A Multicomponent Clinic-based Intervention to Promote COVID-19 Vaccine Intention and Uptake Among Diverse Youth and Adolescents
- Conditions
- COVID-19 Vaccination
- Interventions
- Behavioral: CONFIDENCE
- Registration Number
- NCT05722652
- Lead Sponsor
- University of Massachusetts, Worcester
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 667
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Waitlist Condition CONFIDENCE Clinics in this condition will receive the intervention approximately 12 months after the intervention condition. Intervention Condition CONFIDENCE -
- Primary Outcome Measures
Name Time Method COVID-19 vaccine intention 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 Outcome Measures
Name Time Method Feasibility: Randomization 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.
Perceived feasibility: Providers and clinic staff 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."
Feasibility: Recruitment 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.
Implementation Fidelity 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?".
Acceptability: Providers and clinic staff Four to eight weeks post implementation Will be assessed qualitatively through semi-structured interviews using questions like "How satisfied were you with intervention activities?"
Perceived Appropriateness: Providers and clinic staff 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?"
Perceived appropriateness: Parents 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?"
Feasibility: Data Completeness 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.
Acceptability: Parents 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.
Trial Locations
- Locations (1)
UMass Chan Medical School
🇺🇸Worcester, Massachusetts, United States