AnxietyNCT07510230
Media Orientation to Improve Childhood Vaccine Uptake and Address Parent and Caregivers Vaccine-related Anxiety: A Pilot Study
A study testing ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention and Intervention as usual in people with Anxiety and Vaccination Hesitancy, run by Teesside University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Vaccination Hesitancy, Vaccination Promotion
- What is being tested?
- ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention and Intervention as usual
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2026to 8 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 .
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Dung E Jidong, PhD contact
About this study
Official title: 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.
- Conditions
- Anxiety, Vaccination Hesitancy, Vaccination Promotion, Vaccine Decision Making, Immunisation Anxiety Related Reaction
- Being tested
- ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention, Intervention as usual
- Keywords
- Anxiety, Vaccine Hesitancy, Chilhood Vaccination Uptake, Vaccine Decision Making, Vaccination Promotion
- Medical subject headings
- Anxiety Disorders, Vaccination Hesitancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) interventionBehavioural
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.
Intervention as usualBehavioural
Existing information provided by primary health care centre around childhood vaccination.
| Study group | Role | What they receive |
|---|---|---|
| ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention | Experimental | The media campaign intervention is a low-intensity intervention lasting 3-5 minutes. Receives: Behavioral: ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention |
| Control group | Active comparator | The control group will receive intervention as usual. This may be in the form of existing vaccination information provided in primary health care centres Receives: Behavioral: Intervention as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of intervention (day 2)
Secondary outcomes (7)
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.
Measured: 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.
Measured: Baseline (day 1) and at the end of intervention (day 2)
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.
Measured: 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.
Measured: 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).
Measured: (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.
Measured: (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.
Measured: Baseline (day 1) and at the end of intervention (day 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start20 Apr 2026 (estimated)
- Primary completion8 Feb 2027 (estimated)
- Study completion8 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Teesside University
- Sponsor type
- University, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Responsible party
- Principal investigator, Tarela Ike, Teesside University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510230
- Sponsor's protocol ID
- 0000-0003-0516-0313I
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Publications
Kazungu JS, Adetifa IMO. Crude childhood vaccination coverage in West Africa: Trends and predictors of completeness. Wellcome Open Res. 2017 Feb 15;2:12. doi: 10.12688/wellcomeopenres.10690.1.
PubMed 28459105Gulumbe BH, Danlami MB, Yusuf AB, Shehu A, Chidiebere O. Vaccine hesitancy under the lens: Nigeria's struggle against the worst diphtheria outbreak in decades. Ther Adv Infect Dis. 2024 Mar 27;11:20499361241242218. doi: 10.1177/20499361241242218. eCollection 2024 Jan-Dec.
PubMed 38550914
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Media Campaign Intervention to Increase Childhood Immunisation Vaccine Uptake, Access and Reduce Vaccine Hesitancy for Parents/Caregivers With Children: A Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07510230
- Acronym / sponsor ID
- 0000-0003-0516-0313I
- Conditions
- Anxiety, Vaccination Hesitancy, Vaccination Promotion, Vaccine Decision Making, Immunisation Anxiety Related Reaction
- Keywords
- Anxiety, Vaccine Hesitancy, Chilhood Vaccination Uptake, Vaccine Decision Making, Vaccination Promotion
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Teesside UniversityUniversity, hospital or other
- Collaborators
- Jos University Teaching Hospital, University of Manchester
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 8 Feb 2027 (estimated)
- Study completion
- 8 Feb 2027 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention | Experimental | Behavioral: ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) interventionThe media campaign intervention is a low-intensity intervention lasting 3-5 minutes. |
| Control group | Active comparator | Behavioral: Intervention as usualThe control group will receive intervention as usual. This may be in the form of existing vaccination information provided in primary health care centres |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) interventionThe 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. | Behavioural | ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention |
| Intervention as usualExisting information provided by primary health care centre around childhood vaccination. | Behavioural | Control group |
Primary outcome
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.
7 secondary outcomes
Generalised Anxiety Disorder (GAD-7)
Time frame: 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)
Oslo Social Support Scale (OSSS-3)
Time frame: 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)
European Quality of Life Scale EQ-5D-5L
Time frame: (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)
Cultural and religious belief scale about attitude towards childhood vaccine hesitancy
Time frame: Baseline (day 1) and at the end of intervention (day 2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 28459105Kazungu JS, Adetifa IMO. Crude childhood vaccination coverage in West Africa: Trends and predictors of completeness. Wellcome Open Res. 2017 Feb 15;2:12. doi: 10.12688/wellcomeopenres.10690.1.
- Background: PubMed 38550914Gulumbe BH, Danlami MB, Yusuf AB, Shehu A, Chidiebere O. Vaccine hesitancy under the lens: Nigeria's struggle against the worst diphtheria outbreak in decades. Ther Adv Infect Dis. 2024 Mar 27;11:20499361241242218. doi: 10.1177/20499361241242218. eCollection 2024 Jan-Dec.
- Individual participant dataSharing planned: No. Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dung E Jidong, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention and Intervention as usual in people with Anxiety and Vaccination Hesitancy, run by Teesside University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tarela J Ike, PhD (0164234231, T.ike@tees.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Service Satisfaction Scale (time frame: At the end of intervention (day 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.