A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents (CONFIDENCE)

January 13, 2025 updated by: Stephenie Lemon, University of Massachusetts, Worcester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

667

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • UMass Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Practice site inclusion criteria

  • Pediatric or family practice clinic that serves pediatric population (ages 5 to 17)
  • Affiliated with UMass Memorial Health Care and/or Baystate Health
  • Serve a patient population that is at least 30% racial/ethnic minority group members.

Inclusion Criteria for Parents:

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.

Exclusion Criteria for Parents:

°Parent under age of 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Condition
Behavioral: CONFIDENCE

This 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
Active Comparator: Waitlist Condition
Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.
Behavioral: CONFIDENCE

This 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Data collection will occur in the four weeks following implementation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability: Parents
Time Frame: Four to eight weeks post implementation
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.
Four to eight weeks post implementation
Perceived appropriateness: Parents
Time Frame: Four to eight weeks post implementation
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?"
Four to eight weeks post implementation
Acceptability: Providers and clinic staff
Time Frame: Four to eight weeks post implementation
Will be assessed qualitatively through semi-structured interviews using questions like "How satisfied were you with intervention activities?"
Four to eight weeks post implementation
Perceived Appropriateness: Providers and clinic staff
Time Frame: Four to eight weeks post implementation
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?"
Four to eight weeks post implementation
Perceived feasibility: Providers and clinic staff
Time Frame: Four to eight weeks post implementation
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."
Four to eight weeks post implementation
Feasibility: Recruitment
Time Frame: End of study; approximately 15 months
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.
End of study; approximately 15 months
Feasibility: Data Completeness
Time Frame: End of study; approximately 15 months
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.
End of study; approximately 15 months
Feasibility: Randomization
Time Frame: End of study; approximately 15 months
Recruitment, data completion and participant characteristics will be compared across the two study conditions to determine if differences emerge.
End of study; approximately 15 months
Implementation Fidelity
Time Frame: Four to eight weeks post implementation
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?".
Four to eight weeks post implementation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

Merck Sharp & Dohme LLC
Baystate Health

Investigators

  • Principal Investigator: Stephenie C Lemon, PhD, University of Massachusetts Chan Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Actual)

October 31, 2024

Study Completion (Actual)

October 31, 2024

Study Registration Dates

First Submitted

February 8, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000728

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available will be available upon publication of the primary outcomes manuscript from this project.

IPD Sharing Access Criteria

Data will be made available upon reasonable request from researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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