Educational Intervention to Improve Vaccine Acceptance
1 other identifier
interventional
155
1 country
2
Brief Summary
This research project will develop an educational intervention to improve immunization acceptance by vaccine hesitant parents. This is prospective interventional case-control trial, where the investigators will provide the intervention in the clinical setting. Enrollees will be screened and selected if they meet criteria for "vaccine hesitancy". The investigators will conduct follow up surveys following the intervention to assess change in attitude and follow immunization rates through 18 month well visit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2011
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2011
CompletedStudy Start
First participant enrolled
June 1, 2011
CompletedFirst Posted
Study publicly available on registry
June 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 3, 2015
April 1, 2015
1.8 years
March 2, 2011
April 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change in parental attitude regarding vaccines
Parental attitudes regarding vaccines will be assessed upon screening to determine the parental level of hesitancy regarding childhood vaccines. We will will use the same survey questions again immediately after the intervention and at the 2 month visit to measure change in parental attitude. We will also survey the control group at the 2 month check as well to compare attitude change without the intervention.
6-8 weeks
Secondary Outcomes (1)
Vaccination rates of control and interventional groups
6-8 weeks, 19 months
Study Arms (2)
routine care
NO INTERVENTIONEducational intervention group
EXPERIMENTALInterventions
The interventional group will be shown an 8 minute video addressing common concerns of vaccine hesitant parents. Then, they will be provided with a handout describing how to find accurate vaccine information on the internet and a handout on more common questions from vaccine hesitant parents.
Eligibility Criteria
You may qualify if:
- \> 18 years old for parent
- \< 30 days old for infant
- full term (\>37 weeks gestational age) infant
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Franklin Pediatric Associates
Franklin, Tennessee, United States
University Pediatrics
Nashville, Tennessee, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Instructor
Study Record Dates
First Submitted
March 2, 2011
First Posted
June 30, 2011
Study Start
June 1, 2011
Primary Completion
April 1, 2013
Study Completion
December 1, 2014
Last Updated
April 3, 2015
Record last verified: 2015-04