ClinicalTrials.gg
CompletedNCT04496453ADEPTUpdated Apr 18, 2023Results posted

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

An interventional study of Childhood vaccination decision support tool in Vaccine Refusal, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Vaccine Refusal

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Keywords

  • childhood vaccines
  • vaccine hesitancy
  • vaccination
03

In context

Vaccination Hesitancy

42 studies on the registry are indexed under Vaccination Hesitancy; 7 are open to participants now.

This study's enrollment of 17 is below the median of 390 across 39 interventional studies indexed under Vaccination Hesitancy.

Browse Vaccination Hesitancy studies →

Lead sponsor

Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Unable to understand the study objectives, procedures, risks, and benefits
  • Unable to consent for themselves
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Childhood vaccination decision support tool

    Participants receive childhood vaccination decision support tool

    Other: Childhood vaccination decision support tool

Interventions

  • OtherChildhood vaccination decision support tool

    Participants receive childhood vaccination decision support tool

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

  2. Change in Acceptability of Childhood Vaccinations

    Time frame: pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

07

Results

Posted Apr 18, 2023

Participant flow

Participant flow — Overall Study
MilestoneChildhood Vaccination Decision Support Tool
Started17
Completed11
Not completed6
Withdrew: Lost to follow-up6

Outcome measures

PrimaryChange 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.

Time frame:
pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)
Reported as:
Mean · score on a scale
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire
score on a scaleChildhood Vaccination Decision Support Tool
Change in Knowledge Related to Childhood Vaccinations as Measured by Study Specific Questionnaire1.27 ± 1.68
PrimaryChange in Acceptability of Childhood Vaccinations
Time frame:
pre-survey (baseline) and post-survey (at completion of intervention, approximately 4-6 weeks after baseline)

No measurements were reported for this outcome.

Adverse events

Collected over Approximately 4-6 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Childhood Vaccination Decision Support Tool0/17 (0%)0/17 (0%)0/17 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Childhood Vaccination Decision Support Tool
Mean34.06 ± 7.33
Sex: Female, Male
Sex: Female, Male(Participants)Childhood Vaccination Decision Support Tool
Female17
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Childhood Vaccination Decision Support Tool
Hispanic or Latino0
Not Hispanic or Latino17
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Childhood Vaccination Decision Support Tool
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American8
White6
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Childhood Vaccination Decision Support Tool
United States17
08

Study locations

1 site
  • Duke University Health System
    Durham, North Carolina 27710, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 16, 2023
  • Informed consent form · Nov 10, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04496453
Lead sponsor
Duke University
Responsible party
Sponsor
First posted
Aug 3, 2020
Start date
Dec 14, 2020
Primary completion
Mar 24, 2022
Completion
Mar 24, 2022
Results posted
Apr 18, 2023
Last update
Apr 18, 2023

Study contacts

Lavanya Vasudevan, Ph.D.
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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