The purpose of this commentary is to outline the challenges encountered when conducting clinical trials of interventions for pediatric traumatic brain injury (TBI) and share potential solutions for surmounting these issues. This commentary grows out of our experience implementing 8 randomized clinical trials (RCTs) of family-centered interventions to reduce child behavior problems and caregiver/parent distress following pediatric brain injury. These studies, involving more than 600 participants from 8 clinical centers, support the feasibility of conducting RCTs with children who have sustained TBIs while highlighting potential challenges and threats to validity. The challenges of behavioral trials for pediatric TBI are apparent but not insurmountable. Careful consideration of the clinical trial issues outlined in this commentary can inform design choices and analyses when planning a clinical trial. It is critically important that investigators share their failures as well their successes to move the field of pediatric TBI intervention research forward.
Division of Physical Medicine and Rehabilitation, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.
Corresponding Author: Shari L. Wade, PhD, 3333 Burnet Ave MLC 4009, Cincinnati Children's Hospital Medical Center, Cincinnati, OH 45229 (email@example.com).
This research was funded by the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR Grant H133B090010). NIDILRR is a center within the Administration for Community Living, Department of Health and Human Services.
Research reported was also partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (CER-1306-02435).
The views presented in this publication, article, are solely the responsibility of the author(s) and do not necessarily represent the views of NIDILRR or PCORI, its Board of Governors or Methodology Committee.
The authors declare no conflicts of interest.