In-Person vs. Web-Based Administration of a Problem-Solving Skills Intervention for Parents of Children with Cancer: Report of a Randomized Noninferiority Trial

Abstract

Background: Bright IDEAS (BI) problem-solving skills training is an evidence-based intervention designed to help parents manage the demands of caring for a child with cancer. However, the resource intensiveness of this in-person intervention has limited its widespread delivery. We conducted a multicenter, randomized trial with a noninferiority design to evaluate whether a web-based version of BI requiring fewer resources is noninferior to in-person administration. Methods: 621 caregivers of children with newly diagnosed cancer were randomly assigned to standard BI delivered in 8 face-to-face sessions or a web-based version delivered via mobile device supplemented with human support. The primary outcome was caregiver-reported problem-solving skills. The noninferiority margin was defined as 0.2 standard deviation units of the change from baseline to end of intervention. Secondary outcomes included caregiver-reported mood disturbance, depression, and posttraumatic stress symptoms. Findings: The effect of the standard treatment was preserved; parents in the standard BI arm improved their problem-solving (effect size = 0.53, t = 8.88, p 60% of the standard intervention effect on all secondary outcomes; however, tests of noninferiority were non-significant. Interpretation: Noninferiority of web-based BI relative to standard face-to-face administration was not established. Further development of the web-based BI is needed before it can be recommended as a stand-alone intervention. However, the documented benefits of the web-based intervention as well as the advantages of low resource utilization and ease of delivery suggest that further development of web-based BI is indicated, and that it may play a valuable role in alleviating distress in caregivers of children with serious or chronic illness. Trial Registration: ClinicalTrials.gov Identifier: NCT01711944 Funding Statement: The study reported was funded by the National Cancer Institute (U.S.), Grant #: R01 CA159013. Declaration of Interests: None of the authors have any conflicts of interest to report. Ethics Approval Statement: Institutional Review Board approval was obtained at all participating sites and participants provided written informed consent.