A two-arm cluster randomized controlled trial study is planned with an aim of enrolling 480 youth (13-17 years old) to participate from 32 partner agencies (approximately 15 youth per agency). Subjects will be enrolled from 4 cohorts of 6-10 implementation sites in each of four waves quarterly over a year (for a total of 32 sites). Each cohort of six to ten agencies per wave will be systematically paired using agency-level characteristics such as size and youth client demographics. Each agency in a pair will then be randomly assigned to either an implementation condition or a wait-list control condition.
Youth at agencies in the implementation condition will be provided with the Not a Number (NAN) program immediately after baseline measurement, with youth at the wait-list control sites offered a 30-minute mindfulness training program (placebo condition) and an opportunity to receive the program six months later.
Youth at all sites will be provided with information about the study and invited to participate by key contacts at each partner agency. We will work with each partner site to identify optimal strategies for approaching youth and legal guardians about the study given their population of youth, their programmatic structure, and their relationship with families. All caregivers and youth will be informed that participation in the study is voluntary and that all youth who can participate in the NAN program at their agency may do so, regardless of whether they have caregiver consent or provide assent to participate in the research component.
Youth who have caregiver consent, and provide their informed assent to participate, will be enrolled in the study. Using contact information provided to researchers, youth enrolled at all participating agencies will be sent a link by email or text (their preference) to a secure online survey hosted at UNH (Qualtrics). The links will be unique to each youth. Links to surveys will be sent as a text message or email with a generic sounding title (e.g., UNH Teen Survey).
Survey links will be sent to youth at four time points: 1) Prior to any program administration for implementing sites (Baseline survey); 2) Approximately six-weeks after baseline survey administration (and following program administration for implementation site youth) (Six-week follow-up survey); 3) Six months after baseline survey administration (Six month follow-up survey); and 4) Twelve months after baseline survey administration (Twelve-month follow-up survey). Each survey will be designed to take the youth approximately 30 minutes to complete. Youth will be provided with a $20 gift card (e.g., for a locally accessible store like Target or an online store like Amazon) for each survey completed.
Youth from wait-list control condition sites will have the opportunity to receive the NAN program between the six-month and one-year follow-up surveys, providing additional program information on shorter-term outcomes for these youth, while also allowing for longer-term follow-up data on program impact for other youth.
