Vaccine HesitancyNCT03395106
Public Health Messages to Address Vaccine Hesitancy
A study testing Parent source, Doctor source and Deliberative content in people with Vaccine Hesitancy, run by University of Manitoba at 1 site in Canada.
Trial summary
Views on vaccines range from those who are strongly supportive to those who are stridently opposed and will not budge from identity-based core beliefs about vaccines. In between these poles are numerous others who can delay, be reluctant (but still accept), or refuse/accept some vaccines for their children but not… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Hesitancy
- What is being tested?
- Parent source, Doctor source and Deliberative content
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 883 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jul 2018to 9 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents over 18 living in Canada with a YOUNGEST child is less than 24 months.
Who cannot join
- Parents who have a YOUNGEST child older than 24 months
- A parent who is pregnant, before the first trimester is complete
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing and Evaluating Public Health Messages to Address Vaccine Hesitancy
Views on vaccines range from those who are strongly supportive to those who are stridently opposed and will not budge from identity-based core beliefs about vaccines. In between these poles are numerous others who can delay, be reluctant (but still accept), or refuse/accept some vaccines for their children but not others. It is for these vaccine-hesitant parents that constitute the 'middle ground' of this spectrum where the most immediate and productive gains can be made towards enhancing vaccination acceptance and improving uptake. However, navigating this noisy communications environment is difficult, given the array of confusing and conflicting information available from multiple and competing sources. To date, there is no consensus on how best to use communication to respond to vaccine hesitancy. Building on two Canada-wide surveys of parents, the goal of this research is to identify which communication strategies show the greatest impact in reducing parental vaccine hesitancy and improving vaccination intentions.
The specific objectives are to:
- Develop and pre-test four variations of news media stories that vary by source (parent versus physician) and content (intuitive versus deliberative);
- Examine the impact of vaccine hesitant parents' exposure to vaccine communications that vary in source (parent versus physician) and content (intuitive versus deliberative) on primary (vaccine hesitant attitudes) and secondary (vaccine intentions) outcomes; and
- Explore which media story variation may be more effective in improving vaccination attitudes and intentions for different parental decision-making styles (deliberative versus intuitive).
- Conditions
- Vaccine Hesitancy
- Being tested
- Parent source, Doctor source, Deliberative content, Intuitive content
- Keywords
- vaccine, public health
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent sourceBehavioural
Having a parent feature prominently in a news story
Doctor sourceBehavioural
Having a doctor feature prominently in a news story
Deliberative contentBehavioural
News story content includes process of weighing the risks/benefits of vaccinating, the importance of vaccines for community protection, and concludes with a recommendation to vaccinate.
Intuitive contentBehavioural
News story content focuses on the consequences of not vaccinating (including vaccine preventable diseases) and the decisional regret.
| Study group | Role | What they receive |
|---|---|---|
| Parent source + intuitive story content | Experimental | Not described Receives: Behavioral: Parent source; Behavioral: Intuitive content |
| Doctor source + intuitive story content | Experimental | Not described Receives: Behavioral: Doctor source; Behavioral: Intuitive content |
| Parent source + deliberative content | Experimental | Not described Receives: Behavioral: Parent source; Behavioral: Deliberative content |
| Doctor source + deliberative content | Experimental | Not described Receives: Behavioral: Doctor source; Behavioral: Deliberative content |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine Hesitancy
Parent Attitudes about Childhood Vaccines (PACV). The PACV is a validated 15 question survey on vaccine hesitancy.
Measured: Change in baseline measured up to 1 day after content delivery
Secondary outcomes (1)
Intention to Vaccinate
intention to vaccinate item using a 5 point likert scale ranging from very unlikely to vaccinate to very likely to vaccinate, and see if there is a one-response shift in participant intentions among vaccine hesitant parents.
Measured: Change in baseline measured up to 1 day after content delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study start9 Jul 2018
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaccine HesitancyStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial design 2x2
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 883 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Immunization Research Network
- Responsible party
- Sponsor
- Investigators
- Michelle Driedger, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395106
- Sponsor's protocol ID
- H2016:390
- Status last verified
- Oct 2019
- First submitted
- 12 Dec 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pachur T, Spaar, M. Domain-specific preferences for intuition and deliberation in decision making. Journal of Applied Research in Memory and Cognition. 4:303-311, 2015.
Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr. 2013 Nov;167(11):1065-71. doi: 10.1001/jamapediatrics.2013.2483.
PubMed 24061681
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Evaluating Public Health Messages to Address Vaccine Hesitancy
- ClinicalTrials.gov ID
- NCT03395106
- Acronym / sponsor ID
- H2016:390
- Conditions
- Vaccine Hesitancy
- Keywords
- vaccine, public health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 883 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Canadian Immunization Research Network
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 10 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Views on vaccines range from those who are strongly supportive to those who are stridently opposed and will not budge from identity-based core beliefs about vaccines. In between these poles are numerous others who can delay, be reluctant (but still accept), or refuse/accept some vaccines for their children but not others. It is for these vaccine-hesitant parents that constitute the 'middle ground' of this spectrum where the most immediate and productive gains can be made towards enhancing vaccination acceptance and improving uptake. However, navigating this noisy communications environment is difficult, given the array of confusing and conflicting information available from multiple and competing sources. To date, there is no consensus on how best to use communication to respond to vaccine hesitancy. Building on two Canada-wide surveys of parents, the goal of this research is to identify which communication strategies show the greatest impact in reducing parental vaccine hesitancy and improving vaccination intentions.
The specific objectives are to:
- Develop and pre-test four variations of news media stories that vary by source (parent versus physician) and content (intuitive versus deliberative);
- Examine the impact of vaccine hesitant parents' exposure to vaccine communications that vary in source (parent versus physician) and content (intuitive versus deliberative) on primary (vaccine hesitant attitudes) and secondary (vaccine intentions) outcomes; and
- Explore which media story variation may be more effective in improving vaccination attitudes and intentions for different parental decision-making styles (deliberative versus intuitive).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Factorial design 2x2
| Arm | Type | Receives |
|---|---|---|
| Parent source + intuitive story content | Experimental | Behavioral: Parent source, Behavioral: Intuitive content |
| Doctor source + intuitive story content | Experimental | Behavioral: Doctor source, Behavioral: Intuitive content |
| Parent source + deliberative content | Experimental | Behavioral: Parent source, Behavioral: Deliberative content |
| Doctor source + deliberative content | Experimental | Behavioral: Doctor source, Behavioral: Deliberative content |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parents over 18 living in Canada with a YOUNGEST child is less than 24 months.
Key exclusion criteria (2 listed)
- Parents who have a YOUNGEST child older than 24 months
- A parent who is pregnant, before the first trimester is complete
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent sourceHaving a parent feature prominently in a news story | Behavioural | Parent source + deliberative content, Parent source + intuitive story content |
| Doctor sourceHaving a doctor feature prominently in a news story | Behavioural | Doctor source + deliberative content, Doctor source + intuitive story content |
| Deliberative contentNews story content includes process of weighing the risks/benefits of vaccinating, the importance of vaccines for community protection, and concludes with a recommendation to vaccinate. | Behavioural | Doctor source + deliberative content, Parent source + deliberative content |
| Intuitive contentNews story content focuses on the consequences of not vaccinating (including vaccine preventable diseases) and the decisional regret. | Behavioural | Doctor source + intuitive story content, Parent source + intuitive story content |
Primary outcome
Vaccine Hesitancy
Time frame: Change in baseline measured up to 1 day after content delivery
Parent Attitudes about Childhood Vaccines (PACV). The PACV is a validated 15 question survey on vaccine hesitancy.
1 secondary outcome
Intention to Vaccinate
Time frame: Change in baseline measured up to 1 day after content delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- BackgroundPachur T, Spaar, M. Domain-specific preferences for intuition and deliberation in decision making. Journal of Applied Research in Memory and Cognition. 4:303-311, 2015.
- Background: PubMed 24061681Opel DJ, Taylor JA, Zhou C, Catz S, Myaing M, Mangione-Smith R. The relationship between parent attitudes about childhood vaccines survey scores and future child immunization status: a validation study. JAMA Pediatr. 2013 Nov;167(11):1065-71. doi: 10.1001/jamapediatrics.2013.2483.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Driedger, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent source, Doctor source and Deliberative content in people with Vaccine Hesitancy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine Hesitancy (time frame: Change in baseline measured up to 1 day after content delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03395106, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.