We designed a randomised clinical demo to consider the performance of On the net Good Parenting Programme (On-line PPP) in balanced caregivers and their 3- to 6-calendar year-old children. Table 1 lists the developmental method of On the net PPP with even more explanation on the different periods, formats, and contents. Immediately after created educated consent have been acquired from all major caregivers, members were being randomised working with computer system-generated block of 4 allocations, into two parallel groups, intervention as opposed to energetic comparator control teams, by K.J. Info had been obtained from all contributors at baseline, 8 weeks (completion of intervention phase), and 14 weeks right after the intervention began. All individuals were being presented info about the research and gave consent. This trial was registered on the Thai Medical Trial Registry (TCTR20201030001 on 30/10/2020), and described in accordance to the Consolidated Specifications of Reporting Trials (CONSORT) Tips.
Sample measurement calculation
We employed G*Electrical power model 18.104.22.168 to determine sample dimensions which originally yielded 86 parent–child dyads in the Online PPP intervention team and the active comparator manage group assuming the outcome sizing of .15, alpha .05, power 80% with 15% attrition amount. Even so, based on prior reports with worries of the risk of increased dropout prices thanks to COVID-19 pandemic3,20,22, we resolved to use the goal sample size as 103 parent–child dyads to account for 40% attrition level.
Qualified study individuals were healthful mom and dad and children aged 3–6 years who experienced no or nominal possibility of psychological and behavioural difficulties. We recruited members as a result of a social community platform: the Facebook webpage of our division. All contributors obtained secure online screening kind to determine eligibility. Inclusion requirements had been as follows: (1) healthful key caregivers of children aged 3–6 years at the time of recruitment, (2) acquiring minimal worry concentrations (Parental Strain Scale ≤ 7220 and Parent Stress Index—Short Form < 8634) without mental health illnesses, (3) children with birth weight ≥ 2500 g and no history of pre-, peri-, and postnatal complications, (4) healthy children who had normal developmental screening by Developmental Surveillance and Promotion Manual (DSPM)35, (5) children with normal behavioural screening by Strengths and Difficulties Questionnaire (SDQ) defined as having total difficulties score of ≤ 1811 and no mental health problems, and (6) the primary caregiver had access to a telephone, computer, and an internet connection in their home.
Participants were excluded if: (1) their child had history of developmental delay or severe behavioural problems, or (2) their child was not able to attend in-person developmental evaluation at King Chulalongkorn Memorial Hospital.
Eligible participants were randomised into two groups: the Online PPP intervention group and the active comparator control group separate LINE (Line Corporation, Tokyo, Japan) OpenChat groups were created for each group whereby participants could not directly contact other participants. The participant flowchart (CONSORT diagram) is presented in Fig. 1.
At 8 and 14 weeks after the start of the intervention, both groups of participants received a message through a communication application (LINE OpenChat) to complete the follow-up assessments. A reminder message was sent to alert participants if they had not completed the assessments. A follow-up telephone call was made to the participant if the assessment was not completed after 2 reminders. Project participants were given 500 Baht (equivalent to £10.96) per person for participating in the project and completing the assessment at every time point.
Between October to December 2020, participants in both the Online PPP intervention group and the active comparator group received similar weekly general parenting education via group communication application (LINE OpenChat groups) for 8 weeks in the forms of text articles or videos.
In the Online PPP intervention group, intensive video conferencing via Zoom platform (Zoom Video Communications, Inc., San Jose, California, USA) was conducted once a week, with the scheduled date, time, and link, and the reminder for each session’s attendance sent via the LINE OpenChat. Each video conference session took 90–120 min and utilised transformative learning theory. As the sessions were held in many formats, some sessions were very interactive with many small breakout groups with trained facilitators where the parents practiced communication skills in different case scenarios. Some sessions started with a designated speaker discussing storytelling or planning daily routines and ended with a large group discussion. The entire intervention sample attended the same sequential group session spanning 8 weeks. The content included empowering parents, shifting the focus back to building a good parent–child relationship, fostering positive and effective communication, mastering behaviour modification techniques, organising daily life routine, supporting self-care of parents, promoting development through play and storytelling (Supplementary Table 1). Recorded videos of the live session were edited and available for parents who were unable to attend each week’s activity. Furthermore, participants in the intervention group were able to ask specific questions about learning contents and their concerns regarding their children’s behaviours via Line OpenChat during the intervention period, whereas such concerns raised by participants in the control group were not responded to until study completion at 14 weeks. In addition, the intervention group also received weekly video clips on general education, which were also provided to the active comparator group.
Active comparator group
The active comparator group received succinct, weekly video clips on general education. General education topics consisted of bilingualism, appropriate sleep for pre-schoolers, appropriate learning environment, fine motor skills, self-help skills, feeding difficulty, electronic media use in children and bullying. All these video clips were sent via Line communication application. Such above weekly video clips on general education were also sent to the intervention group.
At baseline, we collected demographic data including parents’ sex, age, marital status, and education level. Data on household income, child’s age, and sex were also recorded. Primary outcome was parental competence and secondary outcomes were parenting skills, parental stress and child’s behavioural problems assessed at baseline, 8 weeks (end of intervention phase), and 14 weeks after the intervention began.
Parenting sense of competence
The Parenting Sense of Competence Scale Thai Version (PSOC), a validated questionnaire, consisted of 17 self-report and self-administered items assessing parent’s perception of their own parenting performance16,36. To date, the PSOC tool was designed for parents of children aged 0–17 years old36. PSOC scale had 2 categories: skill/knowledge 8 items and perceived value/comfort 9 items with the internal consistency for skill/knowledge of 0.73 and perceived value/comfort of 0.80. Total scores could range between 17 and 102 points with higher total scores suggesting a higher sense of parenting competence.
Parenting Styles and Dimensions Questionnaire-short version (PSDQ-short version): Thai version included 32 self-report items evaluating different parenting styles in each parent including authoritative, authoritarian, and permissive parenting style. The internal consistency of the PSDQ (short version) in 3-year-old children were 0.80, 0.75, and 0.62 for authoritative, authoritarian, and permissive parenting style, respectively37. Such variables were relatively comparable to a pioneering work by Robinson et al. which demonstrated the internal consistency of 0.86, 0.82, and 0.64 for authoritative, authoritarian, and permissive parenting style, respectively38.
Parental Stress Scale (PSS) had 18 Likert-scale, self-administered questions regarding the degree of parental stress with the alpha coefficient of 0.83 and test–retest reliability of 0.8139. Parental Stress Scale, Thai version was divided into 8 positive items and 10 negative items with Cronbach’s alpha coefficient of 0.81 and reliability of 0.8913. Possible scores ranged between 18 and 90 with higher scores indicating higher parenting stress level.
The Thai version of the Parenting Stress Index-Short Form (PSI-SF) was a self-report, 36-item questionnaire assessing both parenting stress and particularly the stress in child-parent relationship with Cronbach’s alpha coefficient of 0.9434. The questionnaire was divided into 3 areas as follows: (1) Parental Distress (PD): 12 items, (2) Parent–Child Dysfunctional Interaction (P-DI): 12 items, and (3) Difficult Child (DC): 12 items. Responses were based on a 5-point Likert scale with total score higher than the 85th percentile or a raw score ≥ 86 points representing clinically significant parenting stress level.
Child’s behavioural concerns
Strengths and Difficulties Questionnaire (SDQ) was a highly reliable, 25-item, 3-point Likert scale questionnaire assessing behaviours of children aged 4–16 years11. Higher scores for conduct problems, hyperactivity, emotional problems, and peer problems, and total difficulties, sum of the 4 aforementioned domains, indicated greater behavioural problems.
Baseline data from all randomised participants were summarised by treatment group. Continuous variables are presented as means and standard deviations and categorical variables as frequency and percentage. Primary and secondary outcomes were summarised descriptively by treatment group at each time point. The primary and secondary outcomes analyses used the intention-to-treat (ITT) population that included all randomised participants. All study outcomes within groups at both 8 and 14 weeks were analysed using Paired t-test. Analysis of Variance (ANOVA) was performed to analyse outcomes between groups at 14 weeks. For the outcomes that were not normally distributed and measured at various time points, we used Generalised Estimating Equations (GEE) model to estimate the parameters of a generalised linear regression and determine the interaction between 2 groups over 3 time points. We adjusted potential confounding factors including household income, caregiver’s age, education, number of child’s siblings, child’s age, and gender. Moreover, we applied natural log transformation to adjust the non-normally distributed data for GEE analysis. GEE was computed with mean values, standard error (SE), and Wald test for each independent variable. Statistical significance was defined as p values < 0.05. Statistical analyses were performed using SPSS statistical software version 22 (IBM Inc., Bangkok, Thailand) for windows with the support from Chulalongkorn University.
This study was approved by the Institutional Review Boards of the Faculty of Medicine, Chulalongkorn University (IRB 310/63). All procedures were performed in accordance with the International Council on Harmonisation (ICH) Guidance for Industry, E6 Good Clinical Practice: Consolidated Guidance (ICH-E6) to ensure research integrity and protect human subjects.