Considerations in pediatric intervention research: Lessons learned from two pediatric pilot studies

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Date of Original Version



Background and purpose: Pediatric populations represent a vulnerable research group. Careful thought must be given to many factors when designing and implementing pediatric intervention research studies. This article discusses methodological and implementation lessons learned from two pediatric intervention pilot studies and highlights facilitators and barriers encountered. Type of method: Both studies used a pre/post with 6-week follow-up method and were adapted versions of an evidence-based program, Creating Opportunities for Personal Empowerment (COPE). Essential features: COPE is a 7-session, cognitive behavioral skills building intervention. COPE for Asthma was implemented in schools with small groups for elementary-aged children with asthma and symptoms of anxiety. Mindstrong to Combat Bullying was implemented individually in the outpatient mental health setting for adolescents who had experienced bullying with concurrent symptoms of depression/anxiety. Methodological application: Both intervention studies were successful in achieving their research aims, but more importantly the authors learned important lessons in how to successfully work with pediatric populations in research studies. Legal considerations, such as mandated reporting, suicide risk assessment and the inclusion of parents are reviewed. Other components, such as working with children vs. adolescents, integrating research into school-based settings vs. clinic-based settings, and completing intervention research in a group setting vs. individual setting are discussed. Conclusions: The two pilot studies highlight important factors to consider when designing and implementing pediatric intervention studies. While challenges arise in working with this vulnerable population, research is ultimately needed to provide the best evidence-based care for our future generations. Clinical trial registration: The COPE for Asthma study is registered at NCT03481673.

Publication Title, e.g., Journal

Journal of Pediatric Nursing