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A Familiarization Protocol Facilitates the Participation of Children with ASD in Electrophysiological Research

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Evaluation of a prototype interactive consent program for pediatric clinical trials: a pilot study.

Alan R Tait¹, Terri Voepel-Lewis, Maureen McGonegal

¹Department of Anesthesiology, University of Michigan Health System, Ann Arbor, Michigan 48109, USA. atait@umich.edu

Journal of the American Medical Informatics Association : JAMIA

|August 2, 2011

Summary

Interactive consent programs significantly improved parents' and children's understanding of clinical trials. This novel approach enhances comprehension of research concepts and trial details for pediatric participants.

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Area of Science:

Pediatric Research
Clinical Trial Design
Health Literacy

Background:

Traditional written methods for conveying clinical trial information pose challenges for parents and children.
Understanding key research concepts like randomization, placebo, and blinding is crucial for informed consent.

Purpose of the Study:

To evaluate a novel interactive consent program prototype for a pediatric asthma trial.
To assess the program's impact on parents' and children's understanding of clinical trial elements and trial specifics.

Main Methods:

A pilot study involving parents and children reviewing an interactive computer program about a hypothetical pediatric asthma trial.
Pre- and post-program assessments of understanding key research concepts and trial details.
Surveys to gauge user perceptions and satisfaction with the interactive program.

Main Results:

Significant improvements were observed in both parents' and children's understanding of clinical trials and placebo definitions post-program.
Parents' and children's comprehension scores for trial details increased notably after using the interactive program.
The interactive programs were perceived as easy to use and effective in enhancing understanding.

Conclusions:

Interactive media presents a promising avenue for improving the clarity of clinical trial information for pediatric populations.
This novel approach warrants further investigation to optimize informed consent processes in pediatric research.