- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01704560
Improving Measurement Of Parents' Understanding Of Research Permission
IMPROVING MEASUREMENT OF PARENTS' UNDERSTANDING OF RESEARCH PERMISSION
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14222
- Women and Children's Hospital of Buffalo
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Rochester, New York, United States, 14642
- Ann Marie Scorsone
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Parents of potential subjects eligible for a NICHD Neonatal Research Network (NRN) interventional trial ("Hydrocortisone/Extubation") or greater-than-minimal risk observational trial ("PROP")
- Permission being sought for a qualifying study
- English speaking
Exclusion Criteria:
- Permission has not been previously sought for another qualifying study
- Illiteracy (unable to read simple forms)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coversheet to Informed Consent
Coversheet attached to Informed Consent.
|
The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application).
The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments.
Each topic will also contain a reference to the page in the consent containing the full description of the topic.
The form is designed to have a reading level no higher than 6th to 8th grade.
Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.
|
No Intervention: No Coversheet
Standard, full permission form, without the coversheet.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DICCT Questionnaire
Time Frame: Within 2 weeks after being approached for participation.
|
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 written answers, which makes it ideal for further modification in future studies. The DICCT will be administered during a structured interview, without a time limit. The parent will be allowed to refer to the permission form to answer the questions. |
Within 2 weeks after being approached for participation.
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 39377
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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