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

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: Not yet recruiting
• Conditions: Anxiety; Vaccination Hesitancy; Vaccination Promotion; Immunisation Anxiety Related Reaction; Vaccine Decision Making
• Intervention / Treatment: Behavioral: ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention; Behavioral: Intervention as usual

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tarela J Ike, PhD; Phone Number: 0164234231; Email: T.ike@tees.ac.uk
• Study Contact Backup: Name: Dung E Jidong, PhD; Email: Dung.jidong@manchester.ac.uk

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Service Satisfaction Scale	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

Outcome Measure	Measure Description	Time Frame
Oslo Social Support Scale (OSSS-3)	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)	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	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	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	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	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	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

• Sponsor: Teesside University
• Collaborators: University of Manchester; Jos University Teaching Hospital

Publications and helpful links

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

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): February 8, 2027
• Study Completion (Estimated): February 8, 2027

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 3, 2026

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Vaccine Hesitancy; Vaccine Decision Making; Vaccination Promotion; Chilhood Vaccination Uptake
• Additional Relevant MeSH Terms: Mental Disorders; Behavior; Treatment Adherence and Compliance; Health Behavior; Treatment Refusal; Vaccination Refusal; Anxiety Disorders; Vaccination Hesitancy; Investigative Techniques; Methods
• Other Study ID 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