COVID-19 VaccinationCONFIDENCENCT05722652
A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
A study testing CONFIDENCE in people with COVID-19 Vaccination, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccination
- What is being tested?
- CONFIDENCE
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 667 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2023to 31 Oct 2024
- 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
- The following inclusion criteria will be applied to parents (on behalf of their children):
- Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
- Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities
- Parent of patient at participating clinical site/child received non-urgent care visit during study period
- Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment.
Who cannot join
- °Parent under age of 18
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: CONFIDENCE: A Pilot Randomized Control Trial With Waitlist Condition to Test a Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.
Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.
- Conditions
- COVID-19 Vaccination
- Being tested
- CONFIDENCE
- Keywords
- Vaccination hesitancy
- Medical subject headings
- Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONFIDENCEBehavioural
This clinic-based, multicomponent intervention consists of 3 parts:
- Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents
- Parent-facing educational materials about COVID-19 vaccination
- Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Not described Receives: Behavioral: CONFIDENCE |
| Waitlist Condition | Active comparator | Clinics in this condition will receive the intervention approximately 12 months after the intervention condition. Receives: Behavioral: CONFIDENCE |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccine intention
Parent exit survey in clinics: Parents will report their intention to vaccinate their children for COVID-19. See survey question below:
"Did you decide to vaccinate your child against COVID-19 today? Yes/No"
Measured: Data collection will occur in the four weeks following implementation
Secondary outcomes (9)
Feasibility: Recruitment
Completion of the parent exit surveys will be documented and used to calculate the percentage of eligible parents (those who received a form) who completed the survey.
Measured: End of study; approximately 15 months
Feasibility: Data Completeness
Data completeness/missing data for all participant-level measures from the parent exit survey at the item-level will be examined. An exploratory analysis will be conducted to further decipher the quality of COVID-19 vaccination data in electronic medical records to determine its potential utility in a future trial.
Measured: End of study; approximately 15 months
Feasibility: Randomization
Recruitment, data completion and participant characteristics will be compared across the two study conditions to determine if differences emerge.
Measured: End of study; approximately 15 months
Acceptability: Parents
Perceived acceptability will be assessed via the survey question "How satisfied were you with the conversations about COVID-19 vaccination for your child at your visit today", which will have a 3-point Likert response scale, ranging from not at all to very satisfied.
Measured: Four to eight weeks post implementation
Perceived appropriateness: Parents
Perceived appropriateness will be assessed via the survey question "How appropriate were the conversations about COVID-19 vaccination for your child at your visit today?"
Measured: Four to eight weeks post implementation
Implementation Fidelity
Implementation fidelity will be assessed by three questions that ask about provider's behavior regarding the intervention: "Did you and the provider discuss COVID-19 vaccination for your child today?"; "Did the provider share their own COVID-19 experience with you?"; and "Did the doctor give you any materials about the COVID-19 vaccination today?".
Measured: Four to eight weeks post implementation
Acceptability: Providers and clinic staff
Will be assessed qualitatively through semi-structured interviews using questions like "How satisfied were you with intervention activities?"
Measured: Four to eight weeks post implementation
Perceived Appropriateness: Providers and clinic staff
Will be assessed qualitatively through semi-structured interviews using questions like "How relevant were intervention components and how compatible was the intervention with values and the workflow of the practice?"
Measured: Four to eight weeks post implementation
Perceived feasibility: Providers and clinic staff
Will be assessed qualitative through semi-structured interviews using questions like "What is the likelihood of sustaining the implementation of the intervention component in practice after the research study concludes."
Measured: Four to eight weeks post implementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start27 Mar 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 VaccinationStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators will be using a cluster, randomized control trial design, in which clinics are assigned to either the intervention or control group. Clinics in the control group or "waitlist" condition, will receive the intervention approximately 12 months later.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 667 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Baystate Health
- Responsible party
- Principal investigator, Stephenie Lemon, University of Massachusetts, Worcester
- Investigators
- Stephenie C Lemon, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722652
- Sponsor's protocol ID
- STUDY00000728
- Acronym
- CONFIDENCE
- Status last verified
- Jan 2025
- First submitted
- 8 Feb 2023
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified individual-level dataset will be made available to researchers who make a reasonable request to the principal investigator. Data will be made available upon publication of the primary outcomes manuscript.
Publications
Ryan GW, Goulding M, Borg A, Minkah P, Beeler A, Rosal MC, Lemon SC. Development and Beta-Testing of the CONFIDENCE Intervention to Increase Pediatric COVID-19 Vaccination. J Pediatr Health Care. 2023 May-Jun;37(3):244-252. doi: 10.1016/j.pedhc.2022.11.002. Epub 2022 Nov 17.
PubMed 36470798
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONFIDENCE: A Pilot Randomized Control Trial With Waitlist Condition to Test a Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
- ClinicalTrials.gov ID
- NCT05722652
- Acronym / sponsor ID
- CONFIDENCE / STUDY00000728
- Conditions
- COVID-19 Vaccination
- Keywords
- Vaccination hesitancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 667 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Baystate Health
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 10 Feb 2023 (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.
The goal of this study is to refine and test CONFIDENCE, a multi-component clinic-based intervention in pediatric or family practice clinical settings. Using a randomized control trial design, the investigators will assess preliminary effectiveness of the intervention to increase COVID-19 vaccine intention among parents of under-vaccinated children ages 5 to 17.
Participating clinics will receive a brief intervention consisting of: (1) webinar training focused on communication with vaccine-hesitant parents, (2) parent-facing educational materials about COVID-19 vaccination, (3) support to create a personalized, poster campaign featuring providers. Clinics in the control condition will receive the intervention approximately 12 months after the clinics in the intervention condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The investigators will be using a cluster, randomized control trial design, in which clinics are assigned to either the intervention or control group. Clinics in the control group or "waitlist" condition, will receive the intervention approximately 12 months later.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: CONFIDENCE |
| Waitlist Condition | Active comparator | Behavioral: CONFIDENCEClinics in this condition will receive the intervention approximately 12 months after the intervention condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The following inclusion criteria will be applied to parents (on behalf of their children):
- Parent/guardian (referred to as parents in this proposal) of child between ages 5 and 17
- Able to read and write in English, Spanish, Portuguese or Vietnamese, which are the predominant languages in the target communities
- Parent of patient at participating clinical site/child received non-urgent care visit during study period
- Child not up-to-date for COVID-19 per current CDC guidelines at the time of enrollment.
Key exclusion criteria (1 listed)
- °Parent under age of 18
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 |
|---|---|---|
| CONFIDENCEThis clinic-based, multicomponent intervention consists of 3 parts: 1. Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents 2. Parent-facing educational materials about COVID-19 vaccination 3. Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination | Behavioural | Intervention Condition, Waitlist Condition |
Primary outcome
COVID-19 vaccine intention
Time frame: Data collection will occur in the four weeks following implementation
Parent exit survey in clinics: Parents will report their intention to vaccinate their children for COVID-19. See survey question below: "Did you decide to vaccinate your child against COVID-19 today? Yes/No"
9 secondary outcomes
Feasibility: Recruitment
Time frame: End of study; approximately 15 months
Feasibility: Data Completeness
Time frame: End of study; approximately 15 months
Feasibility: Randomization
Time frame: End of study; approximately 15 months
Acceptability: Parents
Time frame: Four to eight weeks post implementation
Perceived appropriateness: Parents
Time frame: Four to eight weeks post implementation
Implementation Fidelity
Time frame: Four to eight weeks post implementation
Acceptability: Providers and clinic staff
Time frame: Four to eight weeks post implementation
Perceived Appropriateness: Providers and clinic staff
Time frame: Four to eight weeks post implementation
Perceived feasibility: Providers and clinic staff
Time frame: Four to eight weeks post implementation
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 14 Jan 2025.
- Background: PubMed 36470798Ryan GW, Goulding M, Borg A, Minkah P, Beeler A, Rosal MC, Lemon SC. Development and Beta-Testing of the CONFIDENCE Intervention to Increase Pediatric COVID-19 Vaccination. J Pediatr Health Care. 2023 May-Jun;37(3):244-252. doi: 10.1016/j.pedhc.2022.11.002. Epub 2022 Nov 17.
- Individual participant dataSharing planned: Yes. A de-identified individual-level dataset will be made available to researchers who make a reasonable request to the principal investigator. Data will be made available upon publication of the primary outcomes manuscript.
Related trials for COVID-19 Vaccination
Active, not recruiting
Working Towards Empowered Community-driven Approaches to Increase Vaccination and Preventive Care Engagement
COVID-19
Active, not recruitingObservational study
SCIVAX: Biomarkers of Immune Dysfunction and Vaccine Responsiveness in Chronic SCI
Spinal Cord Injuries, Traumatic Spinal Cord Injury
RecruitingObservational study
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis, Myocarditis Acute
Active, not recruitingObservational study
Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
Active, not recruitingObservational study
Korean Post Marketing Surveillance for Comirnaty Injection (Bretovameran)
COVID-19 Vaccination
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.
Stephenie C Lemon, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONFIDENCE in people with COVID-19 Vaccination, run by University of Massachusetts, Worcester 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 5 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 14 Jan 2025. 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?
COVID-19 vaccine intention (time frame: Data collection will occur in the four weeks following implementation). 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 NCT05722652, which also lists 1 linked publication.
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 14 Jan 2025.