multiple imputation. A repeated-measures, mixed-model approach will be used to identify significant changes in each of the primary and secondary outcomes pre-post intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use, Mindfulness, Adolescent Behavior, Emotion Regulation, Social Behavior, Self Esteem

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness intervention
Arm Type
Experimental
Arm Description
The intervention will consist of 6 one-hour sessions delivered once per week in a classroom at an alternative high school during normal school hours.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Intervention
Other Intervention Name(s)
Learning to Breathe Program
Intervention Description
6-week mindfulness intervention
Primary Outcome Measure Information:
Title
Change from baseline in emotion regulation on the 18-item Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Description
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)
Time Frame
Baseline and Week 10
Title
Change from baseline in emotion regulation on the 1-item Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA)
Description
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).
Time Frame
Baseline and Week 10
Secondary Outcome Measure Information:
Title
Change from baseline in mindfulness on the 10-item Child and Adolescent Mindfulness Measure (CAMM).
Description
The CAMM has good internal reliability in a variety of adolescent populations, with Cronbach's alpha scores reported between 0.80-0.84, and no significant gender differences. The measure uses a 5-point Likert scale with higher scores indicated greater mindfulness (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10
Title
Change from baseline in anxiety and depression symptoms on the 4-item Patient Health Questionnaire (PHQ-4).
Description
The PHQ-4 is a reliable measure of anxiety (α = 0.82) and depression (α = 0.81) separately and in composite (α = 0.85). Items are measured on a 4-point Likert scale, with options ranging from "Not at all" to "Nearly every day", with higher scores indicating more frequent anxiety/depression symptoms (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10
Title
Change from baseline in self-esteem on the 5-item Brief Rosenberg Self-Esteem Scale.
Description
The Brief Rosenberg Self-Esteem Scale assesses self-esteem by asking participants to reflect on the feelings they have about themselves using a 4-point scale ranging from strongly agree to strongly disagree, with higher scores indicating higher self-esteem (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10
Title
Change from baseline in school connectedness on an adapted version of the the National Longitudinal Study of Adolescent Health School Connectedness Scale (NLSAH-SCS).
Description
The version of the NLSAH-SCS that will be used in this study was developed by investigators of the COMPASS Study - a prospective cohort study that collects longitudinal data from a sample of grade 9-12 in Canada. The adapted measure predicts reduced health risk behaviour in Canadian high school students. Consistent with the original measure, response options range from 1=strongly disagree to 4=strongly agree, with higher scores indicating stronger feelings of school connectedness (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10
Title
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).
Description
We have adapted the 5-item measure of school connectedness to measure an adolescent's sense of connectedness within their home (e.g., I feel close to people in my home, I feel safe in my home, I feel the adults in my home treat me fairly). Consistent with the original measure, response options range from 1=strongly disagree to 4=strongly agree, with higher scores indicating stronger feelings of connectedness at home (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10
Title
Change from baseline in substance use on the Screen for Substance-Related Risks and Problems in Adolescents (CRAFFT) 2.1+N
Description
CRAFFT scores are strongly correlated with diagnostic classifications for substance use among adolescents. We will use the new 2.1+N version of the CRAFFT which also assess tobacco use and vaping. All questions have yes/no responses, with higher scores indicating more significant substance use and problems (Week 10 Score - Baseline Score).
Time Frame
Baseline and Week 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 15-19 years of age Enrolled in two specific courses offered at Victoria Park High School Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahala Swisterski, BHSc
Phone
403-332-4499
Email
mahala.morris@uleth.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Currie, PhD
Organizational Affiliation
University of Lethbridge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Victoria Park High School
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1J 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cayley King

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of a Mindfulness Program on Emotion Regulation Among Youth Attending an Alternative School

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