Commentary: Randomized Controlled Trials of Psychological Interventions with Pediatric Populations: The Time has Come and the Journal of Pediatric Psychology is Ready

Abstract

The field of intervention research in pediatric psychology has evolved to the point that there are a sufficient number of controlled clinical trials, especially randomized controlled trials (RCTs), to warrant a special ongoing section of the Journal of Pediatric Psychology (JPP) that will be devoted to this topic. There will be a rolling deadline for this section so that manuscripts can be submitted at any time. We are optimistic that an ongoing section of this Journal will serve not only to highlight RCTs of psychological interventions but also to stimulate publication of the results of RCTs for psychological interventions, which are very much needed in the field of pediatric psychology (McGrath, Stinson, & Davidson, 2003). One reason to develop this special section of the Journal is that controlled intervention studies, especially RCTs, raise difficult methodological, practical, and ethical challenges that need to be considered by researchers, reviewers, and editors. To address this need, the purpose of this special section will be to publish original work in any of the following areas: (a) New data from RCTs of psychological interventions, including preventive interventions, conducted with a range of pediatric populations; (b) Key methodological and data analytic problems involved in RCTs and examples of approaches to their solution; (c) Relevant logistical problems in conducting RCTs in pediatric settings and examples of innovative approaches to their solution; (d) Critical ethical issues in conducting RCTs with pediatric populations and potential approaches to their solution; and finally, (e) Theoretical contributions that relate to development of RCTs with pediatric populations. Relevant manuscripts will include data concerning the results of RCTs, critical reviews, and descriptions, including brief reports concerning pilot and feasibility studies, innovative methodologies and statistical approaches that are applicable to RCTs. As recommended by McGrath et al., (2003) and Stinson, McGrath, & Yamada, (2003), empirical reports of data from RCTs that are submitted to this special section will be expected to conform to the CONSORT statement criteria developed to improve standards of reporting RCTs in medical journals (Altman et al., 2001) and with the five additional CONSORT items that have been proposed for review and reporting of psychosocial interventions (Davidson et al., in press; McGrath et al., 2003; Stinson et al., 2003). The CONSORT criteria were designed to accomplish the following: (a) Improve the quality of the conduct of clinical trials by guiding investigators’ attention to important details including the method of randomization, report of blinding status etc.; (b) Provide important details to be reported in a standard way for readers of journals such as JPP, and facilitate comprehension of these reports by readers; (c) help to make the published data from RCTs more easily retrievable, thus increasing the ease of conducting systematic reviews and meta analyses from articles that report RCTs. It is fitting that Stark and colleagues’ report of RCT designed to increase calcium (CA) intake in children with juvenile rheumatoid arthritis (JRA) is the publication that launches our special section. This study has a number of important features. First of all, it is a preventive intervention trial that was designed to enhance bone mass density in children with JRA who, similar to other children with chronic health conditions such as cystic fibrosis and Crohn’s disease are at greater risk of low bone mass density and hence onset of osteoporosis earlier in their development (Mackner, McGrath, & Stark, 2001). Despite its importance to the field, preventionfocused intervention research has not received sufficient attention in published work in JPP (Kazak, 2002; La Greca, 1997; Roberts, 1992). To address this need,