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NCT01704560 · ClinicalTrials.gov registry record · NA
Improving Measurement Of Parents' Understanding Of Research Permission
A NA study of Improve Parent Understanding of Research Permission, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT01704560: Completed NA study of Improve Parent Understanding of Research Permission, sponsored by University of Rochester.
NCT01704560 is a NA study of Improve Parent Understanding of Research Permission that has completed, run by University of Rochester. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01704560, a NA study of Improve Parent Understanding of Research Permission, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Primary Outcome
Score on the post-permission DICCT questionnaire. The DICCT is scored on a 28 point scale, with each of 14 parameters being scored as 0 = incorrect, 1 = partially correct, 2 = correct. The DICCT, in addition to being previously validated, has other advantages. It contains questions that are not directly addressed in the cover sheet, but addressed in the full permission form, such as compensation for injury. These items will serve as valuable internal controls. The DICCT is easily adaptable to wr
Conditions Studied
Interventions
- OTHER Coversheet to Informed Consent
Study Locations (2)
New York
- Women and Children's Hospital of Buffalo - Buffalo
- Ann Marie Scorsone - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-03-30 |
| Est. Completion | 2019-04-30 |
| Phase | NA |
What the finished NCT01704560 record still lists
NCT01704560 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Improve Parent Understanding of Research Permission appearing as the primary indexed condition, and to 1 intervention - of which Coversheet to Informed Consent is the first listed.
NCT01704560 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01704560 about?
NCT01704560 is a clinical study titled "Improving Measurement Of Parents' Understanding Of Research Permission". 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 exhaust...
What is the current status of trial NCT01704560?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2012-03-30. Estimated completion is 2019-04-30.
What conditions does trial NCT01704560 study?
This clinical trial studies the following conditions: Improve Parent Understanding of Research Permission.
What interventions are being tested in trial NCT01704560?
The interventions under investigation include: Coversheet to Informed Consent (OTHER).
Who is sponsoring clinical trial NCT01704560?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01704560 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01704560's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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