Effectiveness of a Mindfulness Program on Emotion Regulation Among Youth Attending an Alternative School
Condition: Substance Use; Mindfulness; Adolescent Behavior; Emotion Regulation; Social Behavior; Self Esteem
MeSH terms: Substance-Related Disorders
Study type: Interventional

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.
    

Intervention name(s): Mindfulness Intervention
Intervention type(s): Behavioral
Intervention description(s): 6-week mindfulness intervention
Other intervention name(s): Learning to Breathe Program
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention