Conceptual Model
Qungasvik ‘Tools for Life’ is based on a rural Alaska Native Indigenously-designed and delivered prevention model. Our team has written extensively about the development and delivery of a Yup’ik Indigenous theory-driven preventive intervention to reduce risk for suicide and alcohol misuse tailored specifically to the unique culture and context of rural Alaska Native communities in the Yukon-Kuskokwim subregion in southwest Alaska. 56 What we describe here is the process we proposed to adapt the Qungasvik model into the brief BeWeL (Because We Love You) intervention.
The Qungasvik model engages three primary process steps to get to the multi-level outcomes with young people in the rural settings. The first step (Qasgiq; communal house) in the implementation of the model is to come together as cultural leaders and Elders in the community and identify key cultural teachings, practices, and activities that build strengths for young people and give them tools to survive out on the land and in their lives. The next step is identifying key strengths and resources that can be built in young people’s lives through engagement with these specific cultural teachings, practices, and activities (Protective Factors; see Table 1). This process step represents an Indigenous knowledge-driven decision to make an important paradigm shift away from the more standard practice of risk reduction approaches in suicide prevention. The Yup’ik communities and cultural leaders designing the prevention approach felt it was most important to give young people reasons to want to live and to increase their awareness of social connectedness and place in life. The third step (Module Delivery) is the community-driven practice of planning out, delivering, and reflecting upon the cultural activities and teachings that are provided to young people in a series of activities and/or meetings. Finally, the last step (Outcomes) is monitoring the effects of the community-engaged intervention implementation for young people in building strengths, increasing awareness of connectedness, and providing reasons for life and sobriety—all of which, in a Yup’ik cultural framework, ultimately contribute to collective interdependence and well-being.
Table 1
Protective Factors Delivered | Definition | Yup’ik Term |
Affection/Recognition | Recognize and give praise for good behavior and efforts toward helping the family. | Quyavikluku |
Awareness | Being aware of the consequences of one’s own actions and how they affect family and community. | Ellangaq |
Being Treated as Special | Encourage youth to find and fulfill their path by guiding them in a specific direction or cultural role. | Pirpakumalria |
Clear Limits and Expectations | Define acceptable behavior for youth. Expectations are consistently repeated and enforced. | Alerquutet |
Communal Mastery | Confidence that personal problems can be solved by working together with other people, such as family and community members. | Kayuukut |
Family Role Models | Family members lead by example and encourage others to be sober. | Takarnarqellria |
Giving | Sharing with others and contributing to family and community. This cultivates a sense of purpose and responsibility. | Naklegtalria |
Role Model | Non-family members such as elders and community leaders who work hard, live a good, clean and sober life, and share what they know with others. | Nukalpiaq |
Opportunities | Positive things for youth to do to prevent boredom and increase a sense of belonging and purpose. | Ciunerkaat ikirrluku |
Safe Place | Places that are free from substance abuse and violence. Abusive behavior is not tolerated. | Qinuilnguq |
Self-Efficacy | A person’s belief and confidence that he/she can solve their own problems. | Piyugngaunga |
Village Rules | Enforcement of local alcohol laws and youth curfew laws. | Nunam Inerquutai |
Wanting to be a Role Model | Setting an example for others by choosing to live life in a good way. | Ciuliqagcugtua |
Study setting
Our study is based in two Tribal service regions of Alaska: the southwest’s Yukon-Kuskokwim (YK) and the Interior. The YK region has the state’s highest rural Alaska Native population with over 26,000 tribal members residing in 56 villages across a geographic service region that is the size of the state of Nebraska. The Yukon-Kuskokwim Health Corporation (YKHC) is a single-payer health system serving the AN communities in the YK region and is located in the regional hub of Bethel, Alaska (pop. 6600). However, there is no road system connecting any of the communities or the regional hub to outside services in the major cities. Mental health services are scarce outside of the regional hub. Young people in crisis are most often flown into Bethel to be seen in the emergency department by 24-hour on call behavioral health staff, and those in need of ongoing support and care have access primarily through videoconferencing technology with mental health staff in Bethel.
Our second study setting is the Interior region that is serviced by the Tanana Chiefs Conference (TCC), located in Fairbanks, AK. TCC provides a single-payer health system and social services for its 16,000 members throughout the 6 sub-regions and 42 tribes of Interior Alaska. The TCC service region covers an area of 235,000 square miles in interior Alaska, which is equal to about 37 percent of the entire state, and just slightly smaller than the state of Texas. Services for rural residing young people in the Interior are similar in terms of gaps and needs as described above for the YK region. Young people in crisis or engaging in risk behaviors, such as heavy drinking, in Fairbanks and in the rural communities are often sent to the emergency department at the Fairbanks Memorial Hospital. From there, they are either referred out to one of only two psychiatric level inpatient facilities, both located in Anchorage, or they are discharged with a referral back to TCC. Those living in the rural communities have very limited access to follow-up and aftercare. Our study will recruit in Fairbanks, Alaska with an initial focus on engaging emergency department staff at the local hospital along with outpatient behavioral health and social work staff at the local Tribal health and social service organizations. Additionally, we will recruit from other youth-serving agencies including child welfare, the youth shelters, and the AN-serving charter and boarding schools within the region. We will continue to broaden recruitment out to the rural communities to meet enrollment goals.
Participants
Our interventions are targeted toward Alaska Native young people ages 14–24 (N = 370) who present with suicide attempt, ideation, or associated risk behaviors, including alcohol-related injury in the YK region or the Interior. We focus on this age group because suicide is the leading cause of death. 31
Recruitment and consent/assent
In the YK, our study will recruit in Bethel, Alaska with an initial focus on engaging clinical staff and providers in key positions within the Tribal health organization who come into contact with AN young people who are at risk, such as the emergency on-call behavioral health clinicians and hospital social workers. We will also recruit from other youth-serving agencies and organizations in Bethel including child welfare, youth residential facilities, and schools. We will broaden recruitment efforts to rural communities as needed to meet enrollment goals. In the Interior region, our study will recruit in Fairbanks, Alaska with an initial focus on engaging emergency department staff at the local hospital along with outpatient behavioral health and social work staff at the local Tribal health and social service organizations. Additionally, we will recruit from other youth-serving agencies including child welfare, youth shelters, and the AN-serving charter and boarding schools within the region. We will continue to broaden recruitment out to rural communities to meet enrollment goals.
When a young person indicates interest and gives permission, the provider will complete an online consent to contact form. This form collects contact information so that a staff member can contact the parent and/or young person to discuss the project further, obtain consent, and address any questions. Once consent is obtained from those who are 18 or older or from the parent (for those 17 and younger), and we receive assent from those 17 and younger, the young person will then receive a link to complete the baseline survey.
Interventions
In our prior long-term CBPR research experience implementing randomized controlled trials (RCTs) in these communities, our Tribal partners have found our study designs and treatments ethical, particularly for interventions with the potential to reduce risk for suicide in young people. We have a strong evidence base supporting the positive effects of the Qungasvik/TfL approach and for the discussion of social networks among this population. 38,57–61 In this RCT, all young people receive BeWeL (Because We Love You) as described below, and half will be randomized to also receive the motivational interviewing social network intervention (MISN). All young people in the study also receive two follow up virtual visits. Tables 2 and 3 summarize the BeWeL brief intervention activities and protective factors delivered in each section of the 45-minute cultural talk.” Sections are patterned according to four different times during daylight, itself a salient orienting feature that can vary in these communities by over 20 hours over the year. Table 4 summarizes the MISN brief intervention activities.
Brief Adaptation of Qungasvik into BeWeL and Cultural Adaptation to a Different Alaska Native Cultural-Linguistic Group
We proposed to engage AN cultural leaders in the brief intervention adaptation process to accomplish two levels of cultural adaptation to the established Qungasvik model. We initially engaged Yup’ik Alaska Native cultural leaders and young people to adapt the measures and the delivery modality to be more closely tailored to young people who are coming into the intervention from clinical settings. We collectively evaluated the Qungasvik Protective Factors (Table 1) and the Qungasvik Teachings, to co-produce a brief intervention implementation process model delivered virtually by trained AN cultural leaders. Table 2 provides the summary of the BeWeL intervention activities alongside the adapted Qungasvik module.
Table 2. BeWeL Brief Intervention Activities
Table 3. Protective Factors Delivered during the BeWeL Intervention
Table 4
Brief Motivational Interviewing and Social Network Activities
Summary of Activities | Example questions |
Discuss social network and connections people have with one another | • What do you notice about the connections people have with each other? • Are there important people in your life missing from the diagram? |
Discuss people in network that may use substances and how those people may influence the participant | • What do you notice about how people who may use substances are connected to each other? • How do the people in your network who use substances influence you? |
Discuss how participant can avoid using substances if they don’t want to | • If you wanted to avoid drugs or alcohol, what would you have to change in your networks? • Who would be supportive of you making this change? |
Discuss people in network who live a more traditional way of life and how those people can influence participant | • What do you notice about the people in your network who choose to live a cultural or traditional way of life? • What is different about them? |
Discuss how participant can get support to live a more traditional life and connect with their community | • If you wanted to live a cultural or traditional way of life more than you do now, how would you make this happen? • Who in your social network or community would support this? • How can you connect more with your community to help you if you want to live a more cultural or traditional way of life? |
The brief adaptation focuses on delivery of protection and tools for life via a four-part virtual ‘cultural talk’ that draws from teachings based on ancestral strengths, kinship, subsistence practices, survival skills, and social connections with Elders. Protective factors are built through stories, teachings, and reflections with young people by AN community and cultural leaders during these cultural talks. Early on in the brief intervention adaptation process, it was suggested that we rename the brief version of TfL to start with a culturally meaningful phrase, “Because We Love You” (shortened to BeWeL). Elders will often use this phrase when speaking with young people; “We share these words because we love you.” BeWeL as a brief version of TfL is story-based in its delivery and continues to build protective factors that provide tools for life and awareness of connectedness for young people. Figure 1 is the BeWeL logo designed by Garry Utermohle with extensive feedback from young people and the community. Figure 1. BeWeL project logo (designed by Garry Utermohle) The cultural teachings are tailored to the community and region where the young person lives. Protection is considered on multiple levels, including the family, community, and spirituality of a young person along with their own inherent strengths as individuals. Ceremony and prayer are integrated into the virtual space to deepen the sacredness of the work being done and the connections established through space and in communal spirit. Figure 2. Tools for Life step-by-step process Fig. 2 represents the co-produced Brief TfL step-by-step process. The drums each represent one stage of change to explore and reflect upon with a young person during the 45-minute virtual cultural talks. The drums and cultural talk are organized based on an Indigenous conceptualization of the stages of change that begins with establishing a spiritual connection, through prayer and/or ceremony (smudging). A young person is then engaged in reflection on family and ancestral strengths to build awareness of connectedness to the historical resiliencies that they inherit from generations past and present. The cultural talk process then asks young people to consider tools in their toolkit for surviving out on the land. Nature is presented as a primary healing resource and a provider of sustenance for the mind, body, and spirit. Connecting to the land and animals extends a young person’s relational universe. Next, the skills needed to navigate out on the ice and maintain respectful relationships with the animals are translated into everyday life. This translation emphasizes how these skills can also guide a young person through challenges and dangers in their personal lives and can ground their relationships with peers and family. The cultural talk process concludes with an acknowledgement of the central role and purpose that each young person has as part of their own home community, and within the context of the larger Alaska Native community, where they are loved and valued. The stages of change follow the same directional flow at the core of the Qungasvik intervention efforts in developing reasons for life. Young people move through a process of first understanding their dependence on the connections and strengths of their kinship networks. They then move towards independence through an awareness of how protective their culture is and how powerful they are in living their cultural ways of life, and ultimately arrive at an understanding of their interdependence, appreciating both their interconnection and their own inherent, community acknowledged value as a young person in an AN context.
In parallel process of cultural adaptation, our team engaged AN cultural leaders from the Interior of Alaska who belong to Tribes representing Koyukon Athabascan and Gwich’in cultures to assess the acceptability and cultural appropriateness of the BeWeL model for young people from communities culturally distinct from Yup’ik Alaska Native settings, and to provide recommendations for cultural adaptation in content and process of the intervention. The BeWeL model is a flexible, adaptable approach that emphasizes the function of intervention activities in their protective factors delivery over the specific form the activity takes. The protective factors are culturally rooted in Yup’ik communities, but the roots run to the core of AN Indigenous values and are broadly interconnective across different AN cultures and contexts. The teachings can be adapted in form to fit other AN cultural contexts. The cultural leaders conducting the cultural talks in the YK and the Interior bring their backgrounds and connections from their Yup’ik or Athabascan traditions, matching the intervention form of content and protocol to the needs and orientation of each young person, while maintaining the focus of each section. Through these efforts, BeWeL has a cultural congruence across each of the study settings in Alaska.
BeWeL plus MISN
Our prior research has shown the importance of leveraging healthy social networks and cultural connectedness among AN/AI young people to help decrease suicide risk and alcohol and cannabis use. 59,62 For example, our data show that urban AN/AI emerging adults with higher proportions of network members engaging in traditional practices and who do not report heavy alcohol use, regular cannabis use, or other drug use are less likely to report intentions to use cannabis or drink alcohol in the future. 59 Similarly, our work has highlighted that supportive social networks increase protective factors from suicide and alcohol use among rural Yup’ik young people. 62 Based on evidence suggesting the important role that social networks play in changing young people behaviors, particularly in terms of promoting protective factors and reducing risk factors for substance misuse, we proposed a comparative effectiveness RCT study design where half of the young people who enroll in BeWeL will be randomly assigned to receive an additional 15-minute MISN intervention with the cultural leaders following their cultural talk.
The MISN brief intervention is specifically focused on helping young people think through how to decrease risk and increase support in their networks to help them make healthy choices. Leveraging healthy social networks and cultural connectedness among AN/AI young people can help decrease suicide risk and alcohol use, and AN/AI young adults additionally describe the social network (SN) visualizations used in the intervention as engaging and helpful. 63Fig. 3. Example of a social network visualization Fig. 3 provides a visualization example. In the visualization presented to the young person, network members are represented by circles (nodes), and lines between nodes represent network contacts who interacted with each other in the past two weeks. The “Your Network” visualization shows names of people the participant reported interacting with in the past two weeks. The centrality of nodes is conveyed by calibrating node size and color with degree centrality (number of connections the young person had in the past two weeks for a particular node), and line thickness with the participant’s rating of relationship strength between the two nodes. Participants often label groups of members (e.g., the party friends). “Drug and Alcohol Use” shows larger red nodes for people who the young person rates as likely to use substances in the next two weeks and smaller blue nodes for those who are unlikely. “Traditional Way of Life” shows larger green nodes for people who engage in traditional practices and live a more traditional way of life, and smaller blue nodes for people who do not. The accompanying discussion to viewing the visualizations, as guided by the cultural leader, will focus on personal choices, and will draw on roles that networks play in making healthy choices, such as staying connected culturally and ways to increase resilience. Participants will discuss how networks affect choices, and how to address negative influences while retaining and increasing positive elements of their networks. Networks will be discussed again in the two virtual follow up sessions to address where the individual can get support in making healthy choices and engage in traditional practices in their communities.
Intervention fidelity
Fidelity to a culturally-based intervention includes adherence to culture-specific practices that include guidance from Elders and the cultural protocols of engagement rooted in traditional organizational practices. Fidelity to motivational interviewing and the protocol will be monitored through checklists completed by facilitators and through observation of some of the virtual sessions. We will measure adherence to the BeWeL and MISN brief intervention protocols with fidelity checklists with response options ranging from “completely covered” to “not at all covered”. 64–66 Furthermore, before facilitators go into the field, we will provide extensive training on motivational interviewing and the BeWeL and MISN interventions. By the end of training, facilitators will follow the protocol and have a high rate of MI-consistent behaviors and adherence to the protocol. Throughout the study, we will provide supervision and feedback to facilitators on protocol adherence and offer booster training whenever adherence to fewer than 80% of checklist items is observed.
Trial design
This is an RCT with block randomization of 370 young people to BeWeL or BeWeL + MISN. As noted, every young person will receive a cultural intervention, and half will also receive a brief discussion about their social networks using the social network visualization.
Randomization process and study flow
Once consent is obtained, the young person will receive a link to complete the baseline survey. Upon completion of the baseline survey, each participant will be randomized to either BeWeL or BeWeL + MISN. A BeWeL staff member will be notified and provided the randomized treatment group allocation for the young person. The BeWeL staff member will contact the participant to provide the BeWeL or BeWeL + MISN intervention. All participants will be asked to participate in two virtual follow up visits at 2 weeks and 6 weeks after both conditions. They will also be invited to complete 3-, 6-, and 12-month follow up surveys. For each survey administration, detailed information will be obtained on how to reach the respondent (primary address, email, home phone, cell phone, parents' phones, etc.). Figure 4. Participant flow through the study Fig. 4 depicts participant flow through the study, Fig. 5. SPIRIT diagram and Fig. 5 contains a SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) flow diagram of the RCT schedule of enrollment, interventions, and assessments.
Measures
Measures were selected based on prior use, acceptability, and strong psychometric properties in AN/AI or other Indigenous communities. Outcomes will be assessed at baseline, and at 3-, 6-, and 12-months.
Primary outcomes
Suicide intent/risk. The Suicidal Ideation Attributes Scale (SIDAS) 67 is designed to screen individuals in the community for presence of suicidal thoughts and assess the severity of these thoughts. It consists of five items, each targeting an attribute of suicidal thoughts: frequency, controllability, closeness to attempt, level of distress associated with the thoughts, and impact on daily functioning. Responses are measured on a 10-point scale. Items are coded so that a higher total score reflects more severe suicidal thoughts.
Depression. Depression in the last two weeks is assessed using a sum from the 9-item Patient Health Questionnaire (PHQ-9) 68 (0=”not at all” to 4=”nearly every day”; α = 0.92).
Anxiety. Anxiety in the last two weeks is assessed with the 7-item Generalized Anxiety Disorder scale (GAD-7) 69 (0=”not at all” to 3=”nearly every day”; e.g., feeling nervous, anxious, or on edge; α = 0.95).
Alcohol consequences. Consequences from alcohol in the past three months (e.g., passed out) will be assessed by summing 4 items (1= “never” to 7= “20 or more times”) utilized in previous work with this age group. 70
Alcohol use. We will assess alcohol use at each assessment with Monitoring the Future (MTF) items. 71 The consistency and reliability of these measures have been shown in numerous studies. 72–74 At baseline, we will measure lifetime (0 = 0 times, 1 = 1 or 2 times, 2 = 3–9 times, 3 = 10–19 times, 4 = 20–39 times, 5 = 40–99 times, 6 = 100 + times), 3-month (0 = none, 1 = 1 time, 2 = 2 times, 3 = 3–5 times, 4 = 6–9 times, 5 = 10–19 times, 6 = 20–30 times, 7 = 31 + times) and 30-day use (number of days). At follow-up time points, we will measure past 3-month and past 30-day use.
Secondary outcomes
Sobriety self-efficacy. Participants report the likelihood that they could stay sober: 1) in their community; 2) if they are around friends who are drinking; and 3) if their best friend is drinking. Higher scores indicate higher self-efficacy. 75
Intentions to be sober. Participants will be asked if they think they will be sober from alcohol in the next month.
Time spent around peers who use alcohol. Participants will be asked how often they are around peers who drink alcohol from “Never”=0, “Hardly ever”=1, “Sometimes” =2, “Often”=3. 76
Awareness of connectedness (ACS). Nine items focus on assessing awareness of self as a member of a broader human and natural community, including an awareness of connections between one’s own well-being and the well-being of other entities in the various ecological spheres that one occupies (e.g., When I do good things for my community good things happen to me). The ACS assesses the degree to which a person endorses the concept of interrelatedness between self, family, community, and natural environment. 53 Participants respond with a slider from 0 (not at all) to 20 (a lot).
Community and individual protective factors. 62 These items focus on protective factors that occur in the community (e.g., people supported and helped me if I needed it), family, (e.g., my family teaches good values), and within the individual (e.g., working together with friends I can solve many of my problems). Participants respond with a slider from 0 (not at all) to 20 (a lot).
Reasons for life. Reasons for Life (RFL) comprises three subscales: Cultural and Spiritual Beliefs, Efficacy Over Life Problems, and Others’ Assessment (e.g., My Elders teach me that my life is valuable). Higher scores on the RFL are hypothesized to indicate more positive attitudes toward life and higher levels of protection from suicide. 77 Participants respond with a slider from 0 (not at all) to 20 (a lot).
Reflective processes. 78 The Reflective Processes scale taps a culturally patterned type of awareness (ellangneq) used in thinking over potential negative consequences of alcohol misuse engaged by Alaska youth when considering reasons not to drink with eight items (e.g., My friends and I talk about how we have better things to do than go drink). Participants respond with a slider from 0 (not at all) to 20 (a lot).
Social Networks. Social Network Composition and Structure. Participants will complete network interviews at baseline and all follow-up assessments to measure network characteristics and changes using procedures from our previous work79,80 and standard procedures for collecting and analyzing personal networks. 81–83 Participants will be asked to name up to 10 network contacts (“alters”). 84,85 Participants will answer questions about each alter (e.g., demographics, relationship quality, likelihood to use substances) to produce raw data for network composition measures (e.g., percent who engage in substance use). 86 Participants will identify ties among alters to produce raw relationship data to measure network structure (density of ties, average centrality of network members who use substances, etc.). 87,88
Sample size and power
We conservatively compute estimated power for the primary study aim to assess the comparative effectiveness of the BeWeL vs. BeWeL + MISN intervention based on the final projected sample size accounting for attrition at the 12-month follow-up. Based on our previous work, 89,90 we estimate 80% retention at the 12-month follow-up, which will be a final sample of 296 participants at the end of the intervention (n = 148 per arm of the intervention). With these sample sizes, assuming a correlation between repeated assessments of 0.50, four timepoints, and alpha of .05, we have 80% power to detect a standardized effect size (d) of 0.31 between groups and standardized effects size (d) of .22 within groups; thus, we are powered to detect small effects using conventional standards for Cohen’s d.
Data collection methods
Data at all time points (baseline, 3-, 6-, and 12-month) will be collected using web-based surveys. All Record Management System functions will be conducted on RAND’s Survey Research Group’s secure network segment. Computers on the secure network segment are isolated from the rest of the RAND network (i.e., no Internet access, e-mail or file sharing between these computers and the unclassified network) minimizing the possibility of infection by malicious software and unintentional exposure of sensitive data. The computers on the segment will also employ standard password protection along with file and folder permissions limiting access to appropriate project staff.
Aims
We plan to compare the effectiveness of BeWeL versus BeWeL + MISN over a one-year period. In our primary aim, we will compare outcomes between the two groups at 3, 6, and 12 months on suicide risk, alcohol use and consequences, depression, and anxiety. In our secondary aims, we will evaluate the comparative effectiveness of these two groups on sobriety self-efficacy, intentions to be sober, awareness of connectedness, reasons for life, reflective processes, and support from social networks. Finally, we will use qualitative data to provide an in-depth understanding of patient satisfaction of the intervention and participants’ perspectives of culturally centered programming, identifying components valued by the participants and associated with their outcomes.
Statistical methods
We will conduct descriptive statistics and examine missing data. Frequencies will be examined for evidence of sparseness for categorical data and for non-normality (using plots, examination of skewness, kurtosis, etc.) for continuous variables. Where sparseness exists in categorical variables, we will collapse as necessary to produce cell sizes sufficient for analysis. Where non-normality is evident, variables may be transformed. Outliers may be recoded or omitted if necessary. Missing data will be dealt with using multiple imputation and/or full information maximum likelihood estimation. The N of 370 was determined in a priori power analyses to be sufficient to detect small to moderate intervention effect sizes for all primary and secondary outcomes.
Baseline equivalence across experimental groups
We will evaluate comparability of experimental groups with respect to potential confounders. Categorical methods of analysis (e.g., cross tabulations, chi-square) will be used to compare groups for discrete data (e.g., employment, school status). ANOVA or t-tests will be used to test for homogeneity of groups for continuous data at baseline. If a statistically significant difference is found, the covariates will be included in all subsequent analyses. If we observe considerable differences in the experimental groups that cannot be adequately accounted for with the addition of model covariates, we will develop analytic weights using propensity methods to balance the groups.
Primary and secondary outcomes
As a first step, we will examine descriptive statistics. Frequencies will be examined for evidence of sparseness for categorical data and for non-normality (using plots, examination of skewness, kurtosis, etc.) for continuous variables. Where sparseness exists in categorical variables, we will collapse as necessary to produce cell sizes sufficient for analysis. Where non-normality is evident, variables may be transformed or handled through appropriate model estimation. Outliers may be recoded or omitted if necessary. Results from our examination of baseline equivalency will inform the inclusion of covariates in all subsequent analyses in addition to standard covariates. To examine longitudinal change and comparisons between BeWeL and BeWeL + MISN on outcomes, we may use more than one method to analyze the data. One option is to use SAS Proc Glimmix, which can handle both continuous and categorical outcomes as well as accounting for overdispersion and/or zero-inflation as needed using restricted maximum likelihood estimation. Alternatively, we will work within a multigroup latent growth model framework to examine change over the 12-month period using maximum likelihood estimation for continuous outcomes or weighted least square mean and variance (WLSMV) for categorical outcomes as implemented in Mplus. Depending on the preponderance of zeros, type of outcome, and distribution of outcomes, we have the flexibility of using alternative models (e.g., Poisson, zero-inflated Poisson, two-part semicontinuous). In addition to modeling change over the entire study period, we will examine outcomes at each time point (3, 6, and 12 months) using traditional analytic methods (e.g., regression, t-tests). Analyses will be by intention to treat; we will attempt to follow up with all individuals, regardless of attendance. We will examine overall attendance of BeWeL and BeWeL + MISN, and model attendance to detect factors that alter the probability of attending using ordinal logistic regression approaches.
Qualitative methods
Forty participants (20 from each intervention group) will be randomly selected to complete qualitative interviews at 3-month follow up to understand patient satisfaction with the intervention. All interviews will be audio-recorded and transcribed. Verbatim transcripts will be uploaded to NVivo, 91 a collaborative qualitative analysis software. At least two coders will code transcripts using both inductive and deductive coding. 92,93 Open and in vivo coding will be used to establish categories and themes. 94,95 Open coding refers to labeling interview content based on dimensions emerging from it. 93 In vivo coding means assigning code labels using words or short phrases directly from the text. 93 Coding will first occur on a small random sample (20%) of transcripts. Discrepancies will be resolved through team reconciliation. Once a final code list is agreed, we will proceed coding the rest of the transcripts, until we reach reliability (Cohen’s kappa) of at least 0.70. 96,97
Limitations and alternative methods considered
There are some important limitations to our work. First, it is difficult to recruit young people in crisis for multiple reasons. For example, parents may be scared and/or refuse services, and young people cannot be reached while in an inpatient setting. Thus, we have a plan in place to also recruit more broadly across other settings, including hospitals and clinics, outpatient mental health facilities, foster care, schools, and other community settings. Second, BeWeL is a virtual adaptation of a community-based intervention that engaged young people in person in cultural activities. However, young people, especially now following COVID-19 shutdowns, are not engaging in community settings as frequently and many stay at home during community events and engage primarily in online spaces. Thus, BeWel provides a unique opportunity to reach many young people despite not engaging in cultural activities in person. We will also have to think carefully about retention as young people may move around, including out of state, and often change their cell phone numbers. However, our survey research group has an excellent track record of obtaining high retention with difficult to reach populations, and we have several procedures in place (e.g., obtaining contact information at every follow up, and getting additional numbers for contacts) that will help increase retention. Finally, we are not using a neutral control group, thus conclusions about efficacy of the intervention are in reference to our active control group. However, our work in these communities over the last two decades and discussions with our Tribal approval boards emphasized the importance of ensuring that all participants in the RCT received some type of cultural programming.