- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06046872
Impacts of a Report-back Training Program
September 13, 2023 updated by: Jennifer Ohayon, Silent Spring Institute
Expanding Effective Report-back of Environmental Exposures Among New Researchers
Researchers participate in a hands-on training program on returning personal exposure results, and pre- and post-tests assess outcomes shifts in knowledge and perspectives on its value, and willingness to implement report-back in current or future studies.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
The investigators study the outcomes from a program that trains researchers to implement report-back, informs perspectives on the value of report-back, increases likelihood of adoption, and promotes insights from visualization of results.
The investigators evaluate the training using pre- and post-tests.
The training program includes an introductory module on ethical and practical benefits and best practices for report-back.
This is followed by a session where researchers gain hands-on practice in report preparation using Digital Exposure Report-Back Interface (DERBI), a digital report-back tool.
Pre- and post-tests assess outcomes related to their prior concerns about report-back, knowledge about report-back, shifts in perspectives on its value, novel insights about data from Researcher- DERBI, and willingness to implement report-back in current and future studies.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Ohayon, PhD
- Phone Number: 6173324288
- Email: ohayon@silentspring.org
Study Locations
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-
Massachusetts
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Newton, Massachusetts, United States, 024600000
- Recruiting
- Virtual and in-person across the U.S.
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Contact:
- Jennifer Ohayon, PhD
- Phone Number: 617-332-4288
- Email: ohayon@silentspring.org
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be affiliated with a study that collects biomonitoring or personal exposure data
Exclusion Criteria:
- Under 18
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Report-back training program
Researchers participate in a training program on sharing personal results.
Pre-and post-tests are administered to evaluate shifts in perspectives and wiliness to report-back before and after the training program.
There is no control group.
|
Researchers participate in a report-back training program to evaluate potential impacts on knowledge and future behaviors with respect to sharing personal exposure results with study participants.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Researcher wiliness to share personal exposure results as measured by pre- and post-tests administered alongside a training program
Time Frame: 3 hours (the training is approximately three hours and pre-and post-tests are administered directly before and after)
|
Investigators are measuring if a training program on sharing personal exposure results impacts wiliness of other researchers to share personal results with participants in their current and future studies.
|
3 hours (the training is approximately three hours and pre-and post-tests are administered directly before and after)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 22, 2023
Primary Completion (Estimated)
December 15, 2023
Study Completion (Estimated)
December 15, 2023
Study Registration Dates
First Submitted
July 13, 2023
First Submitted That Met QC Criteria
September 13, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
September 21, 2023
Last Update Submitted That Met QC Criteria
September 13, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1R21ES032934-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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