Improving Measurement Of Parents' Understanding Of Research Permission
Public ClinicalTrials.gov record NCT01704560. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaustive information may inhibit rather than promote understanding. Moreover, technical wording in tools used to measure parent understanding of research permission may also lead to inhibition of understanding. This study will test the hypothesis that, among parents of potential subjects for greater-than-minimal-risk research, two modified and simplified subset of questions from the Deaconess Informed Consent Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice, will increase subject understanding of the nature and risks of the research. The study will enroll the parents of 40 potential neonatal research subjects with an interim analysis of data at 20 subjects. Subjects will review a sham research permission form and will be randomized 1:1 to complete one of the two modified comprehension tests in addition to the DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in order to qualitatively describe their opinions of each test. A subset of parents who have received the written form will also undergo a cognitive interview about the form. A similar subset will also be given an open-ended survey about a proposed permission form cover sheet. The primary outcome will be the correlation of scores between the DICCT and modified comprehension tests, following the sham informed consent process.
Study identification
- NCT ID
- NCT01704560
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 32 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2012
- Primary completion
- Dec 30, 2017
- Completion
- Apr 29, 2019
- Last update posted
- Jul 7, 2019
2012 – 2019
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 2
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Women and Children's Hospital of Buffalo | Buffalo | New York | 14222 | — |
| Ann Marie Scorsone | Rochester | New York | 14642 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01704560, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 7, 2019 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01704560 live on ClinicalTrials.gov.