Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

Vaccine Refusal Clinical Trial

— ADEPT  

Official title:

Development and Testing of ADEPT: A Parent Decision Support for Childhood Vaccinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04496453
• Other study ID #: Pro00101904
• Secondary ID: 1KL2TR002554
• Status: Completed
• Phase: N/A
• Start date: December 14, 2020
• Est. completion date: March 24, 2022

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: March 24, 2022
• Est. primary completion date: March 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• At least 18 years of age

• Parent or primary caregiver of a child between the ages of 3-6 years who is receiving primary care at Duke.

• Fluent in English

Exclusion Criteria:

• Unable to understand the study objectives, procedures, risks, and benefits

• Unable to consent for themselves

Related Conditions & MeSH terms

• Vaccine Refusal

Intervention

Other:
• Childhood vaccination decision support tool
Participants receive childhood vaccination decision support tool

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire	Study specific questionnaire comprised of 10 True or False questions. Knowledge was measured on a score of 0-10, where a higher score indicates a greater level of knowledge. Outcome reports on the difference in the knowledge score measure pre- and post- exposure to intervention.	pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Primary	Change in Acceptability of Childhood Vaccinations		pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)