title: Novel approach to parental permission and child assent for research: improving comprehension.
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.
authors.affiliation: Department of Pediatrics, University of Colorado Denver, 13123 E 16th Ave, B218, Aurora, CO 80045, USA. o'lonergan.theresa@tchden.org
authors.forename: Theresa A
authors.initials: TA
authors.lastname: O'Lonergan
authors.forename: Jeri E
authors.initials: JE
authors.lastname: Forster-Harwood
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D032882:Comprehension; D016001:Confidence Intervals; D003430:Cross-Sectional Studies; D005260:Female; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D008297:Male; D008402:Mass Media / Q000941:ethics*; D033282:Parental Consent / Q000941:ethics*; D010353:Patient Education as Topic / Q000379:methods*; D018579:Patient Selection; D011786:Quality Control; D058996:Quality Improvement; D012107:Research Design; D012307:Risk Factors; D014481:United States