Trial Registration and Outcome Reporting in Child and Pediatric Psychology: A Systematic Review.

Abstract

To examine rate of registration for randomized controlled trials (RCTs) published in the Journal of Pediatric Psychology (JPP) and Journal of Clinical Child & Adolescent Psychology (JCCAP). Secondary aims were to investigate associations between trial characteristics and registration status and compare registered and published primary outcomes. RCTs published in JPP or JCCAP between January 1, 2007 and December 31, 2017 were included. Secondary analyses of previously published RCTs, meta-analytic, systematic, and narrative reviews, and articles reporting primary aims related to intervention acceptability, feasibility, and/or cost-effectiveness were excluded. Trial registration status, primary registered and published outcomes, dates of registration, participant enrollment and publication, sample size, and country where the trial was conducted were extracted from articles and trial registries. Of 61 RCTs included, 48% were registered. Among registered trials, only 14% were registered before participant enrollment began. Most were registered late (i.e., retrospectively; 86%) in ClinicalTrials.gov (90%). Registration status did not differ based on journal, study sample size, or geographic region where the study was conducted. A greater proportion of trials published in 2013-2017 were registered (61%) relative to those published in 2007-2012 (32%), p = .03. Among registered trials, 57% had discrepancies between registered and published primary outcomes. Findings reveal low rates of prospective registration and considerable risk for incomplete or selective outcome reporting among RCTs published in JPP and JCCAP. Coordinated efforts from all stakeholders involved in the conduct and reporting of clinical child and pediatric psychology research are needed to improve transparent reporting of clinical trials.