An interventional study of ASSURed awareness campaign to encourage childhood vaccine uptakE (ASSURE) intervention and Intervention as usual in Anxiety, Vaccination Hesitancy and Vaccination Promotion, sponsored by Teesside University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Teesside University · Not applicable, Interventional, and Prevention
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.
121 studies on the registry are indexed under Vaccination Hesitancy; 14 are open to participants now.
This study's planned enrollment of 74 is below the median of 516 across 98 interventional studies indexed under Vaccination Hesitancy.
Browse Vaccination Hesitancy studies →Teesside University is the lead sponsor of 55 studies on the registry; 10 are open to participants now.
Compared within Vaccination Hesitancy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anxiety Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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
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.
Existing information provided by primary health care centre around childhood vaccination.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: (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.
Time frame: (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.
Time frame: Baseline (day 1) and at the end of intervention (day 2)
No study locations are listed for this record.
Plan to share: No — Data supporting this study cannot be made available due to the sensitive nature and ethical reasons on confidentiality.
Start is estimated for Apr 2026; primary completion for Feb 2027, 9 months later.
Of 82 non-industry interventional studies with no phase under Vaccination Hesitancy, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 14. This study's planned 9 months is above that.
Counting every sponsor, half of 83 studies reached it within 5 months; a quarter within 2 and three quarters within 14.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Teesside University