Skip to main content
OpenTrials
Completed

NCT Number: NCT03934008

Motivational Interviewing and Vaccine Hesitancy in Children

This study will assess the effectiveness of a motivational interviewing-based tool in addressing vaccine hesitancy expressed by parents or caregivers of children.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaccine Hesitancy Behavior Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal

Age range

0 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rocking Horse Community Heath Center

Springfield, Ohio, 45505, United States

About this study

In order for vaccines to be effective and protect communities from diseases, a large majority of individuals need to be vaccinated to protect those who do not respond to the vaccine and those who cannot be vaccinated. While vaccine hesitancy has been noted as a growing problem among parents, there are few evidence-based strategies for providers to utilize to discuss vaccination with these parents. Therefore, there is a critical need to develop effective communication tools to increase parental confidence in vaccines. A tool based on the principles of motivational interviewing (a goal-oriented, collaborative counseling style) may be effective in addressing this need. Thus, the aim of this study is to determine the impact of a motivational interviewing-based (MI-based) tool on pediatric vaccination rates through assessment of changes in the percentage of patients achieving the goal of completion of all recommended doses in children 6 years of age and younger. Secondary aims include determining the impact of the motivational-interviewing based tool on parental health beliefs regarding vaccines and the impact of the training on provider knowledge and confidence in using motivational interviewing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

(primary outcome):

  • Patients 0-6 years of age
  • Seen in the Rocking Horse Community Center by a pediatric provider during the baseline or study period

Inclusion criteria

(secondary parental health belief outcomes):

  • Parents/caregivers (1) ≥18 years old
  • Read English
  • Have at least one child ≤6 years of age

Inclusion criteria

(secondary provider outcomes): All providers who interact with pediatric patients in the Rocking Horse Community Center who

  • Complete the training
  • Implement the MOTIVE tool in practice

Treatment and study plan

MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)

Other

The MOTIVE tool incorporates the principles of motivational interviewing (MI) and provides a flowchart approach in which parental health beliefs have a corresponding MI-based strategy to further explore and/or address the hesitancy. The tool was developed from interviews with pediatricians and pediatric pharmacists, a review of the literature focusing on vaccine health beliefs, and the Parent Attitudes about Childhood Vaccines (PACV) Survey Tool. The tool was reviewed by multiple providers and feedback was provided on its usability in clinical practice when interacting with vaccine-hesitant parents and/or caregivers. The tool was then modified based on this feedback. Pediatric providers will complete four educational sessions on vaccine hesitancy, MI, and the use of the MOTIVE tool in clinical practice prior implementation.

Primary outcomes

  1. The percentage of children 0-6 years of age receiving all recommended doses of the core vaccine series

    Time frame: Change from baseline at 12 months post intervention implementation

    The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive all doses of the core immunization series (HepB, DTaP, Hib, PCV13, IPV, MMR, VAR, Hep A) for the patient's age according to the Advisory Committee on Immunization Practices (ACIP) and Centers for Disease Control (CDC) Immunization Schedule during the intervention year compared to the same percentage in the control group over the previous year.

  2. The percentage of children 0-6 years of age receiving all recommended vaccines doses

    Time frame: Change from baseline at 12 months post intervention implementation

    The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive all doses (including rotavirus and influenza) of recommended vaccines according to the ACIP/CDC Immunization Schedule during the intervention year compared to the same percentage in the control group over the previous year.

  3. The percentage of children 0-6 years of age receiving appropriate influenza vaccination

    Time frame: Change from baseline at 12 months post intervention implementation

    The percentage of eligible patients presenting for care at Rocking Horse Community Center who receive appropriate influenza vaccination according to the ACIP/CDC Immunization Schedule during the intervention year compared to the percentage in the control group over the previous year.

  4. Number of deferred vaccine doses

    Time frame: Change from baseline at 12 months post intervention implementation

    Number of deferred vaccine doses per 100 patients during the intervention year compared to the number of deferred vaccine doses in the control group over the previous year.

Secondary outcomes

  1. Parental attitude towards vaccines (PACV total score)

    Time frame: Change from baseline at post-encounter assessment (within 24 hours of receiving MI-based intervention)

    The difference in Parental Attitudes about Childhood Vaccines (PACV) total score (range 0-100, with higher scores indicating greater hesitancy) in parents who have answered yes to items 3 and 4 in the pre-survey population compared to those who receive the MI-based intervention.

  2. Provider knowledge of utilizing motivational interviewing to address vaccine hesitancy

    Time frame: Change from baseline at 2 months after the provider training period is completed

    The change in the Knowledge subscale (5 items, range 0-5, with higher scores indicating greater knowledge) of the Motivational Interviewing Provider Scale.

  3. Provider confidence in utilizing motivational interviewing to address vaccine hesitancy

    Time frame: Change from baseline at 2 months after the provider training period is completed

    The change in the Confidence subscale (range 16-96, with higher scores indicating greater confidence) of the Motivational Interviewing Provider Scale.

Sponsors and collaborators

Lead sponsor

Cedarville University

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • Rocking Horse Community Health Center

Registry information

Official study title

An Observational Study to Analyze the Effectiveness of a Motivational Interviewing-based Decision Tool to Address Vaccination Hesitancy in Children

Acronym: MOTIVE

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 1, 2019
Registry last updated
Sep 9, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.