Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05619458 |
Other study ID # |
ULethbridge |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
November 21, 2022 |
Est. completion date |
February 28, 2023 |
Study information
Verified date |
November 2023 |
Source |
University of Lethbridge |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.