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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention Condition |
|
|
|
Active Comparator Waitlist Condition |
Clinics in this condition will receive the intervention approximately 12 months after the intervention condition. |
|
Recruiting Locations
UMass Chan Medical School
Worcester, Massachusetts 01605
Worcester, Massachusetts 01605
Contact:
Grace W Ryan, PhD
Grace W Ryan, PhD
More Details
- NCT ID
- NCT05722652
- Status
- Recruiting
- Sponsor
- University of Massachusetts, Worcester