Participant Recruitment Issues in Child and Adolescent Psychiatry Clinical Trials with a Focus on Prevention Programs: A Meta-Analytic Review of the Literature

Abstract

Introduction: There is a strong need to conduct rigorous and robust trials for children and adolescents in mental health settings. One of the main barriers to meeting this requirement is the poor recruitment rate. Effective recruitment strategies are crucial for the success of a clinical trial, and therefore, we reviewed recruitment strategies in clinical trials on children and adolescents in mental health with a focus on prevention programs. Methods: We reviewed the literature by searching PubMed/Medline, the Cochrane Library database, and Web of Science through December 2022 as well as the reference lists of relevant articles. We included only studies describing recruitment strategies for pediatric clinical trials in mental health settings and extracted data on recruitment and completion rates. Results: The search yielded 13 studies that enrolled a total of 14,452 participants. Overall, studies mainly used social networks or clinical settings to recruit participants. Half of the studies used only one recruitment method. Using multiple recruitment methods (56.6%, 95%CI: 24.5–86.0) resulted in higher recruitment. The use of monetary incentives (47.0%, 95%CI: 24.6–70.0) enhanced the recruitment rate but not significantly (32.6%, 95%CI: 15.7–52.1). All types of recruitment methods showed high completion rates (82.9%, 95%CI: 61.7–97.5) even though prevention programs showed the smallest recruitment rate (76.1%, 95%CI: 50.9–94.4). Conclusions: Pediatric mental health clinical trials face many difficulties in recruitment. We found that these trials could benefit from faster and more efficient recruitment of participants when more than one method is implemented. Social networks can be helpful where ethically possible. We hope the description of these strategies will help foster innovation in recruitment for pediatric studies in mental health.

Primary care-based screening and recruitment for an adolescent depression prevention trial: Contextual considerations during a youth mental health crisis

“…Staffing shortages, particularly in rural and lower-volume clinics ( Anaraki et al, 2022 ), and high demand for mental health resources greatly impacted operations within the inner setting, including available staff for recruitment, perceptions concerning the relative priority of P2P, and concerns about availability of alternative mental health support for those found ineligible. While exacerbated by COVID, these findings are aligned with previously identified barriers to implementing recruitment activities for mental health trials in healthcare settings, such as staff/provider workload ( Jones & Cipriani, 2019 ) and concerns about vulnerability of pediatric populations ( Kilicel et al, 2023 ).…”

“…While all health systems in the P2P trial had at least one site champion, role and organizational position varied, and not all health systems could maintain an active site champion. According to one clinical administrator, internal communication barriers, high staff turnover rate, and the lack of an “on-site” champion initially led to an inadequate understanding of screening and recruitment, as well as the trial purpose overall—another known recruitment barrier for adolescent mental health trials ( Kilicel et al, 2023 ).…”

“…Notwithstanding, a complex eligibility determination process—inherent in most behavioral health trials—continued to result in frequent ineligible determinations. Potential participant ineligibility frustrated some providers and staff and may have affected motivation for presenting the trial to families as an option ( Kilicel et al, 2023 ). Our findings emphasize the need for intentional ongoing assessment at regular intervals, to understand and respond to emerging needs, re-evaluate buy-in, and provide resources and support for issues identified at both the health system and clinic level.…”

Recruitment of adolescents to virtual clinical trials: experiences from the Health4Me clinical trial (Preprint)

“…Virtual clinical trials have the potential to address challenges in traditional site-based recruitment and be cost-effective [20]. Yet, prevention programs among adolescents are known to have the lowest recruitment rates [32], and stakeholders have identified that a prevention lens may not be engaging for adolescents [4]. In the Health4Me Study, a digital preventive intervention, we found that the digital recruitment strategies used were effective, recruiting 390 adolescents in less than 12 months.…”

Fostering Digital Life Skills Through Social Media With Adolescents in 6 German States: Protocol for an Accessibility Study According to the RE-AIM Framework

“…Recruitment complexities arise from stigma and the need to align with adolescents’ varied interests and obtain parental consent [ 35 - 37 ]. Addressing these challenges necessitates multifaceted strategies: empathetic engagement; using diverse channels; and clearly communicating the benefits while ensuring trust, confidentiality, and cultural sensitivity [ 38 , 39 ]. These methods emphasize the need for a supportive and safe environment, messages that resonate with adolescents, and the involvement of the broader community in the recruitment process for prevention programs.…”