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Journal of Pediatric Psychology Advance Access originally published online on December 17, 2008
Journal of Pediatric Psychology 2009 34(8):803-816; doi:10.1093/jpepsy/jsn130
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© The Author 2008. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oxfordjournals.org

Conducting a Randomized Clinical Trial of an Psychological Intervention for Parents/Caregivers of Children with Cancer Shortly after Diagnosis

Meredith Lutz Stehl, PhD1, Anne E. Kazak, PhD1,2, Melissa A. Alderfer, PhD2, Alyssa Rodriguez, PhD1, Wei-Ting Hwang, PhD2, Ahna L. H. Pai, PhD1, Alexandra Boeving, PhD1 and Anne Reilly, MD1,2

1The Children's Hospital of Philadelphia, and 2The University of Pennsylvania

All correspondence concerning this article should be addressed to Anne E. Kazak, PhD, ABPP, Division of Oncology, The Children's Hospital of Philadelphia, Room 1486 CHOP North, 34th St and Civic Center Blvd, Philadelphia, PA 19104-4399, USA. E-mail: kazak{at}email.chop.edu


  Abstract

Objective To report acceptability, feasibility, and outcome data from a randomized clinical trial (RCT) of a brief intervention for caregivers of children newly diagnosed with cancer. Method Eighty-one families were randomly assigned following collection of baseline data to Intervention or Treatment as Usual (TAU). Recruitment and retention rates and progression through the protocol were tracked. Measures of state anxiety and posttraumatic stress symptoms served as outcomes. Results Difficulties enrolling participants included a high percentage of newly diagnosed families failing to meet inclusion criteria (40%) and an unexpectedly low participation rate (23%). However, movement through the protocol was generally completed in a timely manner and those completing the intervention provided positive feedback. Outcome data showed no significant differences between the arms of the RCT. Conclusions There are many challenges inherent in conducting a RCT shortly after cancer diagnosis. Consideration of alternative research designs and optimal timing for interventions are essential next steps.

Key words: anxiety; caregivers; intervention; parents; pediatric cancer; posttraumatic stress; randomized clinical trial.

Received April 4, 2008; revision received November 10, 2008; accepted November 13, 2008


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