Vaccine RefusalADEPTNCT04496453
Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
A study testing Childhood vaccination decision support tool in people with Vaccine Refusal, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vaccine Refusal
- What is being tested?
- Childhood vaccination decision support tool
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2020to 24 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
- Fluent in English
Who cannot join
- Unable to understand the study objectives, procedures, risks, and benefits
- Unable to consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
- Conditions
- Vaccine Refusal
- Being tested
- Childhood vaccination decision support tool
- Keywords
- childhood vaccines, vaccine hesitancy, vaccination
- Medical subject headings
- Vaccination Refusal, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Childhood vaccination decision support toolOther
Participants receive childhood vaccination decision support tool
| Study group | Role | What they receive |
|---|---|---|
| Childhood vaccination decision support tool | Experimental | Participants receive childhood vaccination decision support tool Receives: Other: Childhood vaccination decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.
Measured: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Change in Acceptability of Childhood Vaccinations
Measured: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start14 Dec 2020
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vaccine RefusalStudies of the same condition, open and under way.
- More trials run by Duke 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Lavanya Vasudevan, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496453
- Sponsor's protocol ID
- Pro00101904
- Other IDs
- 1KL2TR002554
- Acronym
- ADEPT
- Status last verified
- Apr 2023
- First submitted
- 24 Jul 2020
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations
- ClinicalTrials.gov ID
- NCT04496453
- Acronym / sponsor ID
- ADEPT / Pro00101904
- Conditions
- Vaccine Refusal
- Keywords
- childhood vaccines, vaccine hesitancy, vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Childhood vaccination decision support tool | Experimental | Other: Childhood vaccination decision support toolParticipants receive childhood vaccination decision support tool |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.
- Fluent in English
Key exclusion criteria (2 listed)
- Unable to understand the study objectives, procedures, risks, and benefits
- Unable to consent for themselves
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 |
|---|---|---|
| Childhood vaccination decision support toolParticipants receive childhood vaccination decision support tool | Other | Childhood vaccination decision support tool |
Primary outcome
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.
Change in Acceptability of Childhood Vaccinations
Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vaccine Refusal
Recruiting
Intrahospital Influenza Vaccination in Patients at High Cardiovascular Risk (VACC-UP)
Acute Coronary Syndrome, Heart Failure
Not yet recruiting
Development and Evaluation of a Digital Educational Intervention to Improve Vaccine Confidence and Communication Among Registered Nurses: Protocol for a Randomized Controlled Trial (VaxNurse-RCT).
Vaccine Hesitancy, Vaccine Acceptance
Active, not recruiting
Communication Strategies to Increase HPV Vaccinations
Papilloma Viral Infection, Vaccine Hesitancy
Not yet recruiting
Parents' Knowledge and Attitudes Towards Vaccinating Their Children
Vaccine Hesitancy
Not yet recruiting
A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention
HPV, Vaccination Hesitancy
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.
Lavanya Vasudevan, Ph.D. principal investigator
Duke 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 Childhood vaccination decision support tool in people with Vaccine Refusal, run by Duke 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 3 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 18 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire (time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)). 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 18 Apr 2023.