Internet‐based support program on parenting outcomes for Chinese primiparous women: Study protocol for a randomized controlled trial

Abstract Aim To evaluate the effects of internet‐based support program for primiparous women in terms of improving the levels of maternal self‐efficacy, social support, and satisfaction; and reducing their postpartum depression symptoms. Design A single‐blinded, multicentre, randomized, controlled, parallel‐group pre‐test and repeated post‐test design. Methods Based on the self‐efficacy theory and the social exchange theory, the internet‐based support program has five modules: (a) learning forum of parenting knowledge and skills; (b) communication forum; (c) ask‐the‐expert forum; (d) baby home forum; and (e) reminder forum. Primiparous women will be recruited in the obstetric wards of two university‐affiliated hospitals in China. The participants (N = 258) will be randomly allocated to the intervention group that receive routine care and access to the internet‐based support program and the control group that receive routine care during the 3 months postpartum. Maternal self‐efficacy, social support, and postpartum depression symptoms will be measured at baseline, immediately after the intervention (post‐test 1) and 3 months after the intervention (post‐test 2). The study was funded in January 2018 and was ethically approved in May 2020. Discussion If the internet‐based support program has positive outcomes, it will contribute to the scientific and practical knowledge of nursing interventions to support primiparous women on parenting; and could become the routine health care for health professionals to enhance parenting ability and mental well‐being of new mothers. Impact As the first RCT study on parenting outcomes using a rigorous research design and a theoretical framework in China, this research will contribute to evidence on the effectiveness of using internet platform to support women after childbirth. The results could help to advance research about the use of internet‐based intervention methods to improve women's maternal self‐efficacy, social support, satisfaction, and to alleviate depression symptoms. Chinese Clinical Trial Registry: ChiCTR2000033154

Evidence suggested that the traditional face-to-face interventions of parenting did have an effect; however, the feasibility and generalizability of traditional interventions were challenged by the huge number of primiparous women, the insufficient financial commitment to health care from the government (5.5% of the GDP), and the shortage of health professionals in China (Zhu, Ebert, Liu, & Chan, 2017). Fortunately, the development of E-health and M-health technologies provides alternatives to promote interaction between health professionals and patients outside the clinic (Mobasheri et al., 2014). Due to its convenience and increased accessibility, internet has potential to provide a promising platform for medical interventions (Zhu et al., 2017). In 2019, 61% of the Chinese population used the internet via mobile or computer devices (China News, 2020). The support program based on internet could provide an innovative and easily accessible intervention approach that can reach larger groups of women (Van den Berg, Gielissen, Ottevanger, & Prins, 2012). In Finland, a quasi-experimental design was used to evaluate the effectiveness of an internet-based intervention to support maternal satisfaction and MSE (Salonen et al., 2011). To the best of our knowledge, no RCTs by internet have been conducted in China on parenting outcomes for primiparous women.

| BACKG ROU D
Transition to motherhood will bring various changes to the lives of women, who need to gain parenting knowledge and skills, adjust to the new household relationship, and fulfil self-expectations as mothers (Salonen et al., 2011). Many women find it difficult to manage these physical, social, and psychological challenges in the early motherhood (Kunseler, Willemen, Oosterman, & Schuengel, 2014;Law et al., 2019); especially for the first-time mothers owing to the lack of previous parenting experience ( Leahy-Warren & McCarthy, 2011).
The traditional face-to-face interventions, such as lecture and home visiting, were proved to be effective in the improvement of parenting outcomes; however, the feasibility and generalizability of these traditional interventions methods were challenged by the huge number of primiparous women and the shortage of health professionals in China. Thus, the alternative, innovative, and easily accessible intervention approach need to be designed. Evidence showed that internet interventions can contain more channels of media to tailor information, reach larger groups of women, and can provide more anonymity compared with face-to-face interventions (Van den Berg et al., 2012). Therefore, the internet-based support internet-based intervention, maternal self-efficacy, nursing, postpartum depression, primiparous women, social support program (ISP) for Chinese primiparous women will be conducted to improve their parenting ability, social support, and well-being.
The theoretical framework of ISP was based on the Bandura's self-efficacy theory (Bandura, 1997) and the social exchange theory (House, 1981). Bandura (1997, p.3) defined self-efficacy as "a belief in one's abilities to organize and execute the course of action required to attain a goal or perform a certain task" and believed that self-efficacy affected the regulation and maintenance of behaviour.
Four major elements were identified that affected self-efficacy: (a) previous experience; (b) vicarious experience; (c) verbal persuasion; and (d) physiological and emotional states (Bandura, 1997 Social support involves both the perception of available assistance and satisfaction with received support (Tietjen & Bradley, 1985); and could be conceptualized by structural and functional components (House, 1981). The structural social support has been conceived as social network, which may be informal (family members, friends) or formal (health professionals), depending on the relationship with its recipient. The functional social support has been conceived as informational, instrumental, emotional, and appraisal support (House, 1981).
It is said that the appropriate levels of self-efficacy and social support are essential components of interventions to improve maternal parenting outcomes (Shorey, Chan, Chong, & He, 2015b). The ISP aims to enhance MSE and social support to promote mothers' ability to complete various parenting tasks, thus, improving their psychological well-being. The multicomponent intervention of ISP program includes a learning forum, a communication forum, an ask-the-expert forum, a baby home forum, and a reminder forum that derived from the four factors of the self-efficacy theory and the functional and structural social support concepts of the social exchange theory. For example, in terms of self-efficacy theory, the previous experiences involve

| Aim
This study aims to evaluate the effects of ISP for Chinese primiparous women in terms of improving the levels of MSE, social support, and satisfaction; and reducing their postpartum depression symptoms.
The study hypothesizes that compared with the control group at baseline, post-test 1, and post-test 2, women in the intervention group will report statistically significant: 1. Improved MSE and social support; 2. Reduced postpartum depression symptoms; and.
3. Great satisfaction with healthcare received after childbirth.

F I G U R E 1
The theoretical framework of the ISP adapted from Shorey et al. (2015b) (Schulz, 2011) flowchart is presented in Figure 2.

| Study setting and participants
The research will be carried out in the two university-affiliated tertiary public hospitals in China, where the live births in each study hospital are over 2,000 babies per year. The inclusion criteria will be: first-time mothers with healthy babies; aged 18 years or above; married; and able to response the questionnaires. Exclusion criteria will be: women or their children have severe physical and mental diseases.
Sample size will be estimated based on previous research with a medium to small effect size (Cohen, 1992). With a power of 0.80, an alpha set at 0.05, and an effect size of 0.35 for the primary outcome of PPD (EPDS scores), each group will be 90 women (Gao et al., 2012). We estimate a 30% attrition rate based on an attrition rate of 9%-29% in previous research (Gao et al., 2012). A minimum of 258 women (129 in each group) are required.

| Recruitment
Participants will be recruited when women are admitted in the obstetric wards of hospitals. The obstetric nurses will introduce the ISP to women who meet the inclusion criteria. Posters and leaflets about the program also will be strategically distributed in the obstetric wards to inform all women and their family members. Women who verbally agree to participants will be approached by the researchers to provide them with an information sheet and to answer their any questions about the research. In this approach, women were not asked to give consent as it was considered important to make sure that women had enough time (at least 1 day) to read the information sheet, think about participation, and discuss it with their family members. The researchers will acquire participants' written informed consent on the next day.
The recruitment period is expected to extend over a 3-month period. Data will be collected before randomization (baseline), immediately after the intervention (post-test 1), and 3 months after the intervention (post-test 2). Recruitment of participants began in May 2020.
Primary endpoints (baseline and post-test 1) and follow-up measure (post-test 2) will be expected to be completed in January 2021.

| Randomization and blinding
The Research Randomizer will be used to randomly assign participants into the experimental group and the control group with a distribution ratio of 1:1. The allocation sequence will be put into the opaque and sealed envelopes. Blinding will not be possible for the researchers during all the research process; however, the group allocation will be masked during the recruitment until the baseline measures are completed. In terms of trial participants, outcome assessors, and data analysts, they will be blinded to the participants' group allocation.

| Intervention
The women in the control group will receive routine care. Routine care consists of supports from the obstetricians and obstetric nurses during the 3-5 days hospitalization; and home visits from the community doctors on the 3rd, 7th, 14th, and 28th days postpartum (Zheng, Morrell, & Watts, 2015). The women in the study group will have access to the ISP and receive routine care in the postpartum period. The details of intervention are described in  The researchers will teach women in the intervention group how to log in and use each module of ISP by mobile phone or computer.
The original username and password of women will be setup by the researchers; and can be changed by women later. The frequency and duration of the logins will be monitored to evaluate the women's adherence. Technical assistance will be available on the weekdays by telephone or email.

Primary outcomes
MSE. MSE will be evaluated by the Self-efficacy in Infant Care Scale (SICS) (Prasopkittikun & Tilokskulchai, 2010). The SICS is a 46item scale comprising of four dimensions. Each item indicates one parenting task rated from 0 to 100 points. A higher SICS score means a higher level of MSE. The SICS has demonstrated good psychometric properties. The reported internal consistency was 0.96 for the total scale and ranged from 0.86 to 0.96 for its dimensions (Prasopkittikun & Tilokskulchai, 2010). In terms of Chinese version SICS, its Content Validity Index (CVI) was 0.98; and the internal consistency was 0.95 for the scale and was in range 0.80-0.93 for its dimensions (Zang & Sheng, 2010).
PPD. PPD will be assessed using the Edinburgh Postnatal Depression Scale (EPDS) (Cox, Holden, & Sagovsky, 1987). The scale is a 10-item 4-point Likert instrument to detect PPD. The self-report scale's score ranges between 0 and 30 and the higher  (Wang et al., 2009).
Social support. Postnatal social support will be measured using the Postpartum Social Support Scale (PSSS), developed for Chinese women to measure their perceived social support after childbirth (Lu & Zheng, 2001). The scale is a 20-item four Likert self-report tool and its score is in range 0-60 overall. The higher score equates to the more social support a mother receives. The Cronbach's alpha coefficient of PSSS was 0.89 and the content validity of this tool was 0.90 (Lu & Zheng, 2001).

Secondary outcomes
Satisfaction with healthcare. Women's satisfaction with health care after childbirth will be assessed with a 3-item questionnaire developed by the researcher. For instance, "Overall, how satisfied you are with the healthcare?", "Please give your reasons", and "Please give your suggestions".

Other outcomes
Social-demographic and clinical data. The collected data comprise the maternal age, marital status, educational level, occupation, family income, mode of birth, baby gender, baby health, and baby fussiness via women's self-report.
Internet usage data for the ISP. Internet use data, such as the frequency and duration of logins and the website activity of each module of the ISP, will be recorded and evaluated by a tracking system from the website.

| Data collection procedure
The baseline assessment will be conducted by the researchers and every participant will be asked to complete the SICS, EPDS, PSSS, and social-demographic and clinical data in the obstetric wards. Post-test 1 will be carried out immediately after the intervention and Post-test 2 will be conducted on 3 months after the intervention. At the two time points of Post-tests 1 and 2, the questionnaires comprised of SICS, EPDS, PSSS, and healthcare satisfaction will be sent to participants by wechat or email; and the completed questionnaires will be returned to the researchers by wechat or email. To improve the response rate, a kindly telephone or wechat reminder will be given to participants before and after one week of the two time points, respectively.

| Data analysis
Data will be analysed using the Statistical Package for Social Sciences (SPSS). An intention-to-treat analysis (ITT) will be adopted to manage missing data. Descriptive statistics were conducted to describe the sociodemographic and clinical characteristics of primiparous women by means and standard deviations (SDs); frequencies and proportions. The chi-square (χ2) and the independent sample t test will be used to detect any significant difference between the study and control groups on the baseline variables.
Adjusted for possible confounding factors of sociodemographic variables, the repeated measures triply MANCOVA will be conducted to determine whether the intervention of ISP is effective in enhancing MSE and social support and for reducing PPD across the three time points of data collection (baseline, post-test 1, and post-test 2). The independent t test will be used to compare how satisfied the intervention group and the control group are with the health care that they received after childbirth on the two time points of immediately after the intervention and 12 weeks after intervention.

| Ethical considerations
Research ethical committee approval is obtained by the Research Ethics Committee of Health Science Center in a University of China (approval number 2,020,011). The registration number with the Chinese Clinical Trial Registry is ChiCTR2000033154. This study will adhere to ethical standards for the whole procedure. There is no potential risk or harm by participating in this program. Women will not be deprived of any treatment and routine care. The written informed consent will be obtained from every participant before data collection. Women will be informed of freedom to withdraw at any time and are assured of anonymity by using special code numbers to identify themselves. All of the collected data will be kept anonymously and confidentially.

| Validity and reliability
This study adopts the rigorous research design, such as the sound theoretical framework, a RCT design with a good representative and predetermined sample, the use of instruments with a high validity and reliability, and statistically scientific analysis, which can be seen to reduce bias effectively and enhance the generalizability of research results beyond the target population. Moreover, outcome assessors and data analysts of the research will be blinded after assignment to interventions to reduce the biases in evaluation of the effects of the intervention.

| D ISCUSS I ON
To my knowledge, this study will be the first RCT by internet on parenting outcomes for Chinese primiparous women. If the ISP program has positive outcomes, it will contribute to the scientific and practical knowledge of nursing interventions to support primiparous