StressNCT05298865
Parental Health Decision-making for Children During the COVID-19 Pandemic
A study testing Positive imagination stimulation and Neutral recall message in people with Stress and Coping Skills, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Background: As major decision-maker for children's wellbeing, parents play a vital role in decisiding on a wide range of health-related issues including vaccination. Such decision-making process will be complicated by a great amount of psychosocial stressors emerging from the current pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Coping Skills
- What is being tested?
- Positive imagination stimulation and Neutral recall message
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 843 participants
- Where
- 1 siteHong Kong
- Study dates
- 28 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Has at least one child aged below 12 years old;
- Hong Kong resident；
- Able to communicate in Cantonese, Mandarin or English;
- Capable of completing online questionnaire via WhatsApp.
Who cannot join
- Subjects with cognitive and linguistic difficulties prohibiting completing the interview will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Stress-induced Decision-making Bias in Parents for Promoting COVID-19 Vaccination Among Hong Kong Children: a Survey-based Experiment
Background: As major decision-maker for children's wellbeing, parents play a vital role in decisiding on a wide range of health-related issues including vaccination. Such decision-making process will be complicated by a great amount of psychosocial stressors emerging from the current pandemic. Stress can lead to various decision-making biases for children vaccination and subsequently lead to low vaccination intention amongst parents, which may hinder the progress for reaching herd immunity and end the COVID-19 pandemic. Effective risk communication intervention thus is in urgent need to address stress-induced decision-making biases for an upcoming COVID-19 vaccine for young children.
Aims: This study will investigate the interrelationships among parental perceived stress, and interpretive bias toward negative vaccine-related stimuli and and vaccination intention. In addition, this study will also conduct a survey experiment to develop positive affect-based messages and test its effect on correcting stress-induced biases in vaccination decision making among parents with high mental stress level.
Read more
Design and subjects: We aim to recruit parents aged 18 years or above with at least one child in our study. Participants will be recruited from our previous study through WhatsApp. Participants will be invited to read a list of vaccine-related news headlines with a mixture of positive and negative sentiments first. Then they will be asked to complete a series of assessment on their vaccination decision-making and intention. In the next phase, a survey-based experiment will be embedded in the online questionnaire to test the effect of risk communication interventions. Intervention messages will be designed based on previous qualitative study and literatures on positive psychology to simulate parents' positive mental images of COVID-19 vaccination consequences by using positive-affect visual stimuli.
Main outcome measures and analysis: Participants will be invited to complete a series of assessments through online questionnaire to assess their mental stress level, negative interpretive bias on processing ambiguous vaccine information and behavioural intention for vaccinating children.
Paired t-test will be used to determine negative interpretive bias between high-stress vs. low-stress parents. Structural equation modelling (SEM) will be performed to test the relationships among parental mental stress level, affect-driven decision-making constructs and vaccination intention for children. For the survey-based experiment, the effect of positive-affect messages intervention on tendency of correcting decision-making biases and COVID-19 vaccine uptake for children will be evaluated using logistic regression model with perceived stress level and intervention as the main between-group factors.
- Conditions
- Stress, Coping Skills
- Being tested
- Positive imagination stimulation, Neutral recall message
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive imagination stimulationBehavioural
The intervention messages aim to generate participants' positive mental image toward their life and also to relieve parental stress by shifting their attention to positive life events. The positive affect cues will be developed based on qualitative interviews with 30 parents from our previous study during pandemic and also extended literatures on positive psychology. Our previous qualitative interview aimed to understand parental concerns on flu and COVID-19 vaccination, parental life stressors throughout the pandemic were also explored. The positive cues will be discussed and evaluated by the research team with an aim to cover major positive life events that are personal relevant to parents, including positive social support (friendship), positive family support (family gathering), qualified time spent with children (here we will also embed a gratitude practice to elicit strong positive feelings), and cultivate positive self by imagining achieving personal goals in the future.
Neutral recall messageBehavioural
The control message aims to equate time and attention as in the intervention group. Therefore, a recall task will be assigned to participants. Brief texts will be provided to guide participants to memorize their life senarios but not to induce emotions. Messages include the following: recall the breakfast and lunch you had yesterday; recall the clothes and shoes you wore yesterday; recall the kitchen in your home; recall one of the chairs in your home; recall the routes to the nearest supermarket and subway of your house.
| Study group | Role | What they receive |
|---|---|---|
| Neutral recall message | Placebo comparator | Control group will receive a set of messages guiding them to recall neutral life senarios/objects. The messages will contain eight brief paragraphs of neutral text and icon-based pictures to guide participants to recall their life senarios. The text message will include yesterday's meals, yesterday's wearing, home environment and nearby locations. This control condition equated attention and time on task but expect not to induce any emotions in participants. Receives: Behavioral: Neutral recall message |
| Positive imagination stimulation | Experimental | Positive-affect-priming group (PA) will receive a set of messages guiding participants to imagine positive future life senarios. Prior receiving the PA messages, a brief instruction will also be provided to guide participants to imagine concrete and personal images while browsing the following messages. The PA messages will contain eight pictures representing the life senarios and accompanying with short text to guide participants' imagination. Each senario will contain two pictures, one is used to familiarized participants with the context that they are going to imagine (i.e. imagine one of your best friends); the second one provides richer information to stimulate participants' concrete imagination (i.e. imagine you share a good news with your friend). These intervention messsages aim to intentionally manipulate participants' feelings arousal and mental representation for positive future life. Receives: Behavioral: Positive imagination stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative interpretive bias
The negativity processing bias will be assessed by participants' subjective rating on a set of ambiguous news regarding the current pandemic. All the news will be adapted from real local news to simulate a natural news environment for participants. All the news will contain two parts, the former part will be risk-focused (more negative) while the latter part will be solution-focused (more positive). After reading 3 pieces of news, participants will be asked to rate how positive or negative of the news and how they feel about the news (valence and affective respond will be rated on a 7-point slider, -3 indicates very negative/pessimistic; 0 indicates neutral; 3 indicates very positive/optimistic). An additional question will be asked to assess participants' perceived self-efficacy after reading the news (scale 1-5, 1 indicates No confidence at all; 5 indicates Very confident). The valence, affect and self-efficacy scores for the 3 news will be summed into a single index for analysis
Measured: Immediately after they complete the task with priming manipulation
Secondary outcomes (2)
Parental vaccine-hesitant attitudes after two weeks.
The parental vaccine-hesitant attitudes will be assessed using a 5-point Likert scale (1-5). Five statements are shown and the participants will be asked to rate the degree to which they agree or disagree with the statements. With 1 indicating Strongly disagree and 5 indicating Strongly agree.
Measured: Two weeks after priming manipulation
Parental Mental Health Status
The parental mental health status will be assessed by Patient Health Questionnaire-4 (PHQ-4) two weeks after priming manipulation. The questionnaire contains 4 items describing different mental state (e.g. Feeling nervous, anxious or on edge) and the participants will be asked to rate how close these 4 items match their own situation in the past two weeks on a 4-point Likert scale (from 0-3). With 0 indicating Not at all and 3 indicating Nearly every day.
Measured: Two weeks after priming manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start28 Apr 2022
- Primary completion31 Dec 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiuyan Liao, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298865
- Sponsor's protocol ID
- 20220113pavdm
- Status last verified
- May 2023
- First submitted
- 23 Mar 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Stress-induced Decision-making Bias in Parents for Promoting COVID-19 Vaccination Among Hong Kong Children: a Survey-based Experiment
- ClinicalTrials.gov ID
- NCT05298865
- Acronym / sponsor ID
- 20220113pavdm
- Conditions
- Stress, Coping Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 28 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 28 Mar 2022 (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.
Background: As major decision-maker for children's wellbeing, parents play a vital role in decisiding on a wide range of health-related issues including vaccination. Such decision-making process will be complicated by a great amount of psychosocial stressors emerging from the current pandemic. Stress can lead to various decision-making biases for children vaccination and subsequently lead to low vaccination intention amongst parents, which may hinder the progress for reaching herd immunity and end the COVID-19 pandemic. Effective risk communication intervention thus is in urgent need to address stress-induced decision-making biases for an upcoming COVID-19 vaccine for young children.
Aims: This study will investigate the interrelationships among parental perceived stress, and interpretive bias toward negative vaccine-related stimuli and and vaccination intention. In addition, this study will also conduct a survey experiment to develop positive affect-based messages and test its effect on correcting stress-induced biases in vaccination decision making among parents with high mental stress level.
Design and subjects: We aim to recruit parents aged 18 years or above with at least one child in our study. Participants will be recruited from our previous study through WhatsApp. Participants will be invited to read a list of vaccine-related news headlines with a mixture of positive and negative sentiments first. Then they will be asked to complete a series of assessment on their vaccination decision-making and intention. In the next phase, a survey-based experiment will be embedded in the online questionnaire to test the effect of risk communication interventions. Intervention messages will be designed based on previous qualitative study and literatures on positive psychology to simulate parents' positive mental images of COVID-19 vaccination consequences by using positive-affect visual stimuli.
Main outcome measures and analysis: Participants will be invited to complete a series of assessments through online questionnaire to assess their mental stress level, negative interpretive bias on processing ambiguous vaccine information and behavioural intention for vaccinating children.
Paired t-test will be used to determine negative interpretive bias between high-stress vs. low-stress parents. Structural equation modelling (SEM) will be performed to test the relationships among parental mental stress level, affect-driven decision-making constructs and vaccination intention for children. For the survey-based experiment, the effect of positive-affect messages intervention on tendency of correcting decision-making biases and COVID-19 vaccine uptake for children will be evaluated using logistic regression model with perceived stress level and intervention as the main between-group factors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neutral recall message | Placebo comparator | Behavioral: Neutral recall messageControl group will receive a set of messages guiding them to recall neutral life senarios/objects. The messages will contain eight brief paragraphs of neutral text and icon-based pictures to guide participants to recall their life senarios. The text message will include yesterday's meals, yesterday's wearing, home environment and nearby locations. This control condition equated attention and time on task but expect not to induce any emotions in participants. |
| Positive imagination stimulation | Experimental | Behavioral: Positive imagination stimulationPositive-affect-priming group (PA) will receive a set of messages guiding participants to imagine positive future life senarios. Prior receiving the PA messages, a brief instruction will also be provided to guide participants to imagine concrete and personal images while browsing the following messages. The PA messages will contain eight pictures representing the life senarios and accompanying with short text to guide participants' imagination. Each senario will contain two pictures, one is used to familiarized participants with the context that they are going to imagine (i.e. imagine one of your best friends); the second one provides richer information to stimulate participants' concrete imagination (i.e. imagine you share a good news with your friend). These intervention messsages aim to intentionally manipulate participants' feelings arousal and mental representation for positive future life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has at least one child aged below 12 years old;
- Hong Kong resident；
- Able to communicate in Cantonese, Mandarin or English;
- Capable of completing online questionnaire via WhatsApp.
Key exclusion criteria (1 listed)
- Subjects with cognitive and linguistic difficulties prohibiting completing the interview will be excluded.
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 |
|---|---|---|
| Positive imagination stimulationThe intervention messages aim to generate participants' positive mental image toward their life and also to relieve parental stress by shifting their attention to positive life events. The positive affect cues will be developed based on qualitative interviews with 30 parents from our previous study during pandemic and also extended literatures on positive psychology. Our previous qualitative interview aimed to understand parental concerns on flu and COVID-19 vaccination, parental life stressors throughout the pandemic were also explored. The positive cues will be discussed and evaluated by the research team with an aim to cover major positive life events that are personal relevant to parents, including positive social support (friendship), positive family support (family gathering), qualified time spent with children (here we will also embed a gratitude practice to elicit strong positive feelings), and cultivate positive self by imagining achieving personal goals in the future. | Behavioural | Positive imagination stimulation |
| Neutral recall messageThe control message aims to equate time and attention as in the intervention group. Therefore, a recall task will be assigned to participants. Brief texts will be provided to guide participants to memorize their life senarios but not to induce emotions. Messages include the following: recall the breakfast and lunch you had yesterday; recall the clothes and shoes you wore yesterday; recall the kitchen in your home; recall one of the chairs in your home; recall the routes to the nearest supermarket and subway of your house. | Behavioural | Neutral recall message |
Primary outcome
Negative interpretive bias
Time frame: Immediately after they complete the task with priming manipulation
The negativity processing bias will be assessed by participants' subjective rating on a set of ambiguous news regarding the current pandemic. All the news will be adapted from real local news to simulate a natural news environment for participants. All the news will contain two parts, the former part will be risk-focused (more negative) while the latter part will be solution-focused (more positive). After reading 3 pieces of news, participants will be asked to rate how positive or negative of the news and how they feel about the news (valence and affective respond will be rated on a 7-point slider, -3 indicates very negative/pessimistic; 0 indicates neutral; 3 indicates very positive/optimistic). An additional question will be asked to assess participants' perceived self-efficacy after reading the news (scale 1-5, 1 indicates No confidence at all; 5 indicates Very confident). The valence, affect and self-efficacy scores for the 3 news will be summed into a single index for analysis
2 secondary outcomes
Parental vaccine-hesitant attitudes after two weeks.
Time frame: Two weeks after priming manipulation
Parental Mental Health Status
Time frame: Two weeks after priming manipulation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive imagination stimulation and Neutral recall message in people with Stress and Coping Skills, run by The University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative interpretive bias (time frame: Immediately after they complete the task with priming manipulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 May 2023.