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Completed

NCT Number: NCT05722652

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.

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Key information

Conditions

COVID-19 Vaccination Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Chan Medical School

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CONFIDENCE

Behavioral

This clinic-based, multicomponent intervention consists of 3 parts:

  • Webinar training for clinicians and clinic staff about how to communicate with vaccine-hesitant parents
  • Parent-facing educational materials about COVID-19 vaccination
  • Support in creating a personalized poster campaign featuring providers and clinic staff sharing personal stories about COVID-19 vaccination

Primary outcomes

  1. 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"

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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?"

  6. 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?".

  7. 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?"

  8. 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?"

  9. 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."

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Baystate Health
  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: CONFIDENCE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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