A Feasibility (pilot) Mixed Methods Study of an Innovative Non-Pharmacological Breath-Based Yoga and Social Emotional Intervention Program in an At-Risk Youth Sample in London, Canada

doi:10.21203/rs.3.rs-2037667/v1

Background: Various service provision models for youth at risk of homelessness have been researched and implemented, including access to housing, physical and mental health resources, etc. However, even with these interventions we remain unaware regarding how best to manage symptoms of depression and anxiety and the rate of drug use in these populations primarily because of lack of feasibility data.

Methods: This paper presents the results of a mixed-methods study in London, Canada, that examined the feasibility of implementing a biopsychosocial intervention, SKY Schools, in at-risk youth aged between 16-25 (n=49). The study also recorded qualitative responses about the program’s usefulness from the perspective of the service users. The SKY Schools intervention consisted of social-emotional learning combined with Sudarshan Kriya Yoga, a standardized yoga-based breathing exercise routine. The intervention program was divided into two phases; an active learning phase and a reinforcement phase.

Results: The results demonstrated that it is feasible to conduct a definitive trial in this population due to a high retention rate (61.2%) and overall positive feedback.

Conclusions: Future researchers may consider the feedback received when designing a randomized control trial to further assess efficacy and tolerability.

Trial Registration: Trial registration: Clinicaltrials.gov, Identifier NCT02749240. Registered April 22, 2016, https://clinicaltrials.gov/ct2/show/NCT02749240

Youth at-risk

homeless

mental health

depression

yoga

It is extremely difficult to conduct clinical intervention trials in youth at risk of homelessness, though they are at the highest risk of depression, anxiety and substance use. Hence, it is important to collect quantitative and qualitative data from this sample to inform future studies.

2) What are the key feasibility findings?

Using a biopsychosocial intervention designed specifically for youth at risk of homelessness, we were able to retain 61% of study sample. Mixed messaging was obtained regarding the benefit of the intervention and the logistics of trial delivery.

3) What are the implications of the feasibility findings for the design of the main study?

Our findings suggest that there is a need for improved content as well as delivery of the intervention, specifically excluding those who are already homeless as they are unable to receive the intervention consistency, and, a need to provide better child care facilities. Inclusion of an active control arm in the study design would likely lead to better recruitment and retention.

Youth at risk of homelessness are best defined as those who are highly susceptible to becoming homeless due to economic, personal or familial situations (Begin et al., 1999). They are likely one of the most vulnerable members of society. In a sample of such youth from downtown Toronto, Canada, it was found that majority had left home and school prematurely, been arrested in their lifetime, and used at least one illicit drug in the past 12 months. A substantial had been imprisoned, experienced physical abuse, and exhibited depressive symptomatology and suicidal ideation (Cameron et al., 2004). Similar results were found in another metropolitan city, Vancouver, Canada (Goldman-Hasbun et al., 2019) with high rates of incarceration as well as stimulant and opioid use.

Various service provision models have been considered for this population, yet there is a lack of a gold-standard model, likely due to difficulty in conducting clinical trials in this population. Expert opinion based on small trial data suggests supported housing, transitional case management and collaborative care models are useful. A Delphi survey of experts in the field of at-risk population suggested need for prioritization of provision of mental health and addiction care, facilitating access to permanent housing and income support, and case management/care coordination. The survey participants also ranked specific homeless sub-populations in need of additional research including: Indigenous Peoples (First Nations, Métis, and Inuit); youth, women and families; people with acquired brain injury, intellectual or physical disabilities; and refugees and other migrants (Shoemaker et al., 2020).

Within the field of mental health care delivery, recent trend data about the services for youth in the Canadian population suggests a strong increase in past-year mental health consultations from 2011 to 2018, a rise in the prevalence of diagnosed mood and anxiety disorders as well as slight increase in illicit drug use (Wiens et al., 2020). In the Canadian province of Ontario, the rates of mental health emergency department visits among youth increased from 11.7 per 1000 in 2003 to 24.1 per 1000 in 2017 (Gardner et al., 2019). The data above suggests that traditional hospital-based youth mental health services are currently stretched in Ontario. While data is not available, it could be that further marginalized youth such as those at risk of homelessness, who are the most in need of services, are unable to access traditional psychiatric services due to various reasons including stigma and system pressures.

Being aware of these pressures, our team has previously attempted to design an integrative and collaborative youth mental health service model in a medium sized Canadian city (London, Ontario). We have previously partnered with the Youth Opportunities Unlimited (YOU), which started as a downtown transition home established in 1982 with dedicated funding from various federal and provincial support organizations. Approximately 3,600 youth between the ages of 16-30 access the system of supports available at YOU each year. Services have expanded over the years and include provision of basic needs and housing, access to physical, mental and dental health care, education and employment supports, and social learning opportunities designed to help youth lead positive lives (Unlimited, 2020). The agency has numerous service programs including a drop-in center with meals, counselling, social enterprises for employment, educational supports and transitional services for youth exiting child protection services. Recently they have also opened a youth emergency shelter. At-risk youth who have used YOU have found them useful based on internal audit data. However, the rates of drug use, depression and anxiety symptoms remain high even after provision of services, most likely due to the nature of the multiple challenges faced by the population.

The authors hypothesized that an augmentation strategy of current services offered by YOU would lead to an improvement in service user experiences and subsequent improvement in their mental health. The authors were keen to explore the feasibility of applying a standard breath-based yoga intervention coupled with social emotional learning development based on positive findings in other study populations.

The intervention assessed SKY Schools, (formerly the Youth Empowerment Seminar (YES). SKY Schools is an evidence based biopsychosocial program recognized by the Collaborative for Academic, Social and Emotional Learning (CASEL), a program of the United Nations N.G.O. the International Association for Human Values. SKY Schools has been offered in non-clinical settings to over 150,000 youth in North America and is registered in the USA and Canada as SKYSchools.org.

The SKY Schools intervention consists of a cognitive social emotional learning (SEL) curriculum complemented by a series of yoga-based breathing techniques known as Sudarshan Kriya Yoga (SKY). By inducing physiological calm, the SKY breathing techniques might enhance a youth’s ability to learn and execute the SEL strategies taught, especially during periods of high stress when they are most needed.

SKY School’s SEL curriculum is delivered by certified instructors via an interactive, in-person, peer support, multi-modality workshop. This workshop targets five core SEL areas: self-management, self-awareness, social awareness, relationship skills and responsible decision-making (Dacey et al., 2016). Previous research demonstrates that such skill development enhances and promotes positive wellbeing and prosocial behaviors, and reduces the onset of mental health difficulties (Dowling et al., 2019).

Sudarshan Kriya Yoga (SKY) is a standardized series of 3 controlled yoga breath-based techniques including Sudarshan Kriya (described later). There is extensive research to suggest that SKY can offer a useful augmentation strategy to promote wellbeing and to treat various mental health conditions in the adult population including substance use, depression, anxiety and PTSD (Zope & Zope, 2013).

Data on adolescents and young adults, while limited, also shows promise. A randomized controlled trial in a multi-ethnic, non-clinical cohort of older adolescents (mean age: 19.67) in the U.S.A. found significant reductions in depression and stress; and significant improvements in mental health, positive affect and social connectedness (Seppälä et al., 2020). Significant improvements in high school students (mean age: 15.6) were documented in the SEL constructs of self-awareness, self-management, relationship skills and responsible decision making (Newman et al., in preparation; Newman et al., 2020), and young adults who practiced SKY demonstrated significant reductions in depression and stress; and significant improvements in positive affect, emotion regulation, life satisfaction, and social connectedness (Goldstein et al., 2016). Recent clinical trial data from India shows that regular practice of SKY in teens led to significant reductions in emotional, conduct, and peer problems as well as promoted pro-social behavior (Kanchibhotla et al., 2021). SKY has also been found to significantly improve quality of life and depression symptoms in individuals participating in substance use treatment programs (Dhawan et al., 2015; Vedamurthachar et al., 2006).

We examined the feasibility of providing SKY Schools intervention programs to at-risk youth samples in London, Ontario, Canada.

We used a mixed methods approach to determine if a service user’s experiences can be used to further enhance the delivery of SKY Schools for this vulnerable population.

Study Design

We conducted a mixed methods feasibility study which explored delivering an 8-week rolling program of SKY Schools in at-risk youth. The study was approved by the Western University Health Sciences Research Ethics Board approval # 107708 and registered at clinicaltrials.gov NCT0274924.

Participants

Potential participants were screened by trained research staff. Informed consent was obtained from all the participants before beginning any study procedures. Inclusion criteria included youth of age 16-25 years who were either at-risk of homelessness and/or in transition housing, having sufficient hearing to be able to follow verbal instructions, being able to sit without physical discomfort for 30 minutes, willing and able to attend all of the 4 daily initial SKY Schools training sessions and at least 5 of the 7 weekly follow-up sessions. Participants also needed to be willing to dedicate 20 minutes per day to Sudarshan Kriya Yoga (SKY) practice. Individuals were ineligible if they were currently participating in other similar studies or currently practicing any type of formal meditation, mindfulness or breathing techniques regularly.

Recruitment was completed between April 2016 and October 2019. A total of 53 participants were approached and 49 (92%) consented to participate (Table 1 and Figure 1).

Procedures

Participants were recruited via study posters and information sessions offered at YOU as well as key community locations such as libraries and community centres. Posters contained a brief description of the study and contact information for the research team. The information sessions provided individuals an opportunity to meet with members of the research team, learn more about the study, and ask any questions. Interested youth who contacted the research team or attended the information session were invited to attend an upcoming SKY Schools program. SKY Schools programs were held initially at YOU in 2016-17, but due to inadequate recruitment (discussed later), we expanded to additional youth resource centres for refugee and migrant populations in 2018-19.

Trained raters met with participants at the community location where the SKY Schools intervention was held to complete an informed consent as well as collect baseline information (week 0). Additionally, data collection occurred at weeks 4and 8.

Study Intervention

The SKY Schools program was taught in two phases: (1) an active learning phase, which consisted of four consecutive days (3 hrs/day) of social-emotional learning (SEL) skills taught in a multi-modality, interactive format interwoven with SKY training, and (2) a reinforcement phase. The SKY Schools learning phase is constructed around three major modules: Healthy Mind, Healthy Body, and Healthy Lifestyle.

The Healthy Mind Module includes stress management and relaxation techniques, and is designed to foster a positive mental attitude as well as a calm state of mind. It utilizes a series of breath-based yoga breathing techniques, known as SKY. These breathing techniques include (a) Victory Breath- an advanced form of the yogic Ujjayi breath, (b) Bellow’s Breath (termed Bhastrika in yoga literature), and (c) Sudarshan Kriya (SK) or the Rhythmic Breath Technique (for further details see Supplementary File).

The Healthy Body Module includes a program of physical activities to increase flexibility and strengthen the body, along with interactive discussions and experiential processes to encourage mindful eating, healthy nutrition choices and recognize the impact of ingested substances on the body.

The Healthy Lifestyle Module includes further interactive processes and dynamic discussions intended to foster the development of various skill sets such as: emotion regulation and conflict negotiation, resistance skills, problem solving, team-building, relationship skills and goal setting.

The active learning phase was followed by a reinforcement phase which involves follow-up sessions either weekly (90 minutes each) or twice a week (45 min to 60 each) for the subsequent 7 weeks.

Two certified instructors from SKY Schools delivered the program, under the supervision of their Research Director (Ronnie I Newman). After the initial 4-day training, participants were asked to practice SKY daily for 20-25 minutes in addition to attending the weekly follow-up sessions. Full meals were provided at the beginning or end of each training session of the active learning phase.

Focus groups

Upon completion of the rolling SKY Schools intervention groups, all participants were invited to attend a 1-hour focus group directly following the last follow-up session. During each focus group, a member of the research team facilitated the discussions regarding usefulness of the SKY Schools program, and how it could be improved upon. The qualitative results of each focus group were used to provide insight into the feasibility of the program from the point-of-view of the participant, while also allowing the research team to evaluate the program and make changes, if necessary (e.g., changes in duration of the course, topics covered, etc.), as well as the usefulness of the program in promoting social inclusion, improved mental health, and reduced substance use. All focus groups were audio recorded and field notes were collected. Focus groups were carried out in a conversational style, starting with open-ended questions. Participants were later asked to identify what they liked and did not like about the program, what was helpful or harmful and their challenges/barriers along with seeking their suggestion as to how the SKY Schools program could be improved upon. When feasible, the study staff implemented these suggestions in the next groups itself. Further information will be used to improve future SKY Schools intervention.

CAD $20 was offered to each study participant after each interview including the focus group. Hence, if a participant completed all parts of the study, they received $80 in total. Additionally, the cost of public transportation to and from the intervention location was reimbursed upon submission of original bus stubs. Lastly,a nutritious snack or food voucher worth $10 was provided after each weekly reinforcement session.

Measures

The following feasibility outcome measures were collected: (1) number of potential participants approached per month, (2) numbers (proportion) who were successfully screened, (3) proportion of screened participants who enrolled, (4) rate of retention in the study, (5) rate of adherence to study protocol, (6) proportion of planned ratings that were completed, (7) intervention cost per case, (8) completeness of final data for analysis, (9) length of time to collect all data, (10) quality of all collected data, (11) determining if YOU, Canadian Mental Health Association, and other similar community organizations were willing to conduct the study as per study protocol, (12) determining if there were any capacity issues with partners providing intervention and investigators being able to perform the tasks that they were committed to doing, (13) determining if there were be any problems of entering the data into a computer, (14) preliminary data about the safety of the intervention, (15) preliminary estimate of treatment effects (means, proportions, and variance) on clinical rating scales to assess community integration (social inclusion), substance use, and mental health applied at weeks 0, 4 and 8.

The Community Integration Questionnaire (CIQ) consists of two sub-scales. The physical integration sub-scale assesses community involvement by asking participants to indicate yes, no, don’t know or declined to the past month participation in any 7 community activities. The Psychological integration sub-scale assesses the sense of belonging to where one lives and is assessed using a 5-point Likert scale ranging from strongly disagree (1 point) to strongly agree (5 points) for 4 belonging questions. The total score for the psychological integration sub-scale ranges from 4 to 20, with higher scores indicating a greater sense of belonging or psychological integration. Research has demonstrated adequate test-retest reliability and internal consistency (Willer et al., 1994) of the CIQ.

The Global Appraisal of Individual Needs – Substance Problem Scale (GAIN-SPS) measures the recency, breadth, and frequency of any substance use and associated problems. It consists of 13 questions, the first 7 of which request participants to indicate the last time substance use problems occurred with options including past month, 2-12 months ago, 1 or more years ago, never, don’t know or declined. Questions 8 through 13 ask participants to provide specific ages for the onset of substance use, funds spent in the last month and the number of days in the last month experiencing substance use problems. For the purposes of this study researchers utilized a total past month score for questions 1-7 to assess changes in substance use from month-to-month. The GAIN-SPS has demonstrated good internal consistency and test-retest reliability (Dennis et al., 2002).

The Colorado Symptom Index (CSI) assesses overall mental health and consists of 14 Likert scale questions with available options of not at all (score of 0), once during the month, several times during the month, several times a week, at least every day (score of 4), don’t know and declined. Total scores range from 0 to 56 with higher scores indicating more severe mental health symptoms including anxiety, depression, paranoia, suicidality and thoughts of violence. The CSI has demonstrated excellent internal consistency, test-retest reliability and validity across a range of scenarios (Boothroyd & Chen, 2008).

At Week 0, we asked participants to also complete an in-house created demographic, service and housing history (DSSH) questionnaire (Forchuk et al., 2001).

There were no medication restrictions for this study. Recreational drug use was not actively monitored, instead the self-reported frequency of drug use was documented at each assessment using the GAIN-SPS.

Data analysis (Mixed-Methods Design)

The focus of this mixed-methods study was to (1) determine the feasibility of the protocol, and (2) collect qualitative information regarding the usefulness of the program from the youth’s point of view. The methods of analysis for each of the points mentioned above are described below. (1) Study success criteria: If we were able to (a) recruit one participant per week, (b) at least 60% of eligible participants were recruited, (c) retain at least 60% of those enrolled, and additionally if (d) 95% of the retained participants complete study questionnaires and attend focus groups/exit interview; then we would have been successful. (2) The qualitative component of the study used a descriptive-exploratory method to explore perspectives of the participants to better understand their experience of SKY Schools. This helped to identify what participants had liked and disliked about the program, and what might be done to improve future implementation. Data collection took the form of focused group discussions (FGDs) where open-ended questions were asked. FGDs are an effective tool in qualitative research allowing for informal interactions between participants and the facilitator that permit a better understanding of the participants viewpoints on SKY Schools (Fain, 2017). All FGDs followed an interview guide, were audiotaped and later transcribed by a member of the research team.

To understand the perspectives of participants, an inductive thematic analysis rooted in Braun and Clark’s six-phase framework for thematic analysis (i.e., becoming familiar with the data, generating initial codes, searching for themes, reviewing themes, defining the themes, and doing write-up) was completed on the transcribed data. Thematic analysis is a standard flexible method to support descriptive-explorative studies, by identifying underlying themes and patterns in the data (Braun & Clarke, 2006).

Before commencing the analysis, to immerse themselves in the data, two team members independently read through the transcripts while listening to the audio-recording to help find meaning and patterns within the data. These two members of the research team collaboratively performed open coding (i.e., developing and modifying codes as one worked through the data). Once this open coding was completed, the two researchers aggregated the codes and examined them for patterns to create groups and subthemes based on similarity of meaning. After assessing the identified themes for data coherence (within themes) and distinctions (between themes), the subthemes were grouped into major themes. After identifying the major themes, the research team met to discuss and draw conclusions.

Amalgamation of Quantitative and Qualitative Findings

The statistical analysis plan allowed data collection from multiple sources including changes in quantitative data from participants over the 8-week period and comparing it with participant level qualitative data from open focus groups discussions. We believe that this method led to adequate triangulation, an important technique of amalgamating quantitative and qualitative findings, as suggested by Patton 1999.

Primary Outcomes (Feasibility)

We planned to consent up to 60 participants with the aim to retain at least 30 until study completion. This outcome was achieved. A total of 53 potential participants were approached over a period of 36 months, for an average of 1.5 potential participants approached per month. Of those approached n=49 (92.5%) were screened, 100% of which met study inclusion criteria and were hence successfully enrolled (n=49). Of those enrolled, 61.2% (n=30) were retained until study completion. Thirteen (26.5%) withdrew prior to the fourth week of study intervention and 6 (12.2%) prior to the eight week of study intervention (Figure 1).

Data was collected over a period of 38 months. Of the 49 enrolled participants, questionnaires were completed by 48 (98.0%) participants at week 0, 34 (69.4%) at week 4, and 23 (47.0%) at week 8. Data collection took place over a period of 47 months from January 11, 2016 to December 11, 2019. Computer-based data entry was successfully completed with 100% of collected data being entered into the study database.

Quantitative data is represented graphically as trends via Figures 2, 3 and 4.

Two minor protocol deviations were noted during the conduct of the study. Once weekly follow-ups were implemented rather than the planned twice weekly follow-ups. We also offered a snack gift card to the participants in the later part of the study, rather than an actual snack. These changes were made based on suggestions by participants feedback during the initial focus groups.

The calculated cost of the intervention per participant was CAD $176.20.

The Youth Opportunities Unlimited (YOU) community organization, our initial recruiting partner, was willing to conduct the study, however, it was felt that they were unable to provide consistent support to participants and the team. Hence, we determined it would not be possible to meet recruitment goals from this organization alone. Towards this end, we approached two other community organizations including the London Intercommunity Health Centre (LIHC) and the Canadian Mental Health Association (CMHA). The LIHC and CMHA turned out to be enthusiastic partners, working with the study team to provide available appropriate space during a time/date that was felt to be more convenient for participants. The facilitators of the SKY Schools program were able to successfully deliver the intervention, however during the focus groups participants informed study staff that on a few occasions, the intervention facilitators arrived late and in one instance, failed to adequately communicate to study staff and participants that a follow-up SKY Schools session had been rescheduled.

Thirty participants attended focus groups, with group size ranging from n=2-9 and a mean group size of n=6.

No Serious Adverse Events (SAE’s) were reported during the study. Reported adverse effects, by a single participant, included the following a) feeling as if one couldn’t move their hands, b) a sensation of ants walking on the skin, c) being uncomfortable while laying on a yoga mat, d) a headache, and f) muscle soreness. No other adverse events were reported. This study did not utilize a formal method of collecting adverse events, rather questions were posed by the study staff during the focus groups asking each participant to report any perceived harms associated with participating in SKY Schools.

Qualitative Outcomes (Focus Group)

Nine major themes and 42 corresponding sub-themes were identified from the analysis of the focus group transcripts (Table 2). Qualitative results were found to be overall cohesive with the quantitative results. During focus groups participants noted that some participants dropped out of the intervention, identified what they believed were the reasons for withdrawals, some participants expressed an improvement in emotional regulation while others did not, and some enjoyed the social aspect of the program while others felt this needed to be improved. This is consistent with the quantitative findings of a 61% retention rate, non-significant improvement in mental health symptoms, and an unchanged community integration.

The nine major themes and sub-themes are detailed below.

Rewarding Experience

Many participants found SKY Schools to be a helpful technique that led to an improved lifestyle and sense of wellbeing. They found the techniques easy to learn and felt it was a practical tool to establish in their lives. Participants provided a positive response to SKY Schools, indicated it was better than anticipated, found it to be practical and reported an improved lifestyle:

“For me personally I think it was better than I thought it was going to be just because there was such a wide variety of techniques; it wasn’t just focusing on yoga or the mindfulness or the breathing and it kind of encompassed everything, which was nice. So each strategy so to speak, I feel you could either you could do any of those individually and they would all be effective but because we were doing all of them, I felt it bettered the results, and I also felt that the home practice was something easy enough to remember, the order of the movements and the breathing techniques and it wasn’t like it took two hours to do or something. It’s very functional in day-to-day life”.

Improved Emotional Adaptability

Participants reported multiple emotional benefits of SKY Schools including a sense of relaxation and restoration, improved emotional regulation, and improved focus. Participants had a sense of vitality after attending SKY Schools and felt it could be used to cope with daily stressors. Participants indicated that SKY Schools would help them to focus and stay in the present moment:

“It was just relaxing, soothing. I've never done meditation or yoga before. So I was very optimistic, not optimistic, whatever the opposite of optimistic is, I was that I'm just like oh this is going to be ridiculous... yeah skeptical... And I didn't think I was even going to be interested, but after a couple of days...I felt good, felt energized, I felt relaxed...This is a weird hobby of mine, but I go to a graveyard that's already negative. I go to a graveyard and I don't really go to the graveyard to visit anybody. I go there cause there's deer. And then if I can get close to a deer, it feels really peaceful. And you feel like closer to nature, but then as soon as you step outside of that graveyard, you start seeing traffic. You get that feeling like, Oh man, it's time to go back to life. You know? But with the meditation it felt like I was in a forest with deer relaxed, but then when I left, I was like, okay, now it's time to go back to life, but I probably don't want to do that...”

Interpersonal Dynamics

Participants appreciated the atmosphere of the group and the social facilitation it provided, reporting it made them feel more comfortable to try something new, among supportive peers. They expressed that they would have preferred to have a more structured interaction such as a meet and greet and social dining. Participants felt that there was an optimal level of familiarity with their group that would increase comfort without overshadowing the purpose of the program. They identified pre-existing peer relationships as being both helpful and distracting. Participants indicated that gender played a role on their experience in the SKY Schools program and their comfort was increased by the presence of both a male and female facilitator. Study participants were diverse and joined the study with a large spectrum of experiences resulting in different pre-existing levels of trust, including some participants who indicated they lacked trust in others. This pre-existing ability to share and be open, or not, led participants to have different experiences:

“Personally, it takes me a long time to be open and trust people so like actually being able to go and say, ‘well I’m having these problems’ was an issue for me because it’s like talk talking about things that you would talk to a counselor about and then these people you don’t really know anything about. So, it was kind of challenging regardless of if it was one day, two days, it wouldn’t really have made a difference.”

Personal Investment

Participants expressed that the perceived outcome of participating in SKY Schools was proportional to their own level of involvement. They identified that there was a varying level of participation between participants, dwindling participation and a progressive commitment from participants who were retained in the study:

“I think it [number of withdrawn participants] has less to do with the program... I think it has very little to do with how this program is structured. I think it has everything to do with...the types of kids that are involved and then it doesn't matter what it is at that point...I don't think that focusing on how to change it is going to benefit. I think, no matter how it's structured, you're still gonna have people drop off over time... I think that's why a lot of people don't show up because... it [SKY Schools Program] doesn't have any place in the minds, in the greater context of what you're doing”.

Underwhelming or Negative

Participants provided a varied view of their experience in the SKY Schools program. Some participants indicated that no improvement was seen, while others had a tepid attitude toward SKY Schools and indicated their personal growth was stagnant. A few identified facilitators to be too overenthusiastic which was off-putting:

“I personally didn’t really get a lot of benefits from it [SKY Schools]. I did it for about two months and then stopped using it because I wasn’t noticing any differences. I do a general meditation practice on my own that I’ve been doing for like 10 years so I find that more helpful for me.”

Inadequate Coordination

Participants indicated that there were logistical issues which caused significant barriers to attending SKY Schools regularly. These included things such as transportation, time of day for the program, childcare and communication about the program itself. Participants felt they were not provided with an adequate process for reporting and escalating logistical program issues. Participants suggested that improved consistency was needed, the program should start on time, the scheduled time of day for SKY Schools was critical, they were misinformed on the available support and proactive resolutions were needed:

“[Having kids around] was distracting to me too. I felt uncomfortable telling them 'you guys told me I could bring my children and then you would watch them.'

And that’s why I didn’t want to bring my son because I feel it would be more of a distraction. I understand that the childcare is needed and makes sense but maybe if they had a way to find a better block out the window or try and just soundproof the situation.”

Facilitator Influence

Participants believed they would have further benefited from a stricter discipline-based approach. While they identified that participants should be accountable for their own behaviour, they also perceived facilitators were lax in applying discipline.

However, they did also express that the facilitators were largely accessible and supportive:

“It's [SKY Schools] something different as I was already trying to learn meditation with many different points of view. Whereas I was struggling a lot before or trying to learn stuff from the video and trying to learn stuff from just books and videos, this one separate thing. Then being able to just learn personally from somebody... an expert and that I think is the biggest difference for me...That's really what kept me coming back. Cause I mean, I can sit at home and wonder the entire time during this right, I can’t ask questions or anything like that, just being able to be right there. I think that I was already looking for meditation stuff before the course was offered. So it's almost [auspicious] at the same time. And just to be able to have the opportunity to do a free, you know, to some even certain extent more structured, you know. Your classmates, not just the yoga, it's not just the meditation. It was kind of like a little bit more of a different take on that. So I did enjoy that aspect a lot.”

Structural Suggestions

Participants provided feedback on further enhancements for the program including suggestions for improvements to the structure, session duration and reducing disruptive transitions between portions of the SKY Schools program:

“If you had more of not such a big span between [SKY Schools sessions]. If you do like twice a week, because when you do it once a week, there's just that huge time [between sessions]. … But the one thing I found was that with that huge gap in between each session [before the next] follow-up, it was almost too big of one because people would forget. And especially that it was on Monday... Just coming out of the weekend...That's the thing that would really throw people off... Tuesday, Thursday, something during the week, like Monday, you're recovering...But if you did it twice a week, rather than only once a week, I think it would be good. Cause at the beginning, it was consistent. Everybody showed up and I was just like, Oh man, we got quite a group here. It felt more comfortable. I would say either twice a week or try and not do it on the Monday.”

Suggested Enhancements

Participants indicated that they would have enjoyed the SKY Schools program more with some environmental improvements, such as a warmer room. Participants suggested that the location of the program was very important and provided feedback on adverse events including discomfort related to the environment. They identified the value of extrinsic benefits to study participation including study compensation:

“Eventually we started doing the Tims (reference to Tim Hortons, a large chain of Canadian café) cards. I found that to be better. For transportation, I just walk so... going [with] the gift cards to the restaurant there wasn’t a lot of things you can get for that...And the Tims card, like you had the option of getting what you wanted umm as well so if somebody didn’t like a particular food item or couldn’t eat a particular food item, you wouldn’t have to worry about that.”

The study success criteria, as established a priori, were met for participant retention and questionnaire completion. However, this study failed to recruit at the planned recruitment rate of 1 participant per week, rather we recruited at 1.5 participants per month. Our poor recruitment rate likely reflects the nature of the underlying study population. It has been previously demonstrated that it is hard to recruit participants from this population as they are generally found to be distrustful of research studies, feel withdrawn, or are wrapped up in their own difficulties associated with being homeless or at risk of homelessness (Hough et al., 1996). This study recruited from London, Ontario only, which as of July 14, 2021 was reported to have 1,278 people who identified themselves as homeless (Newcombe, 2021), 20% of which are expected to be youth (Gaetz et al., 2014). It may be that to achieve a recruitment rate of 1 participant per week from this population, a future study will need to expand recruitment outside of London. Additionally, it will be important to focus recruitment for potential participants who are at risk of homelessness rather than those who are in transitional housing such as those housed at YOU.

This study recruited a total of 6 cohorts, the first 5 of which ranged in group size from n = 2–9 with a mean group size of 5.6. However, the final cohort enrolled 21 participants. Of these, 20 participants were immigrants and were identified as being at risk of homelessness due to the vulnerability of this population (Preston et al., 2009). Recruitment and retention rates from this cohort was likely higher compared to the initial cohorts.

This mixed methods study utilized focus groups to identify what participants liked or didn’t like about the SKY Schools program and to elucidate how the program might be further improved upon for a future study. Of those who characterised their overall response to YES as positive, there was appreciation of the various components, both the mind-body and cognitive aspects of SKY Schools. Some participants suggested that their experience of SKY Schools was “better than expected” and felt that the fact that it drew from multiple approaches enhanced their experience. Other positive characteristics that participants mentioned were that SKY Schools is practical, and easily integrated into their life, due to its lack of equipment and ability to be practiced anywhere at anytime. It may be possible that participants view the techniques learned through SKY Schools as having reasonable demands given the associated benefits. Another benefit that satisfied participants reported were improved lifestyle habits. These participants thought that the structure of SKY Schools enabled them to create structure in other domains of their life.

Participants reported experiencing relaxation during SKY Schools, and increasingly in their lives as a result of SKY Schools. They reported that the experience of relaxation was most comparable to a sleep state, and that this relaxation was advantageous for their emotional wellbeing. In terms of enhanced emotional wellbeing, participants found it easier to navigate their emotions after attending the SKY Schools intervention.

In terms of negative perception of the intervention, under the theme of inadequate coordination, participants highlighted the importance of their expectations of consistency and punctuality, which may be essential to maintaining and building trust in a provider (Efraimsson et al., 2001). After the completion of the study, we elicited retrospective feedback from the SKY Schools facilitators regarding this reported concern of lack of punctuality. The facilitators reported extreme weather impacting their travel during the winters and scheduling difficulties as the main reasons for some instances of lack of punctuality. Future studies should consider accounting and managing these difficulties.

Another contributor to the perception of inadequate coordination was perceived misinformation about available support such as childcare. Despite lack of any information with regards to provision of childcare during the informed consent process, it appears that this support was indeed a perception amongst the participants. It could be that over the duration of the study, research staff, partnering agencies and/or other co-participants could have offered this wrong information. This misinformation was unfortunate. Nevertheless, future studies should consider provision of childcare as an additional support system to retain participants.

Enhancements suggested by the participants indicated that they were attuned to the sensory environment of the intervention. Participants suggested adding pleasing sounds, and ways to avoid aversive sensory stimulation, such as smell. Temperature was also identified as an important factor. Future research is needed to elucidate exactly the role of sensory environments in relationship to youth development, but in other populations, such as young children with autism, the quality of the sensory environment is an important determinant in engagement with activities (Gentil-Gutiérrez et al., 2021).

Another suggested enhancement included picking a central location, which may have been more convenient for a larger number of participants. The participants also reported valuing the extrinsic benefits of the program, such as food or money. This is echoed in other behaviour change research that extrinsic benefits are valuable insofar as they do not overwhelm intrinsic motivation (Gerhart & Ledford, 2013). This may also have the effect of attenuating stress associated with food or resource instability.

The participants also described how response to the program may be moderated by personal characteristics. They thought this led to differences in personal commitment that changed over time. Some participants also thought that this may be moderated by placing the intervention in the wider social context of participants’ lives. In terms of identity, participants described that participation in the intervention sometimes interfered with other roles or occupational activities. Prompting youth to think about their existing identities or commitments and thinking of ways to integrate the intervention with the other domains of their life may be helpful.

The way that participants characterised their overall responses were varied, from extremely positive to indifference. Participants indicated that participation in SKY Schools led to an improved lifestyle helping them to feel relaxed and restored after practicing the SKY techniques. However, other participants revealed a tepid attitude, as well as the explanation that they had participated in the program because of its novelty. A third participant perspective was the expression of “no change”. Future research on the psychological perspectives or expectancies of participants at the beginning of the program may be helpful to investigate what kind of changes youth may have expected from the program. Participants with a tepid response to SKY Schools also mentioned that they thought that the response to SKY Schools would be moderated mostly by individual factors, and that they would recommend SKY Schools only with knowledge of personal characteristics, as opposed to a global endorsement of the program. One participant felt that the intervention was overly monotonous and lacked the differentiation necessary to advance their skills. It may be that the SKY Schools program is not appropriate for youth who are currently homeless. These youth may be too worried about finding their next meal and a place to sleep to focus on the program. It may be that youth who are currently using illicit drugs may not benefit from the SKY Schools intervention, which requires one to be not only physically present but mentally present.

Participants described three major themes associated with the social environment. They described the integral role of the facilitators on SKY Schools, and the need for inclusivity in terms of facilitators. Participants reported that they thought having facilitators that shared the same gender they identified with was beneficial to learning. Existing peer relationships were also important and can be managed in ways that may be beneficial for participants. Participants suggested improving social dynamics through facilitating familiarity. Facilitators were also important because they play a crucial role in helping youth learn the techniques associated with the program. Participants reported feeling as though the experience was enhanced through the increased availability and willingness of facilitators to answer questions. However, over-control or over-enthusiasm by instructors was received negatively by participants.

This study was not designed to definitively demonstrate the clinical efficacy of the SKY Schools program but rather to assess if it is feasible to later conduct a definitive study. The high level of questionnaire completion by retained participants, the completion of computer-based data entry and the completion of statistical analyses of quantitative data demonstrated that it is feasible to collect data in this study population for demographics, mental health symptoms, substance use and community involvement. Trend analyses of quantitative data suggest beneficial effects of SKY Schools mental health symptoms and a decrease in substance use. These findings need to be replicated in a larger randomized controlled trial.

Limitations

This feasibility study did not include a randomized comparator group, nor was the study powered to make conclusions on the efficacy of SKY Schools in homeless or at risk of homelessness youth. This study did not use a formal scale for the collection of adverse events but rather relied on participant descriptive reports. So far as the team is aware no validated scale for the assessment of adverse events in yoga interventions has been published to date. Attrition in this study was high with 38.8% of participants withdrawing from the study intervention prior to the week 8 follow-up visit. Although this attrition rate was consistent with what the study team anticipated, it may be possible to reduce this attrition rate and increase the reliability of future study results by implementing the suggestions provided by participants during qualitative data collection.

Implications And Future Directions

Future research could also investigate the perspective of facilitators on the strengths and weaknesses of the program, so that changes can be made to enhance participant response or participation. Future studies should consider excluding participants actively using recreational substances. It may also be necessary to focus only on those who are at risk of homelessness and exclude those who are currently homeless. Future studies should seek to include a larger sample size and active comparator group. To increase recruitment and retention it will be imperative to implement suggestions provided by participants. Improvements could include providing a comfortable space (warm temperature and soft yoga mats) to practice SKY Schools, and at a time and location that is convenient for participants. Planning for socialization time to accompany the SKY Schools program in the format of a meet and greet and social dining may help participants to build trust with facilitators and other members of their SKY Schools group. Greater communication about what participants can expect in a future study as well as to whom they should bring their concerns or seek support from could further improve upon the experience of participants. Including facilitators of multiple genders for each program is also seen as important in providing a comfortable and safe environment for participants. Overall participants indicated they were satisfied with the content of the SKY Schools program, and the majority of suggestions were related to administrative aspects of the study intervention. These administrative issues could readily be resolved with suggestions provided by participants and easily implemented in a future study.

If in the future an appropriate validated scale is published for the assessment of adverse events in mind-body interventions, such a scale should be utilized. Study recruitment in such a future study may be improved upon by implementing study sites in multiple cities. It could also be that a member of the study population could act as an advisor at the planning and design stage to help identify better methods of recruiting and retaining in the study.

In summary, this feasibility study demonstrated that it is possible to recruit and retain youth who are homeless or at risk of homelessness for participation in SKY Schools and that it is possible to collect clinical outcome data from this population in such a study.

Ethics Approval and Consent to Participate

The study was approved by the Western University Health Sciences Research Ethics Board approval # 107708 and registered at clinicaltrials.gov NCT0274924.

Consent for publication

Informed consent was obtained from all participants for any publications ensuing from the study.

Availability of Data and materials

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests

Authors have no competing interests.

Funding

This study was supported by an award presented to Akshya Vasudev by the Lawson Internal Research Fund of the Lawson Health Research Institute, London, Canada.

Authors Contributions

AV wrote the initial grant application, supervised research ethics application, supervised collection of data, supervised analysis of data and contributed to manuscript preparation. EI wrote the research ethics application, obtained consent, supervised collection of data and its analysis, contributed to manuscript preparation. JS assisted in data analysis, contributed to manuscript preparation. ATobtained consent, collected data and contributed to manuscript preparation. ACobtained consent, collected data, contributed to manuscript preparation. CWanalysed data, contributed to manuscript preparation. JS contributed to manuscript preparation. MScontributed to manuscript preparation. CFcontributed to manuscript preparation. All authors read and approved the final manuscript.

Acknowledgements

We would like to thank all the participants who took part in this study. We are indebted to and would like to thank Youth Opportunities Unlimited (YOU), London Intercommunity Health Centre (LIHC) and the Canadian Mental Health Association (CMHA) for being valued partners throughout this study. We also wish to acknowledge and express our gratitude for Ronnie Newman for her description of the intervention and Gurnoor Bhatia for proof reading.

Authors Information

The corresponding author was an Associate Professor of Psychiatry and Geriatric Psychiatry at the time of conduct of this study. As of 1^st July 2022, he has left Western University, Lawson Health Research Institute and London Health Sciences Centre. All data that was collected for this study has been securely stored on the servers of Lawson Health Research Institute, London, Canada. All source data files have been archived to a central repository.

Standards of Reporting

When preparing this manuscript, authors followed the guidance for reporting non-randomised

pilot and feasibility studies (https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-019-0499-1)

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Table 1 Demographics of Study Participants at Baseline (n=49)

		n	%
Gender	Female	26	53.1
	Male	21	42.9
	Other	2	4.1
Birth Country	Canada	22	44.9
	Syria	15	30.6
	Iraq	3	6.1
	Libya	3	6.1
	Other	5	10.0
First Language	English	26	53.1
	Arabic	19	38.8
	Kurdish	2	4.1
	Napalese	1	2.0
	Swahili	1	2.0
Employment Status	Unemployed	25	51.0
	Student	20	40.8
	Employed	3	6.1
	Volunteer	1	2.0
Received Treatment for Substance Use	No	44	89.8
	Yes	5	10.2
Ever Been Homeless	No	23	44.9
	Yes	22	46.9
	Declined to answer	4	8.2

n=49

Table 2 Focus Group Themes and Sub-Themes

Major themes	Sub-themes
Personal Investment	Varying participation
	Dwindling participation
	Progressive Commitment
Inadequate Coordination	Improved consistency needed
	Need to start on time
	Timing is critical
	Misinformed on support
	Proactive resolutions needed
Underwhelming experience	No improvement
	Tepid attitude toward SKY SCHOOLS
	Stagnant growth
Rewarding experience	Positive response to SKY SCHOOLS
	Better than anticipated
	Practical
	Improved lifestyle
Improved Emotional Adaptability	Relaxing technique
	Restorative
	Enhanced emotional regulation
	Improved focus
	Increased Resiliency
	SKY SCHOOLS As a coping mechanism
Interpersonal Dynamics	Supportive community (change to Social facilitation)
	Meet and greet needed
	Social dining suggested
	Lack of trust
	Existing peer relationships
	Influence of gender
Facilitator Influence	Accessible facilitators
	Supportive facilitators
	Insufficient support
	Overenthusiastic instructors (change to facilitators)
	Participant accountability
	Program discipline required
	Lax Instructors (change to lax facilitators)
	Rigid dietary options
Structural Suggestions	Improvements to structure
	Appropriate session duration
	Disruptive transition
Suggested Enhancements	Environmental improvements
	Valuing extrinsic benefits
	Good location
	Adverse Effects

YESSupplement20211219.docx

A Feasibility (pilot) Mixed Methods Study of an Innovative Non-Pharmacological Breath-Based Yoga and Social Emotional Intervention Program in an At-Risk Youth Sample in London, Canada

Status:

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Abstract

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What Uncertainties Existed Regarding The Feasibility?

Background

Methods

Results

Discussion

Limitations

Implications And Future Directions

Conclusions

Declarations

References

Tables

Supplementary Files

Status:

Journal Publication

Version 1