Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Educational Intervention to Improve Vaccine Acceptance

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Elizabeth Williams, Vanderbilt University Identifier:
First received: March 2, 2011
Last updated: November 8, 2012
Last verified: November 2012

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

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01385501

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

No publications provided

Responsible Party: Elizabeth Williams, Research Instructor, Vanderbilt University 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 processed this record on March 03, 2015