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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: COVID-19 Vaccination

Treatments: Behavioral: CONFIDENCE

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05722652

STUDY00000728

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Intervention Condition

Experimental group

Treatment:

Behavioral: CONFIDENCE

Waitlist Condition

Active Comparator group

Description:

Clinics in this condition will receive the intervention approximately 12 months after the intervention condition.

Treatment:

Behavioral: CONFIDENCE