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

NCT05722652 | Completed

• 1 other identifier: STUDY00000728
• Study Type: interventional
• Target: 667
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Vaccination hesitancy

Outcome Measures

Primary Outcomes (1)

• 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"

  Data collection will occur in the four weeks following implementation

Secondary Outcomes (9)

• Feasibility: Recruitment

  End of study; approximately 15 months

• Feasibility: Data Completeness

  End of study; approximately 15 months

• Feasibility: Randomization

  End of study; approximately 15 months

• Acceptability: Parents

  Four to eight weeks post implementation

• Perceived appropriateness: Parents

  Four to eight weeks post implementation

Study Arms (2)

Intervention Condition

EXPERIMENTAL

Behavioral: CONFIDENCE

Waitlist Condition

ACTIVE COMPARATOR

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

Behavioral: CONFIDENCE

Interventions

CONFIDENCE BEHAVIORAL

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

Intervention Condition; Waitlist Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• °Parent under age of 18

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Merck Sharp & Dohme LLC: collaborator
• Baystate Health: collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

Related Publications (1)

• 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.

  PMID: 36470798 BACKGROUND

MeSH Terms

Conditions

Vaccination Hesitancy

Interventions

Confidence Intervals

Condition Hierarchy (Ancestors)

Vaccination Refusal; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Stephenie C Lemon, PhD

  University of Massachusetts Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of the Division of Preventive and Behavioral Medicine, Department of Population and Quantitative Health Sciences

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 10, 2023
• Study Start: March 27, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available will be available upon publication of the primary outcomes manuscript from this project.
• Access Criteria: Data will be made available upon reasonable request from researchers.

Locations

US (1)