Educational Intervention to Improve Vaccine Acceptance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01385501
Recruitment Status : Completed
First Posted : June 30, 2011
Last Update Posted : April 3, 2015
Information provided by (Responsible Party):
Elizabeth Williams, Vanderbilt University

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.

Condition or disease Intervention/treatment Phase
Vaccine Hesitancy Other: Video intervention along with educational hand out Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : June 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2014

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Change in parental attitude regarding vaccines [ Time Frame: 6-8 weeks ]
    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.

Secondary Outcome Measures :
  1. Vaccination rates of control and interventional groups [ Time Frame: 6-8 weeks, 19 months ]
    Vaccination rates will be compared between groups at both 2 months of age and 19 months of age.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01385501

United States, Tennessee
Franklin Pediatric Associates
Franklin, Tennessee, United States
University Pediatrics
Nashville, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University

Responsible Party: Elizabeth Williams, Research Instructor, Vanderbilt University Identifier: NCT01385501     History of Changes
Other Study ID Numbers: VA 1111
First Posted: June 30, 2011    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015