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Randomized Controlled Trial
. 2011 May;127(5):917-24.
doi: 10.1542/peds.2010-3283. Epub 2011 Apr 25.

Novel approach to parental permission and child assent for research: improving comprehension

Theresa A O'Lonergan  1 , Jeri E Forster-Harwood
Affiliations
Randomized Controlled Trial

Novel approach to parental permission and child assent for research: improving comprehension

Theresa A O'Lonergan et al. Pediatrics. 2011 May.

Abstract

Objective: The aim of this research was to test a multimedia permission/assent (P/A) process. The overall hypothesis was that children and their parents exposed to a multimedia P/A process would have better comprehension compared with those exposed to a text-based process.

Methods: Traditional and multimedia P/A processes were created by using an innovative learning-objective approach. A total of 194 parent-child dyads (children aged 11-14 years) were enrolled: 24 dyads in a prestudy testing P/A components for preference and effect on comprehension and 170 dyads in a randomized trial of a multimedia or paper P/A process for a hypothetical study. Participants were predominantly white and were from a metropolitan area served by a tertiary care pediatric hospital and outpatient facility. Comprehension of 8 essential elements of the P/A process was assessed.

Results: The majority of prestudy subjects preferred the video version of the dual-energy radiograph absorptiometry description over the animated and paper versions combined (41 of 48 [85%]; P < .0001), and there were similar results for the abdominal ultrasound description (38 of 47 [81%]; P < .0001). Children exposed to the novel process showed significantly better overall comprehension compared with the paper P/A process (P = .0009), and there were highly significant differences in understanding of study procedures (P = .0002) and risks (P < .0001). The parental multimedia group had significantly better overall comprehension (P = .03).

Conclusions: Multimedia approaches to the research P/A process may improve overall understanding of research participation for children and parents. Improved understanding of study-specific research components (rather than research rights) may improve overall comprehension.

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Figures

FIGURE 1
FIGURE 1
Study schema. Hyp indicates hypothesis; RCT, randomized controlled trial.
FIGURE 2
FIGURE 2
Paper-based assent document.
FIGURE 3
FIGURE 3
Multimedia assent.
See this image and copyright information in PMC

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