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Youth and family members make meaningful contributions to a randomized‐controlled trial: YouthCan IMPACT

Abstract Background There are growing calls to engage service users in research about issues relevant to them. Youth and family members can make meaningful contributions to research projects, improving quality and relevance. However, more information is needed on the contributions that youth and family members can make to various study designs. Objective This paper describes the contributions that youth and family members have made to a multi‐site pragmatic randomized‐controlled trial, YouthCan IMPACT, and the way project‐based engagement learnings accelerated change at the institutional level and beyond. Results Youth and family members were full members of the project team, including the project's core governance and working groups. They contributed to project leadership, as funding co‐applicants and as equal members of the governance team. They were also engaged in study design. Youth defined the primary outcome measure and contributed to decisions on all secondary measures. The service pathway was co‐designed with youth and family members; for example, they guided the inclusion of peer support and a family member intervention as core service components. Study implementation contributions included ensuring a youth‐ and family‐friendly research process and training research staff on working with youth and family members. Knowledge translation activities have included youth and family members as co‐presenters and manuscript co‐authors. The learnings from this trial have been leveraged to expand youth and family engagement at the institution and beyond. Conclusions Youth and family members make substantial contributions to complex research projects, including randomized‐controlled trials, thereby improving project design, study implementation, associated interventions, and knowledge translation.


| BACKGROUND
It is increasingly considered essential to engage individuals with lived experience in all stages of research projects examining issues relevant to them, to improve research quality and relevance (Banner et al., 2019;Bell, 2015;Kirshner et al., 2005; Ontario Centre of Excellence for Child and Youth Mental Health, 2016). Engagement frameworks have been developed, including Canada's Strategy for Patient-Oriented Research (SPOR; Canadian Institutes of Health Research, 2015), the United Kingdom's National Institute for Health Research (INVOLVE, 2012), and the American Patient-Centered Outcomes Research Network (Patient-Centered Outcomes Research Institute, 2018). Integrated knowledge translation is a framework that calls for the active engagement of end-users and other stakeholders in research to foster uptake Gagliardi et al., 2017).
In research regarding young people, youth engagement is of paramount importance since there can be a gap between the realities facing young people and the experiences of researchers. Youth can be engaged as full partners in research activities Kirshner et al., 2005). We, as a team, refer to 'youth engagement' rather than 'patient engagement', as this term is preferred by young people and is more consistent with the framework of engagement; that is, youth do not have to be registered patients of a healthcare institution in order to provide feedback on youth issues and services.
In addition to youth engagement, it is also important to engage family members, or caregivers, as they play important roles in treatment decisions (Bannon & McKay, 2005;Logan & King, 2001). Engagement and integrated knowledge translation frameworks recognize the skills and expertise that these important stakeholders can bring to research and decision-making processes (Gagliardi et al., 2017;Heffernan et al., 2017;Nguyen et al., 2019).
While there is a growing literature describing patient-led projects, youth-led projects, participatory-action research, and qualitative studies (Domecq et al., 2014;Iwasaki et al., 2014;Sarah et al., 2016), there is a paucity of literature on engagement in research designs such as randomized-controlled trials. It is important to recognize that youth and family members can contribute to a wide variety of study designs, and their involvement should not be limited to certain designs over others. For example, across study designs, they support researchers in identifying research questions and interpretations that address the experiences most relevant to the target population. They can also help ensure that studies are designed in ways that are appealing and experientially appropriate for the target audience, fostering participation, satisfaction, and retention. To support the scale-up of engagement across areas of research, there have been calls for researchers to share engagement experiences and impacts with research communities (Nguyen et al., 2019).
The YouthCan IMPACT project is a pragmatic randomizedcontrolled trial (RCT) and integrated youth service (IYS) development project  operating out of the Centre for Addiction and Mental Health (CAMH) in Toronto, Canada. The IYS model is a one-stop-shop model of community-based care for youth wellness, including supports for mental health, substance use, and other areas of wellness. It is an integrated, collaborative care team model bringing together a wide range of interventions and care providers, including social workers, psychiatrists, nurse practitioners, peer support workers, care navigators, and other contributors to the service pathway. IYSs provide a variety of co-located, evidence-informed services to meet a wide range of youth needs.
In this complex, multi-site RCT, youth and family members were engaged throughout, from the grant application to knowledge translation. Prior to funding, youth and family members were consulted to help shape the project. As the YouthCan IMPACT project advanced, a governance model was established; the project was governed by a National Youth Action Council (NYAC). One lead family member with lived experience of supporting a youth was a regular team member and co-investigator, but was not a staff member. Additional family members with family lived experience supported specific processes throughout the study, for example as members of the community working group. The lead family member also connected with a broader group of family representatives in a Family Member Advisory Committee (FMAC). Through these mechanisms, both youth and family members made substantial contributions to the project. Youth and/or family engagement were prioritized for each project activity based on whether the primary end-user was a youth or family member. By establishing a climate of open, honest, and respectful discussion and building strong relationships, opinions were discussed and consensus was achieved across stakeholder groups through the course of the project. The team's experience of engagement, including the successes and challenges of the engagement process, are described in Sheikhan et al. (2021).
This article describes contributions that youth and family members made to the YouthCan IMPACT project. The purpose is to highlight the ways in which engagement improved the quality of the project, stimulating thought about how youth and family members can contribute to diverse research projects. An overview of youth and family member contributions is provided in Table 1.

| Project leadership and vision
Prior to obtaining funding and fully implementing the engagement model, ongoing youth consultations helped shape the project vision.
Youth were consulted at pre-funding, when they co-developed our flexible model of engagement, while also emphasizing the importance youth engagement in the service delivery model via peer support.
They also advocated for developing an easy-to-access service delivery model that includes crisis supports and holistic supports, building on our vision of what IYSs would offer. Youth were involved in the successful grant application; two YEFs were co-applicants and helped shape the vision through regular attendance at project design meetings, in conjunction with integration of the recommendations provided during the youth consultations. Once funding was awarded and project work proceeded at a faster pace, YEFs became regular members of the project's Core Team, ensuring that youth voices were paramount during all project discussions. From developing overarching strategies to overseeing timelines, YEFs were present at meetings with the scientists, site representatives and the broad project team.
The overarching project vision was enhanced by the YAG members, who developed core values to guide the research and clinical processes and created associated values posters that are prominently displayed in the research and service settings (see Figure 1). These were developed in a YAG meeting in which youth attendees brainstormed together on the values that should drive the project.

| Study design
Youth contributed substantially to the research methods development process. In the early development phases, youth defined the primary research outcome-functioning-which they considered more important than diagnostic symptomatology and which makes the study more closely aligned with youth values. YEFs attended regular meetings of the Methods Group, where they provided insights about each potential outcome domain, correlate construct, and measurement tool, ensuring face validity and that measures resonate with participants, which may foster completion. They advocated for the inclusion of secondary outcomes such as empowerment and engagement as participants progressed through the service pathway; this led to the addition of measures for these constructs and will lead to reported outcomes that align with these youth values. The selection of measures occurred through a reciprocal process, where the youth identified outcomes of interest, the researchers identified relevant measures, and potential measures were discussed together among the youth and researchers.

| Study implementation
YEFs and YAG members emphasized the importance of ensuring youth-friendly research processes. They made many suggestions that were incorporated into the study visit procedures, such as offering snacks and activity packages (colouring, word searches, origami), which created a relaxed and less clinical atmosphere. Youth trained the research staff in working with participants in an appropriate, youth-friendly manner, emphasizing for example the importance of asking which pronouns to use and when (e.g., in contexts with and without family members present), considering potential disability accommodations, youth autonomy in decision-making, and other important aspects of working with youth. The YEFs played the role of participant in mock participant visits, which supported the staff in developing their communication and interviewing skills and youthappropriate language choices. The research staff found these trainings to be highly beneficial, and high satisfaction ratings from youth participants for study visits suggest that this process was successful.
The YEFs regularly provided feedback on the wording of study scripts and materials used on a daily basis, attending to reading level and ease of understanding. They also co-developed participant-facing study educational materials. Together, these contributions led to a smooth research implementation process, with strong participant retention and minimal challenges to address during the course of the study.

| Service pathway design
YEFs were full members of the Community Group, where they con- apps. The youth team thereby substantially contributed to designing the youth-friendly, appropriate service pathway that the study tests.

| Knowledge translation
YEFs have been involved in multiple knowledge translation activities, such as co-authorship on manuscripts , including the current manuscript, co-presentation at conferences, and co-facilitation of a project webinar (Cleverley et al., 2016

| Project leadership and vision
During the initial project development phase prior to funding, family members of youth with mental health or substance use challenges were consulted to help shape the project vision. They emphasized the importance of using a one-stop-shop team-based approach; incorporating peer support, care navigation and family member services; and engaging family members throughout the project. For the successful funding application, the lead family member was a co-investigator and contributed to design discussions. This lead family member was a regular member of the Core Team and ensured that the team kept family member concerns in mind throughout planning. Their feedback was also considered in developing study scripts.
Strong study visit satisfaction rating by family member participants attest to the positive impacts of their contributions.

| Service pathway design
Family member representatives were ongoing members of the Community Group, where they co-created the clinical service pathway.
This included the lead family member and other family members over the course of the project. Family members emphasized including a diversity of intervention components. Notably, both the FMAC and the family team members emphasized the importance of providing services for family members, since the wellbeing of family members is intertwined with youth wellbeing. Since the lead family member was a leader of an organization delivering the Family Connections intervention Hoffman et al., 2005), which is an evidencebased program based on the principles of dialectical behavioural therapy and is designed specifically for family members and delivered by family member peers, the lead family member offered to bring this to the service pathway. Family Connections thereby became a core component of the service pathway. In addition to this major contribution, family member representatives provided feedback and guidance in coconstructing all aspects of the service delivery model.

| Knowledge translation
The lead family member was involved in multiple knowledge translation activities, such as manuscript co-authorship Sheikhan et al., 2021), including the current manuscript, conference presentations, and webinar co-facilitation (Cleverley et al., 2016 Krause et al., 2021), survey studies (Hawke, Barbic, Voineskos, et al., 2020), randomized-controlled trials (Wiljer et al., 2020), Delphi studies (Cleverley & Rong, 2018), longitudinal studies (Cleverley, Bennett, et al., 2020), discrete choice experiments (Hawke, Hayes, Iyer, et al., 2020), qualitative designs (Cleverley, Lenters, & McCann, 2020), pilot studies (Courtney et al., 2019), clinical pathway development , and more, including Centre-based, province-wide, and pan-Canadian studies. The youth team has undertaken a youth-led research project (Syan et al., 2021) and led components of other projects. They also support multiple While a growing body of literature is demonstrating the importance and impact of engagement (Banner et al., 2019;Bombard et al., 2018;INVOLVE, 2012;Laurance et al., 2014;Sheikhan et al., 2021), future research is required to test the impact of engagement models. It is important to continue delineating the role and experience of engagement in diverse research projects as a way to guide researchers in engagement processes (Faithfull et al., 2019;Forsythe et al., 2019;Sheikhan et al., 2021). However, pushing engagement endeavours to a more advanced level requires conducting trials of engagement, explicitly evaluating the impact of engagement on the success of research projects; researchers should consider metrics such as study recruitment and retention success, participant experience, and study outcomes, as well as metrics to be determined in collaboration with engaged individuals. Robust nomenclature and data collection strategies are required to rigorously define the impact of engagement in research on a wide range of metrics. As calls for engagement expand, institutions, research funders, research ethics boards, and peer-reviewed journals are encouraged to value and require appropriate engagement strategies when making important decisions about research, acknowledging the pivotal role that engaging individuals with lived experience can have in designing and conducting efficient, relevant, and appropriate research projects (Forsythe et al., 2019;.
Youth and family members can make substantial contributions to complex research projects, beyond participatory-action communitybased designs, including randomized-controlled trials and other research designs. Robust engagement improves project design, study implementation, associated interventions, and knowledge translation.
Researchers are encouraged to consider the impacts that youth and family members can make to their research projects and develop or expand upon their engagement models to optimize the quality of their research work.