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

Purpose

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.

Condition

  • COVID-19 Vaccination

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Prevention
Masking
Single (Participant)
Masking Description
Clinics will know if they are assigned to the intervention or control condition. However, individual participants (parents of children ages 5 to 17) will not know if their clinic is in the intervention or control condition.

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

UMass Chan Medical School
Worcester, Massachusetts 01605
Contact:
Grace W Ryan, PhD

More Details

NCT ID
NCT05722652
Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Stephenie C Lemon, PhD
508-856-4098
stephenie.lemon@umassmed.edu