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CompletedNCT04450940Updated Jun 30, 2020

Impact of PACV Administration on Vaccine Hesitancy

An interventional study of PACV survey and Placebo survey in Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns, sponsored by Baylor College of Medicine. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 6 years 8 months after the study started (first participant enrolled Oct 2013, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
1,705
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Our objective is to assess the impact of administering the PACV to parents of newborns. We also sought to assess the prevalence of vaccine hesitancy among parents of newborns in Houston, TX and to characterize the demographics of vaccine-hesitant parents.

Read the detailed description

Despite overwhelming scientific evidence demonstrating the safety and effectiveness of vaccines, parental immunization concerns continue to increase. Compared to parents who refuse all vaccines, vaccine-hesitant parents (VHP), defined as parents who are ambivalent towards vaccines, are of particular interest because they tend to be more amenable to vaccination. VHPs tend to be part of a larger group of parents with moderate vaccine concerns who seek additional information from their healthcare provider before deciding whether or not to immunize. These parents will sometimes immunize after education and reassurance from their provider. Alternatively, they may choose to delay or refuse certain vaccines. It is important to identify VHPs early in the medical relationship to provide effective communication and appropriate education regarding vaccine concerns in order to ensure maximum immunization coverage for the children of these parents.

The Parent Attitudes about Childhood Vaccines (PACV) survey was previously developed to identify VHPs. In a follow up study, the survey was validated and found to be a reliable instrument in identifying VHPs. The PACV survey differs from other survey instruments in that it seeks to specifically identify VHPs. Moreover, the survey was found to be a reliable predictor of immunization status with higher total PACV scores associated with under-immunization.5 It is unknown if administering the PACV survey can have a negative impact on parental immunization beliefs or if the PACV survey can elicit vaccine concerns that otherwise would not have been present at that point in time.

Study enrollment will occur among parents/guardians of children who are scheduled at a Texas Children's Pediatric practice for an 2-week well child visit. Parents/guardians of children will receive an enrollment packet containing a self-screening form, cover letter, and survey from the practice staff at their appointment check-in. Parents will be randomized to receive 1 of 2 surveys - either the PACV or a placebo survey about general childhood health topics. Upon receipt of the enrollment packet, the parent/guardian will be asked to complete a self-screening form to determine if they meet eligibility criteria. If the parent/guardian does not meet eligibility criteria the self-screening form will direct them to return the enrollment packet unopened to the front desk staff. Parents/guardians of children meeting eligibility criteria will be directed to open the enrollment packet and complete the survey. The PACV survey will then be administered to all subjects six months following the initial survey administration.

Prevalence of vaccine hesitancy will be calculated for each group (initial PACV or placebo survey) separately and then for both groups combined. PACV scores calculated from the second administration at 6 months will be compared across groups to evaluate if administration of the PACV increases vaccine hesitancy.

Inclusion criteria:

  1. Person must self-identify as English-speaking.
  2. Parent of a child less than 3 months of age.
  3. Parent must be 18 years of age or older.
  4. Parent of a child seeking routine, well-child care at a selected TCP practice site.

Exclusion criteria:

  1. Person does not self-identify as English-speaking.
  2. Parent of child greater than 3 months of age.
  3. Parent is less than 18 years of age.
  4. Parent of child not seeking routine, well-child care at a selected TCP practice site.
02

Conditions studied

  • Evaluating Impact of PACV on Vaccine Hesitancy Among Parents of Newborns

Keywords

  • Parental Attitudes about Childhood Vaccines
  • vaccine hesitancy
03

In context

Lead sponsor

Baylor College of Medicine is the lead sponsor of 734 studies on the registry; 110 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 44 (53%) 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
Yes

Inclusion criteria

  1. Person must self-identify as English-speaking.
  2. Parent of a child less than 3 months of age.
  3. Parent must be 18 years of age or older.
  4. Parent of a child seeking routine, well-child care at a selected TCP practice site.

Exclusion criteria

Exclusion Criteria:

  1. Person does not self-identify as English-speaking.
  2. Parent of child greater than 3 months of age.
  3. Parent is less than 18 years of age.
  4. Parent of child not seeking routine, well-child care at a selected TCP practice site.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
1,705 participants (actual)

Study arms

  • Experimental
    PACV

    The PACV arm received the PACV survey at baseline in order to assess the impact of administration on vaccine hesitancy. All participants received the PACV at 6-month follow up.

    Behavioral: PACV survey

  • Sham comparator
    Placebo

    The placebo arm received a placebo survey on general childhood health topics at baseline. All participants received the PACV at 6-month follow up.

    Behavioral: Placebo survey

Interventions

  • BehavioralPACV survey
  • BehavioralPlacebo survey
06

What researchers measure

Primary outcomes

  1. Impact of PACV administration on vaccine hesitancy

    We assessed the change in the proportion of vaccine-hesitant parents between baseline and 6-month follow up

    Time frame: 6 months

Secondary outcomes

  1. Prevalence of vaccine hesitancy

    We assessed the proportion of vaccine-hesitant parents

    Time frame: 6 months

  2. Summarize characteristics of vaccine-hesitant parents

    We sought to summarize the demographic characteristics of vaccine-hesitant parents and examine associations between vaccine hesitancy and participant characteristics

    Time frame: 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04450940
Lead sponsor
Baylor College of Medicine
Collaborators
Seattle Children's Hospital
Responsible party
Julie Boom (Medical Director, Immunization Project; Associate Professor of Pediatrics, Baylor College of Medicine) — Principal investigator
First posted
Jun 30, 2020
Start date
Oct 2013
Primary completion
Jun 2016
Completion
Jun 2016
Last update
Jun 30, 2020

Oversight

Data monitoring committee
No
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 Jun 2020. You cannot join it, but the record below documents what was studied.

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