Childhood VaccinationsNCT02851459
Tailoring of Vaccine-Focused Messages: Moral Foundations
A study testing Baseline Survey, Pre-intervention Survey and Morally Congruent Message in people with Childhood Vaccinations, run by Emory University at 1 site in United States.
Trial summary
This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Vaccinations
- What is being tested?
- Baseline Survey, Pre-intervention Survey and Morally Congruent Message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2016
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have at least one child ≤ 12 years of age
- Reside in the United States
Who cannot join
- Have previously participated in this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School Of Public Health - Only Online Recruitment
Atlanta, Georgia, 30322
About this study
Official title: Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 1
This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.
Read the detailed description
Vaccination of young children helps protect this population against a variety of diseases. Children are especially at risk for contraction of and complications from diseases due to their vulnerable immune systems. New evidence-based messages are needed to maintain and increase vaccination uptake among this group. An emphasis on different values is related to decisions parents make about vaccines. The purpose of this study is to develop, implement, and evaluate messages that focus on different aspects of values to impact vaccination attitudes among parents of young children.
Parents emphasize different moral foundations when deciding whether or not to vaccinate children. Based on this research, a messaging intervention with parents of children who are 12 years of age or younger will be conducted. These messages will aid in assessment of how different moral foundations impact attitudes towards vaccination and intent to vaccinate.
This study tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.
- Conditions
- Childhood Vaccinations
- Being tested
- Baseline Survey, Pre-intervention Survey, Morally Congruent Message, Morally Non-Congruent Message, Control Message
- Keywords
- Vaccines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline SurveyBehavioural
The baseline survey contains questions regarding level of existing vaccine hesitancy (Parent Attitudes about Childhood Vaccines (PACV) short scale and HealthStyles questions), demographic information, and intent to vaccinate their children. All study surveys will be completed on an electronic device.
Pre-intervention SurveyBehavioural
Participants will be contacted two weeks after completing the baseline survey to answer questions about their moral beliefs. The survey will include questions form the Moral Foundations Questionnaire as well as additional questions. An algorithm will calculate the participant's moral matrix based on answers to these questions.
Morally Congruent MessageBehavioural
Also called Morally Congruent Vaccine Focused Message
Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. The fourth summarizes the contents of the prior paragraphs.
Participants randomized to the morally congruent arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. The first paragraph focuses on the most emphasized foundation, the second on the third-most emphasized, and the third on the second-most emphasized.
Morally Non-Congruent MessageBehavioural
Also called Morally Non-Congruent Vaccine Focused Message
Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations.
Participants randomized to the morally non-congruent arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. The first paragraph focuses on the least emphasized foundation, the second on the third-least emphasized, and the third on the second-least emphasized.
Control MessageBehavioural
Participants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding.
Post-Intervention SurveyBehavioural
Immediately after reading the randomly assigned message participants will complete a follow-up survey assessing level of existing vaccine hesitancy (PACV short scale and HealthStyles questions) and intent to vaccinate their children.
| Study group | Role | What they receive |
|---|---|---|
| Morally Congruent Message | Experimental | Participants randomized to this arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. Receives: Behavioral: Baseline Survey; Behavioral: Pre-intervention Survey; Behavioral: Morally Congruent Message; Behavioral: Post-Intervention Survey |
| Morally Non-Congruent Message | Experimental | Participants randomized to this arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. Receives: Behavioral: Baseline Survey; Behavioral: Pre-intervention Survey; Behavioral: Morally Non-Congruent Message; Behavioral: Post-Intervention Survey |
| Control Message | Sham comparator | Participants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding. Receives: Behavioral: Baseline Survey; Behavioral: Pre-intervention Survey; Behavioral: Control Message; Behavioral: Post-Intervention Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall change in attitude towards vaccines
Number of caregivers experiencing a change in attitude towards vaccines.
Measured: Week 2
Intent to have their children vaccinated
Number of caregivers opting to have their children vaccinated.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood VaccinationsStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 850 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saad B. Omer, MBBS, MPH, PhD, Emory University
- Investigators
- Saad B Omer, BBS, MPH, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851459
- Sponsor's protocol ID
- IRB00087211
- Status last verified
- Mar 2017
- First submitted
- 28 Jul 2016
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tailoring of Vaccine-Focused Messages: Moral Foundations and Disease Salience - Part 1
- ClinicalTrials.gov ID
- NCT02851459
- Acronym / sponsor ID
- IRB00087211
- Conditions
- Childhood Vaccinations
- Keywords
- Vaccines
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 1 Aug 2016 (estimated)
- 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.
This study is the first phase of a trial examining decision making about vaccines. This phase tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.
Detailed description
Vaccination of young children helps protect this population against a variety of diseases. Children are especially at risk for contraction of and complications from diseases due to their vulnerable immune systems. New evidence-based messages are needed to maintain and increase vaccination uptake among this group. An emphasis on different values is related to decisions parents make about vaccines. The purpose of this study is to develop, implement, and evaluate messages that focus on different aspects of values to impact vaccination attitudes among parents of young children.
Parents emphasize different moral foundations when deciding whether or not to vaccinate children. Based on this research, a messaging intervention with parents of children who are 12 years of age or younger will be conducted. These messages will aid in assessment of how different moral foundations impact attitudes towards vaccination and intent to vaccinate.
This study tests the impact of targeted vaccine-focused health messages on vaccine beliefs held by parents of young children and pre-adolescents. The participant's vaccine beliefs will be assessed at baseline. Two weeks later, the participant's moral matrix will be assessed. A vaccine-related message that appeals to the individual's three most or least emphasized moral foundations will then be presented. Immediately afterwards, vaccine beliefs will be assessed to determine the impact of the message.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Morally Congruent Message | Experimental | Behavioral: Baseline Survey, Behavioral: Pre-intervention Survey, Behavioral: Morally Congruent Message, Behavioral: Post-Intervention SurveyParticipants randomized to this arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. |
| Morally Non-Congruent Message | Experimental | Behavioral: Baseline Survey, Behavioral: Pre-intervention Survey, Behavioral: Morally Non-Congruent Message, Behavioral: Post-Intervention SurveyParticipants randomized to this arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. |
| Control Message | Sham comparator | Behavioral: Baseline Survey, Behavioral: Pre-intervention Survey, Behavioral: Control Message, Behavioral: Post-Intervention SurveyParticipants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have at least one child ≤ 12 years of age
- Reside in the United States
Key exclusion criteria (1 listed)
- Have previously participated in this study
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 |
|---|---|---|
| Baseline SurveyThe baseline survey contains questions regarding level of existing vaccine hesitancy (Parent Attitudes about Childhood Vaccines (PACV) short scale and HealthStyles questions), demographic information, and intent to vaccinate their children. All study surveys will be completed on an electronic device. | Behavioural | Control Message, Morally Congruent Message, Morally Non-Congruent Message |
| Pre-intervention SurveyParticipants will be contacted two weeks after completing the baseline survey to answer questions about their moral beliefs. The survey will include questions form the Moral Foundations Questionnaire as well as additional questions. An algorithm will calculate the participant's moral matrix based on answers to these questions. | Behavioural | Control Message, Morally Congruent Message, Morally Non-Congruent Message |
| Morally Congruent MessageAlso: Morally Congruent Vaccine Focused MessageIntervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. The fourth summarizes the contents of the prior paragraphs. Participants randomized to the morally congruent arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. The first paragraph focuses on the most emphasized foundation, the second on the third-most emphasized, and the third on the second-most emphasized. | Behavioural | Morally Congruent Message |
| Morally Non-Congruent MessageAlso: Morally Non-Congruent Vaccine Focused MessageIntervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. Participants randomized to the morally non-congruent arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. The first paragraph focuses on the least emphasized foundation, the second on the third-least emphasized, and the third on the second-least emphasized. | Behavioural | Morally Non-Congruent Message |
| Control MessageParticipants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding. | Behavioural | Control Message |
| Post-Intervention SurveyImmediately after reading the randomly assigned message participants will complete a follow-up survey assessing level of existing vaccine hesitancy (PACV short scale and HealthStyles questions) and intent to vaccinate their children. | Behavioural | Control Message, Morally Congruent Message, Morally Non-Congruent Message |
Primary outcome
Overall change in attitude towards vaccines
Time frame: Week 2
Number of caregivers experiencing a change in attitude towards vaccines.
Intent to have their children vaccinated
Time frame: Week 2
Number of caregivers opting to have their children vaccinated.
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 Mar 2017.
- Individual participant dataSharing planned: No
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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.
Saad B Omer, BBS, MPH, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Survey, Pre-intervention Survey and Morally Congruent Message in people with Childhood Vaccinations, run by Emory University at 1 site in United States.
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 2 inclusion and 1 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 Mar 2017. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Overall change in attitude towards vaccines (time frame: Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2017.