Healthy ChildrenNCT02957344
Parental Views Related to Colorado State Legislation About Vaccinations, Schools, and Child Care Centers
An observational study of Healthy Children, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Through an online survey, participants will be shown different visual presentations of vaccination data related to schools and child care centers. Participants will rate how important this information is when thinking about their child's health and school choice. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Children
- How many people
- 679 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Nov 2016
- Phase
- Observational
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Mothers of children 12 years of age or younger will be surveyed by email. They will be recruited from a group of women who have previously participated in a paper in-office survey at nine obstetrics/gynecology (OB/GYN) practices across the Front-Range region of Colorado. Women who completed the paper survey and provided contact information for future surveys may be contacted to participate in this survey.
Who may be able to join
- mother of a child 12 years of age or younger
- English literacy to complete the survey
Who cannot join
- respondent has a child of appropriate age but that child will not attend a school or child care center outside of the home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Randomized Trial to Assess Parental Response to Different Presentations of Vaccination Data for Schools and Child Care Centers
Through an online survey, participants will be shown different visual presentations of vaccination data related to schools and child care centers. Participants will rate how important this information is when thinking about their child's health and school choice. Participants will also be asked survey questions about their knowledge of Colorado state vaccination legislation, their opinions and practices related to childhood vaccinations, and their views of a Zika virus vaccine.
- Conditions
- Healthy Children
- Keywords
- health communication, Zika virus, legislation, vaccination, Child Care
- Medical subject headings
- Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Text without context | Not described | |
| Text with context | Not described | |
| Map without context | Not described | |
| Map with context | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey/Questionnaire of parental knowledge and attitudes related to vaccines, schools, and child care centers.
Parental knowledge and attitudes will be evaluated related to legislation regarding schools and child care centers reporting vaccinations in Colorado. Survey is cross-sectional and will be administered to each participant once.
Measured: On average within 2 months of survey invitation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startAug 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ChildrenStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 679 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean O'Leary, MD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957344
- Sponsor's protocol ID
- 11-1149a
- Status last verified
- Jan 2017
- First submitted
- 29 Sep 2016
- Last updated
- 19 Jan 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 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial to Assess Parental Response to Different Presentations of Vaccination Data for Schools and Child Care Centers
- ClinicalTrials.gov ID
- NCT02957344
- Acronym / sponsor ID
- 11-1149a
- Conditions
- Healthy Children
- Keywords
- health communication, Zika virus, legislation, vaccination, Child Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 679 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 7 Nov 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.
Through an online survey, participants will be shown different visual presentations of vaccination data related to schools and child care centers. Participants will rate how important this information is when thinking about their child's health and school choice. Participants will also be asked survey questions about their knowledge of Colorado state vaccination legislation, their opinions and practices related to childhood vaccinations, and their views of a Zika virus vaccine.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Text without context | – | – |
| Text with context | – | – |
| Map without context | – | – |
| Map with context | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Mothers of children 12 years of age or younger will be surveyed by email. They will be recruited from a group of women who have previously participated in a paper in-office survey at nine obstetrics/gynecology (OB/GYN) practices across the Front-Range region of Colorado. Women who completed the paper survey and provided contact information for future surveys may be contacted to participate in this survey.
Key inclusion criteria (2 listed)
- mother of a child 12 years of age or younger
- English literacy to complete the survey
Key exclusion criteria (1 listed)
- respondent has a child of appropriate age but that child will not attend a school or child care center outside of the home
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survey/Questionnaire of parental knowledge and attitudes related to vaccines, schools, and child care centers.
Time frame: On average within 2 months of survey invitation.
Parental knowledge and attitudes will be evaluated related to legislation regarding schools and child care centers reporting vaccinations in Colorado. Survey is cross-sectional and will be administered to each participant once.
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 19 Jan 2017.
- Individual participant dataSharing planned: No
Related trials for Healthy Children
Active, not recruitingObservational study
Electrophysiologic Sleep Phenotyping and Sleep-Dependent Neuro-maturation in Clinical and Healthy Pediatric Populations
Healthy Children, Children With Neurodevelopmental Disorders
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
RecruitingObservational study
Comparison of Individuals With Primary Ciliary Dyskinesia and Healthy Controls
Primary Ciliary Dyskinesia (PCD)
Active, not recruiting
Pediatric Parenting Support in Flint
Healthy, Family Research
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.
Sean O'Leary, MD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Children, run by University of Colorado, Denver 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 19 Jan 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. 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?
Survey/Questionnaire of parental knowledge and attitudes related to vaccines, schools, and child care centers. (time frame: On average within 2 months of survey invitation.). 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 19 Jan 2017; AzTrials last refreshed its copy on 8 Nov 2026.