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

April 14, 2023 updated by: Duke University
The purpose of this study is to develop and evaluate a tool designed to help parents make decisions about childhood vaccines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Childhood vaccination decision support tool
Participants receive childhood vaccination decision support tool
Other: Childhood vaccination decision support tool
Participants receive childhood vaccination decision support tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
Time Frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
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)
Change in Acceptability of Childhood Vaccinations
Time Frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institutes of Health (NIH)
National Center for Advancing Translational Sciences (NCATS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2020

Primary Completion (Actual)

March 24, 2022

Study Completion (Actual)

March 24, 2022

Study Registration Dates

First Submitted

July 24, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pro00101904
  • 1KL2TR002554 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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