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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | No Intervention | Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure. | |
| intervention | Active Comparator | Subjects in this arm viewed a video detailing key elements of informed consent. Subjects in this arm also received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video | Behavioral | Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Comprehension of Informed Consent Process via a scored scale | Structured Interview | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannie Huang, MD, MPH | University of California, San Diego | Principal Investigator |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
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|
| D013676 |
| Technology, Industry, and Agriculture |
| D013690 | Television |