Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study

March 29, 2026 updated by: Tarela Ike, Teesside University

Media Campaign Intervention to Increase Childhood Immunisation Vaccine Uptake, Access and Reduce Vaccine Hesitancy for Parents/Caregivers With Children: A Pilot Randomised Controlled Trial

Vaccine hesitancy-defined as delayed acceptance or refusal of vaccines despite availability-remains a significant barrier to childhood immunisation uptake in Nigeria, a country with high zero-dose unvaccinated children. Several factors limit vaccine uptake, including poor awareness, misinformation, fear, anxiety and a perceived sense of conspiracy. Yet, a gap exists to address this urgent problem. The proposed study seeks to pilot the feasibility and acceptability of a novel co-produced media campaign intervention called ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) with parent-caregivers who are not or partially up to date with their child's vaccination. The ASSURE intervention is designed to encourage vaccine uptake and access, reduce vaccine hesitancy whilst addressing vaccine-related anxiety. The ASSURE intervention is low-intensity, lasting approximately 3-5-minute designed to raise awareness of the need for vaccination uptake and its implications for children, including their development and well-being whist addressing vaccine related anxiety and fears. The proposed study is also to pilot and test the instrument to determine effectiveness and cost effectiveness including the mechanism on why the intervention might potentially work.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Parent or primary caregivers aged 18 years and above
  • Whose child(ren) are not or partially up-to-date with childhood immunisation vaccination
  • Able to provide full consent for their participation.
  • Able to speak the English Language.
  • Able to take part in the intervention and are available for the intervention assessment at baseline and end of intervention.

Exclusion Criteria:

  • Less than 18 years
  • Parent or Career whose child(ren) are up-to-date with childhood immunisation vaccination
  • Unable to consent.
  • Currently undergoing severe mental health treatment.
  • Unable to speak the English language .

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention
The media campaign intervention is a low-intensity intervention lasting 3-5 minutes.
Behavioral: ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention
The media intervention is a low-intensity intervention lasting 3-5 minutes. The intervention is designed to promote awareness on the risk of vaccine hesitancy, its implication on the child wellbeing and health outcomes, the benefits of vaccination and immunisation and avenues or mediums for accessing childhood immunisation. The media intervention will also address anxiety associated with childhood vaccination and avenues for support. The recorded message introduction will commence with a welcome address on the topic, and this is followed by the core message and a closing remark. The core message is composed of three key ambits: 1) emphasising what is meant by vaccine hesitancy, risk of non-childhood immunisation, including the benefit of vaccination (ii) the need to vaccinate and stop societal stigmatising behaviour (iii) Avenues for accessing childhood immunisation and vaccination.
Active Comparator: Control group
The control group will receive intervention as usual. This may be in the form of existing vaccination information provided in primary health care centres
Behavioral: Intervention as usual
Existing information provided by primary health care centre around childhood vaccination.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Service Satisfaction Scale
Time Frame: At the end of intervention (day 2)
A five item scale that can be used to assess and measure satisfaction, acceptability and quality of the intervention. Higher score denote positive outcomes and acceptability. Lower score denotes poor satisfaction and acceptability.
At the end of intervention (day 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oslo Social Support Scale (OSSS-3)
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
The scale is a 3-item self-reported measure designed for assessing and measuring the level of social support. The sum score ranges from 3 to 14, with high values representing strong levels and low values representing poor levels of social support as indicated as follows: a) 3-8 poor social support, b) 9-11 moderate social support, c) 12-14 strong social support.
Baseline (day 1) and at the end of intervention (day 2)
Generalised Anxiety Disorder (GAD-7)
Time Frame: Baseline (day 1) and at the end of intervention (day 2)]
The GAD-7 is a seven item scale for screening, measuring and assessing the severity of generalised anxiety disorder. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Baseline (day 1) and at the end of intervention (day 2)]
Oxford Vaccine Hesitancy Scale
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
A 13 item scale to assess vaccine hesitancy. All items are scored using a 5-point Likert scale ranging from disagree completely to agree completely. Higher scores reflect increasing hesitancy. Items 1, 2, 3 and 5 are reverse scored. The total score can range from 13 to 65.
Baseline (day 1) and at the end of intervention (day 2)
Vaccine Conspiracy Belief Scale
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
The scale is a 7-item questionnaire to measure the extent to which an individual endorses conspiracy theories about vaccines. It is also a 7-point scale that ranges from 'strongly disagree' (1) to 'strongly agree' (7). The scores for all 7 items will be scored and divide by 7 to compute the average score. A higher average score indicates a stronger tendency toward vaccine conspiracy beliefs.
Baseline (day 1) and at the end of intervention (day 2)
European Quality of Life Scale EQ-5D-5L
Time Frame: (day 1) and at the end of intervention (day 2)
The EQ-5D-5L is a 5 item scale designed to aid assessment of the generic quality of life. In the EQ-5D-5L, each dimension has five response levels: no problems (Level 1); slight (Level 2); moderate (Level 3); severe (Level 4); and extreme problems (Level 5). There are 3,125 possible health states defined by combining one level from each dimension, ranging from 11111 (full health) to 55555 (worst health).
(day 1) and at the end of intervention (day 2)
World Health Organization (WHO) Childhood Vaccine Hesitancy Scale
Time Frame: (day 1) and at the end of intervention (day 2)
It is 10-item scale that measures vaccine hesitancy (delay or refusal) in parents/caregivers. Each item is measured by a five-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree). A higher score indicate more hesitancy.
(day 1) and at the end of intervention (day 2)
Cultural and religious belief scale about attitude towards childhood vaccine hesitancy
Time Frame: Baseline (day 1) and at the end of intervention (day 2)
The scale is an 8-item Likert type scale that will be used to assess the impact of culture and religions belief in influencing attitude towards childhood vaccine hesitancy. Low scores (e.g. 0-10) indicate non vaccine hesitancy, however, higher scores (30-40) indicates high level of vaccine hesitancy.
Baseline (day 1) and at the end of intervention (day 2)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Teesside University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Manchester
Jos University Teaching Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Kazungu, J. S., & Adetifa, I. M. (2017). Crude childhood vaccination coverage in West Africa: trends and predictors of completeness. Wellcome Open Research, 2, 12.
  • Gulumbe, B. H., Danlami, M. B., Yusuf, A. B., Shehu, A., & Chidiebere, O. (2024). Vaccine hesitancy under the lens: Nigeria's struggle against the worst diphtheria outbreak in decades. Therapeutic Advances in Infectious Disease, 11, 20499361241242218.

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0000-0003-0516-0313I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.

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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