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NCT Number: NCT07510230

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

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.

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Key information

Conditions

Anxiety Anxiety Disorders Behavior Health Behavior Immunisation Anxiety Related Reaction Mental Disorders Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Promotion Vaccination Refusal Vaccine Decision Making

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention

Behavioral

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 usual

Behavioral

Existing information provided by primary health care centre around childhood vaccination.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dung E Jidong, PhD

CONTACT

[email protected]

Tarela J Ike, PhD

CONTACT

[email protected]

0164234231

Sponsors and collaborators

Lead sponsor

Teesside University

Other

Collaborators

  • Jos University Teaching Hospital
  • University of Manchester

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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