Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT04496453
Collaborator
National Institutes of Health (NIH) (NIH)
17
1
1
15.3
1.1
Study Details
Study Description
Brief Summary
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
17 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
Actual Study Start Date
:
Dec 14, 2020
Actual Primary Completion Date
:
Mar 24, 2022
Actual Study Completion Date
:
Mar 24, 2022
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Childhood vaccination decision support tool Participants receive childhood vaccination decision support tool |
Other: Childhood vaccination decision support tool
Participants receive childhood vaccination decision support tool
|
Outcome Measures
Primary Outcome Measures
- Change in knowledge related to childhood vaccinations [pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)]
Assessed using survey
- Change in acceptability of childhood vaccinations [pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)]
Assessed using survey
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
At least 18 years of age
-
Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
-
Fluent in English
Exclusion Criteria:
-
Unable to understand the study objectives, procedures, risks, and benefits
-
Unable to consent for themselves
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke University Health System | Durham | North Carolina | United States | 27710 |
Sponsors and Collaborators
- Duke University
- National Institutes of Health (NIH)
Investigators
- Principal Investigator: Lavanya Vasudevan, Ph.D., Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04496453
Other Study ID Numbers:
- Pro00101904
- 1KL2TR002554
First Posted:
Aug 3, 2020
Last Update Posted:
Jul 15, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University