In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial

• Main Authors: Sean Phipps, Diane L Fairclough, Robert B. Noll, Katie A. Devine, Michael J. Dolgin, Sasja A. Schepers, Martha A. Askins, Nicole M. Schneider, Kathleen Ingman, Megan Voll, Ernest R. Katz, Jeffery McLaughlin, Olle Jane Z. Sahler
• Format: Article
• Language: English
• Published: Elsevier 2020-07-01
• Series: EClinicalMedicine
• Subjects: Pediatric cancer; Parents; Psychosocial; Intervention; Adjustment; eHealth/mHealth
• Online Access: http://www.sciencedirect.com/science/article/pii/S2589537020301723

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 face-to-face or a web-based version delivered via mobile device. 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. The study was registered with ClinicalTrials.gov Identifier: NCT01711944. 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 < .001). Parents in the web-based BI group also improved their problem-solving (effect size = 0.32, t = 5.32, p < .001). Although the web-based intervention preserved 60% of the standard treatment effect, the test of noninferiority was non-significant (effect size = -0.21, p = 0.55). Similarly, the web-based intervention preserved > 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. Funding: National Institutes of Health (U.S.), R01 CA159013 (P.I. Sahler)