Parental Health Decision-making for Children During the COVID-19 Pandemic

Stress Clinical Trial

Official title:

Addressing Stress-induced Decision-making Bias in Parents for Promoting COVID-19 Vaccination Among Hong Kong Children: a Survey-based Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05298865
• Other study ID #: 20220113pavdm
• Status: Completed
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects with cognitive and linguistic difficulties prohibiting completing the interview will be excluded.

Related Conditions & MeSH terms

• Coping Skills
• Stress

Intervention

Behavioral:
• Positive imagination stimulation
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 message
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.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong School of Public Health	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Immediately after they complete the task with priming manipulation
Secondary	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.	Two weeks after priming manipulation
Secondary	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.	Two weeks after priming manipulation