Educational Intervention to Improve Vaccine Acceptance
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Vaccine Hesitancy |
Other: Video intervention along with educational hand out |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
- Change in parental attitude regarding vaccines [ Time Frame: 6-8 weeks ] [ Designated as safety issue: No ]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.
- Vaccination rates of control and interventional groups [ Time Frame: 6-8 weeks, 19 months ] [ Designated as safety issue: No ]Vaccination rates will be compared between groups at both 2 months of age and 19 months of age.
| Estimated Enrollment: | 250 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: routine care | |
| Experimental: Educational intervention group |
Other: Video intervention along with educational hand out
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.
|
Detailed Description:
The intervention is a 8 minute video addressing common concerns that have been reported by vaccine hesitant parents. The video includes an expert in pediatric infectious diseases answering these common questions as well as 3 parental accounts of children who contracted vaccine preventable diseases. Also, the interventional group will be provided with two handouts: one listed information on how parents can find accurate vaccine information on the internet, and another that addresses more common concerns of vaccine hesitant parents and available for our use from the Children's Hospital of Philadelphia Vaccine Center website.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- > 18 years old for parent
- < 30 days old for infant
- full term (>37 weeks gestational age) infant
Exclusion Criteria:
- none
Contacts and Locations More Information
No publications provided
| Responsible Party: | Elizabeth Williams, Research Instructor, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT01385501 History of Changes |
| Other Study ID Numbers: | VA 1111 |
| Study First Received: | March 2, 2011 |
| Last Updated: | November 8, 2012 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 21, 2013