In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial
In-person vs. web-based administration of a problem-solving skills intervention for parents of children with cancer: Report of a randomized noninferiority trial
Blog Article
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 blue square tablecloth 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 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 gumball bere in alleviating distress in caregivers of children with serious or chronic illness.
Funding: National Institutes of Health (U.S.), R01 CA159013 (P.I.
Sahler).