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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01369394
Other study ID # 186564
Secondary ID
Status Completed
Phase N/A
First received June 7, 2011
Last updated December 8, 2014
Start date June 2011
Est. completion date July 2012

Study information

Verified date December 2014
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goal of this study is to determine whether a computer-based intervention that delivers individually-tailored educational messages about the MMR vaccine increases MMR vaccine-hesitant parents' intentions to have their children vaccinated.


Description:

This will be a randomized controlled intervention trial for MMR vaccine-hesitant parents of children ages six years and younger who have not yet received the MMR vaccine. Parents will complete a three-item measure that assesses their baseline intentions for having their children vaccinated with MMR. Participants will then fill out a short, computer-based survey that assesses demographic factors, prior experience with MMR, and views about a variety of potential barriers to MMR vaccination. Following the survey, the intervention group (40 parents) will view a series of tailored educational messages resembling web pages that uses their survey data to address at an individual level their specific concerns about the MMR vaccine. The control group (40 parents) will view a series of generic educational messages resembling web pages that is similar in appearance to the intervention, but contains only untailored information about the vaccine. After navigating through these educational messages, MMR vaccination intention will be reassessed using the same three-item measure as for the baseline assessment of vaccination intention. The vaccine administration records of the children of these parents will be accessed after parents' participation in the study to assess whether the MMR vaccine was provided to the child.


Recruitment information / eligibility

Status Completed
Enrollment 79
Est. completion date July 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Parent is greater than or equal to 18 years of age

- Parent has a child 6 years of age or younger

- When asked to describe how he/she feels about getting child vaccinated against MMR, parent responds "I don't want to get my child vaccinated" or "I'm unsure if I want my child to get vaccinated"

Exclusion Criteria:

- Cannot read/speak English

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
Behavioral: Computer-based tailoring system
Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will generate educational messages based on participants' responses to survey questions. The intervention group will receive tailored educational messages, whereas the control group will receive generic educational messages. The tailored and generic educational messages will be presented as to look like web pages. However, the messages will only exist on the study computer, and will not be linked to any "live" server or website.

Locations

Country Name City State
United States UMHS Outpatient Pediatrics Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Parent's intention to vaccinate child against MMR Parent will rate his/her intention to have child vaccinated against MMR using a Likert scale before and after the intervention. Date of intervention (one day) No
Secondary Use of the intervention We will assess the number of pages viewed and time spend per page for each participant viewing the intervention. At the time of intervention participation No
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