Design
A cluster randomized controlled trial with two-arms were implemented to assess the efficacy of behavior change in decisions on antibiotic use in relation to childhood infection.
Setting
For confidentiality, computer generated numbers were used as codes to recruit kindergartens and parents of kindergarteners aged under 7, as clusters, to the intervention and control groups.
Participants
The subjects were selected according to the inclusion criterion that they were parents of kindergarteners aged below 7. Kindergartens were selected from the same region to ensure that the demographics of the two groups were comparable. Randomization was implemented by putting the sealed codes for selection inside a paper bag. The sample was then drawn randomly by an individual who was not associated with the study for allocation concealment to prevent selection and confounding biases. The parents in the intervention group were asked to join an education program on antibiotic usage and a peer support group, whereas those in the control group were only given information leaflets on antibiotics from the Centre for Health Protection.
Procedure
The intervention program consisted of two weekly sessions and each session lasted for 90 min. The same infection control nurse conducted all of the training during the intervention to maintain standardization and continuity of the information. The participating kindergartens sent training reminders to the parents 1 week before each session. Interventions addressing antibiotic use were administrated in two formats: a functional session (Week 1: the basic knowledge on viral and bacterial infections) and an interactive session (Week 2: case studies on consulting behavior, management planning and experience sharing). The parents in the intervention group, together with a pharmacist and an infection control nurse, would join a Facebook Page of Antibiotic 1. Facebook was the most favorite social media platform, 72.4% of Hong Kong population use Facebook [16]. Other potential options were YouTube, Instagram and Twitter. With the features provided by the Facebook, consultation services would be provided via the social network by sending response to query. Qualified professionals from the team would answer these queries. The online platform would post news about antibiotic use or antimicrobial resistance twice weekly, and allow interactions among users, thus strengthening parent-to-parent support.
To facilitate evaluation of the participating parents, assessment packets containing two questionnaires and reminders to parents were sent to the participating kindergartens for dispatch to the intervention and control groups for use before the 2-week period. One participating parent of each child was asked to complete one set of questionnaires before and immediately after the program. The participants were instructed to fill out the questionnaires only once irrespective of the number of children attending the same kindergarten. The questionnaires took 20 min to complete.
The ethical approval for the study was obtained from the Human Research Ethics Committee of The Education University of Hong Kong (REF 2018-19-0122), and participants have provided written consent before taking part in the study. The parents were informed that withdrawal at any time would not result in any negative consequences. All data were protected with passwords. Only the researcher and her team had access to the datasets to prevent any leakage of sensitive information.
Measures
To measure peer support, the peer support outcome protocol adapted from the outcome evaluation indicators [11] was used. Specific outcomes that are available in the protocol include: demographics, service use, program satisfaction, and participation in a discussion group.
Parental knowledge and attitude were measured pre- and post-program using the Parental Perception on Antibiotics (PAPA) scale and the Generalized Self-Efficacy scale (GSE) scale to assess differences, if any, between and within the intervention and control groups.
The PAPA scale was administered to assess the participants’ pre- and post-capability in comprehending and acting on antibiotics-related information (functional: the basic skills in understanding antimicrobial drug knowledge), with Cronbach’s alpha of 0.78. The PAPA scale consists of four sections: 1) Children’s health, 2) Antibiotics and health information, 3) Experience with antibiotics and health professionals, and 4) Personal attitudes and beliefs about antibiotics. It has 32 items measuring the factors influencing the overuse of antibiotics in children, especially those with upper respiratory tract infections. Parents were asked to rate on a 5-point Likert scale ranging from “strongly disagree” to “strongly agree” or from “never” to “always” on child health-related history, including the number of cold episodes and antibiotics (courses) used for the youngest child during the previous year (ranging from “never” to “more than 6 times” a year). Parents were asked if any of their children had contracted any serious infectious or chronic disease. There were also items asking about factors influencing antibiotics resistance and parental use of antibiotics including knowledge and beliefs, behaviors, adherence, information seeking, and awareness, and their perception about doctors’ prescribing behavior [8]. Parents in the control group were only given information leaflets on antibiotics from the Centre for Health Protection. The parents in both groups were required to complete a self-reporting GSE scale questionnaire at pre- and post-intervention. GSE scale is a 10-item measure with a score ranging from 1 to 4 each. Higher scores indicate stronger parental belief in self-efficacy. The Cronbach’s alpha coefficient for the entire scale was 0.80 and the test-retest reliability coefficient was 0.69 [13].
Statistical analysis
Descriptive statistics were used to summarize characteristics of the data to provide information about the intervention and control groups of the participating parents selected from the 12 kindergartens.
Four statistical tests were used in this study. Chi-square tests were undertaken to ascertain differences in baseline characteristics within and across the intervention and control groups. Mann Whitney U tests were conducted to evaluate the significance of differences of the participants’ knowledge and attitude towards antibiotic use between the intervention and control groups. In case of insufficient significant differences on items of interest across the groups for the Mann Whitney U tests, to supplement the deficiency, Wilcoxon Signed Rank Tests would be run instead for the intervention group at the baseline (pre-intervention) and after the training (post- intervention) and differences between these observations would be analyzed for statistical significance. Finally correlation analysis was performed to determine the significance of the relationship between the social support and parents’ personal attitude towards antibiotic use. For the estimation of effects, 95% confidence intervals were used. The statistical significance for all tests was set at p < 0.05.