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Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Not Applicable
Completed
Conditions
Children
Registration Number
NCT02671734
Lead Sponsor
Huang, Jeannie, M.D.
Brief Summary

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.

Detailed Description

IC = informed consent

The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
77
Inclusion Criteria
  • For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
  • Had to be undergoing pediatric endoscopy.
  • English speaking
Exclusion Criteria
  • None.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Evaluation of Comprehension of Informed Consent Process via a scored scaleDay 1

Structured Interview

Secondary Outcome Measures
NameTimeMethod

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