Educational Intervention to Improve Vaccine Acceptance

Vaccine Hesitancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01385501
• Other study ID #: VA 1111
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: April 2, 2015
• Start date: June 2011
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 155
• Est. completion date: December 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• > 18 years old for parent

• < 30 days old for infant

• full term (>37 weeks gestational age) infant

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccine Hesitancy

Intervention

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.

Locations

Country	Name	City	State
United States	Franklin Pediatric Associates	Franklin	Tennessee
United States	University Pediatrics	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Vaccination rates of control and interventional groups	Vaccination rates will be compared between groups at both 2 months of age and 19 months of age.	6-8 weeks, 19 months	No