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Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period.
The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program.
A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth.
Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017.
This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents’ social support–seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore’s ailing birth rate.
International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http://www.webcitation.org/6wMuEysiO)
The addition of a newborn to a family unit necessitates an environment of change and uncertainty [
In view of the dipping fertility rate [
To assist parents in transiting smoothly into parenthood, antenatal classes and postnatal educational sessions are available at the hospitals in Singapore [
Previous local studies were mainly focused on first-time mothers [
With the advancement in technology, the use of technology-based educational programs with new parents during the postnatal period both internationally [
The theoretical framework guiding the SEPP is Bandura’s self-efficacy theory and Bowlby’s attachment theory [
The aims of the study were to (1) examine the effectiveness of the SEPP on parental outcomes, including PSE (primary outcome), parental bonding, postnatal depression and anxiety, social support, and parenting satisfaction; (2) evaluate the cost-effectiveness of the SEPP compared with routine perinatal care; and (3) process evaluation of the SEPP by assessing its strengths and weaknesses from parents’ perspectives.
The hypotheses are (1) When compared with those in the control group receiving routine care, parents receiving the SEPP will report significantly (a) higher levels of self-efficacy in newborn care, (b) higher levels of parental bonding, (c) lower levels of depression and anxiety, (d) higher levels of social support received, and (e) higher levels of parenting satisfaction and (2) It is more cost-effective to provide the SEPP than routine care.
Theoretical Framework showing interrelationship between outcome variables. SEEP: Supportive educational parenting programme; PSE: Parenting self-efficacy; PB: Parental bonding; PND: Postnatal depression; PS: Parenting satisfaction; SS: Social support.
A randomized controlled two-group pretest and repeated posttest experimental design will be used. Couples (n=118 participants) recruited from a tertiary hospital will be randomly assigned into the two groups (intervention group receiving the SEPP and routine care or control group receiving only routine care). Data will be collected via questionnaire surveys using locally validated and reliable instruments, medical reviews, semistructured face-to-face interviews, and telephone interviews.
Parents who are assigned to the intervention group will receive the SEPP and routine perinatal care provided by the hospital. Parents in the control group will receive only routine care. The routine care includes antenatal check-ups with an obstetrician and short postnatal stays in the hospital. During antenatal check-ups, the progress of the pregnancy is assessed via maternal bio-physiological profile, height and weight, and abdominal palpation. Antenatal educational classes are available; however, they are charged and not fully utilized by parents because of their lack of awareness [
In Singapore, the mobile phone penetration rate was approximately 98% in 2016 [
Details of the Supportive Parenting Educational Program.
No.a | |||
1 | Telephone-based antenatal educational session | 30 min | Parental self-efficacy and bonding (eg, definitions of parental self-efficacy and bonding, why are they important, and how they can be enhanced Expectations in the immediate postpartum period Emotional needs of parents both during pregnancy and after the child’s birth |
2 | Telephone-based immediate postnatal educational session | 60 min | Reinforcement on the topics covered during antenatal period, including parenting self-efficacy, parental bonding, and postnatal depression Coverage on parent-craft class topics including baby bathing and breastfeeding Role of fathers during postnatal period |
3 | mHealthb app-based follow-up educational session | 1 month access to the mHealth app | A knowledge-based content on topics including newborn and maternal care Audio recordings of the knowledge-based content Videos on various newborn care tasks such as baby bathing and breastfeeding demonstrated by a trained midwife using a live baby. Each video is approximately 8 min long on average A discussion forum Push notifications |
aNumber in series.
bmHealth: mobile health.
The knowledge-based content in the mHealth app includes evidence-based information on ways to enhance parental self-efficacy and bonding, newborn care and maternal self-care tasks, emotional challenges and ways of dealing with it, breastfeeding-related information, and insights for new parents for a smooth transition to parenthood. The discussion forum will be a platform for parents to ask any questions they might have. All parental queries will be answered by a trained midwife (research assistant 1, RA1) once a day for the first 4 weeks post childbirth because this period is the most stressful period for new parents in the early post-partum period [
To ensure consistency, the same RA (RA1) will deliver the telephone-based prenatal and postnatal educational component in the SEPP to all the participants in the intervention group. The protocol for the SEPP has been validated by an expert panel consisting of five HCPs (one nursing professor who is experienced in postnatal educational programs, one senior consultant-neonatologist, one senior consultant-obstetrician, and two experienced midwives in perinatal education) and two sets of parents.
Screenshot of knowledge-based content.
Screenshot of audio recordings.
Screenshot of discussion forum.
Screenshot of videos.
Screenshot of push notifications.
Are 21 years and above
Are able to read and speak English
Have low-risk singleton pregnancy with more than 28 weeks of gestation
Have a mobile phone with Internet access
Plan to stay in Singapore for the first 3 months post delivery
Have self-reported physical or mental disorders that will interfere with their ability to participate in the study
Have high-risk pregnancy, including placenta-previa major, preeclampsia, and pregnancy-induced hypertension
Have complicated assisted delivery such as vacuum or forceps with 4th degree perineal tear of the mother
Gave birth to a stillborn or a newborn with congenital abnormalities or medical complications, or
Are a single parent
The participants recruited will be couples (a father and mother dyad is considered one couple). The inclusion and exclusion criteria for participants who are mothers are shown in
The inclusion criteria for fathers are those who (1) are 21 years and above, (2) are able to read and speak English, (3) have a mobile phone with Internet access, and (4) plan to stay in Singapore for the first 3 months post delivery. The exclusion criteria for fathers are those who have self-reported physical or mental disorders that will interfere with their ability to participate in the study and/or are a single parent.
All couples are recruited antenatally and will be told beforehand that they may be excluded from the study if mothers are to experience complication during their pregnancy and the delivery of their newborn.
On the basis of previous studies, psychosocial and educational interventions in the perinatal period generally produce a medium size effect on outcome variables [
The research randomizer will be used to randomly generate one set of 59 numbers ranging from 1 to 118. Generated numbers are assigned to the intervention group and the remaining to the control group. All 118 numbers will be placed in an opaque envelope. The principle investigator who will not be involved in the recruitment will hold the random numbers and pass it to RA1 for recruitment. After assessing eligibility and obtaining informed consent, the participants will be asked to pick a number from the opaque envelope, in which the number picked will determine the groups assigned.
Patients’ demographic data (eg, age, gender, ethnicity, and education) will be collected. In addition, the following instruments will be used to measure parental outcomes:
Parenting Efficacy Scale (PES): This 10-item PES scale [
Parent- Infant Bonding Questionnaire (PIBQ): This is an 8-item, 4-point Likert scale used to measure the parental bonding of both parents [
Edinburgh Postnatal Depression Scale (EPDS): This is a 10-item scale widely used to measure parents’ postnatal depression [
State Trait Anxiety Inventory (STAI): This is a 40-item 4-point Likert scale used to measure parental anxiety level. The total score for the STAI ranges from 40 to 160, with higher scores indicating greater levels of parental anxiety. The scale has been tested widely in various studies [
Perceived Social Support for Parenting (PSSP): This is a 4-item scale [
What Being the Parent of a Baby is Like (WBPL): The evaluation subscale of the WBPL will be used to measure parenting satisfaction [
Health care utilization and program-related expenses sheet: This sheet will be used to capture all direct health systems cost related to health care services utilized antenatally and postnatally because of maternal or infant related health issues such as hospital admissions and outpatient contacts, health professional’s time, program-related time, and during pregnancy, for the first and 3rd month after delivery. The study will take an
A semistructured interview guide will be used for the process evaluation. Individual face-to-face interviews will be conducted immediately after the intervention (1 month post birth) to identify strengths and weaknesses and to comment on the content, activities, effectiveness, and delivery methods of the SEPP for participants in the intervention. Parents in the control group will be asked to comment on the current routine perinatal care provided by the hospital. All interviews will be audiorecorded.
The study consists of two phases: (1) planning intervention strategies for the intervention group, including the development of the educational content to be covered during the antenatal and postnatal periods and the development of the mHealth app, audio, and videos related to postnatal care, and (2) implementation of the SEPP and investigating its effectiveness on parental outcomes.
This study has been approved by the ethics board, and recruitment at the antenatal clinics has started at the study venue. The principle investigator and her team will inform nurse managers and clinicians at the antenatal clinics before a RA (RA1) commences the process of recruitment. Before contacting potential participants, the attending nurses and/or clinicians will be approached to assess each couple’s physical and psychological well-being before inviting them to participate in the research study. The referred couples will once again be assessed using the inclusion and exclusion criteria. There will be no undue influence or coercion used to recruit couples into the study. Each couple will be given details of the purpose of the study and ample time to ask questions and to consider before deciding to participate. It will be strongly emphasized that their participation is solely voluntary and that they may choose not to participate without any harm or compromise in the care they receive. Verbal and written consent will be obtained from the couple, both mother and father, thereafter. Both first-time and experienced mothers, regardless of their parity, who meet the inclusion criteria, along with their partners, will be recruited. RA1 will visit the antenatal clinics regularly to recruit participants according to the inclusion and exclusion criteria and will be responsible for randomizing the participants.
Once consent has been taken, demographic and baseline data of the participants will be obtained, and randomization will take place. In addition, recruited couples will be asked for their contact details so that they can be contacted for subsequent follow-ups. RA1 will keep in constant contact with the participants to ensure the birth of the newborn. For participants in the intervention group, telephone-based antenatal education session will be delivered by RA1 at the participants’ convenience at a prearranged timeslot.
After childbirth, all couples will be reapproached in the postnatal wards by the RA before their day of discharge post childbirth. Before making contact in the postnatal wards, the nurse-in-charge will be approached by RA1 to ensure the physical and emotional well-being of the participants. For participants in the intervention group, the postnatal education session will be delivered by RA1 in the postnatal wards on the day of discharge from the hospital. RA1 will assist parents in downloading the mHealth app and demonstrate the functions of the app before discharge. Participants will also be given individual usernames and passwords for access to the mHealth app. Access to the app will expire automatically in 4 weeks. RA1 will be responsible for answering the queries in the discussion forum and to monitor and correct any inappropriate content shared among parents.
A single-blind technique will be adopted, in which the RA (RA2) responsible for the collection of data post intervention or post discharge will not be aware of the treatment allocation, which will be conducted by another RA (RA1). RA2 will be responsible for the collection of all interim and postintervention data, including the process evaluation interviews. Outcome measures will take place at the following time points for all parents: (1) during pregnancy, before randomization (baseline); (2) after childbirth, before hospital discharge (interim data); (3) post intervention for the SEPP intervention group and at the end of week 4 post childbirth for the control group (posttest 1); and (4) 2 months after the SEPP for the intervention group and 3 months post childbirth for the control group (posttest 2). The period when parents are prone to facing various challenges is at 1 month post birth. Hence, the rationale for collecting posttest 1 data during that time. At 3 months post birth is when some working mothers return to work, signifying a change in environment relating to the rational for collecting posttest 2 data. Before contacting parents for the posttest data, a message will be sent to ensure parents’ availability. In the process of data collection, if either parent feels tired, RA2 will respect the parents’ decision to continue or terminate the data collection to ensure parents’ comfort. The consolidated standards of the reporting trial flowchart for this study is presented in
Process evaluation will be conducted with the main objective of obtaining parents’ opinions and comments of the SEPP intervention. Purposive sampling of parents will be done based on the parenting self-efficacy scores of parents immediately after the end of the intervention (at 1 month post childbirth). This will be done through a semistructured face-to-face interview. Each interview will take approximately 20 to 30 min and will be audiorecorded. Parents will not be included for interview if they refused to be audiorecorded. The recruitment for process evaluation will continue and will only be terminated once the proposed number of interviews is reached or when data saturation is achieved. The semistructured interview guide has been reviewed and approved by the ethics board.
All quantitative data will be analyzed using Statistical Package for the Social Sciences (SPSS) version 24.0 (IBM Corp). Missing data will be replaced (assuming 10%) for intention-to-treat (ITT) analysis. Both ITT analysis and per-protocol analysis will be conducted to compare any differences between groups. Descriptive statistics such as mean, standard deviation, and range for continuous dates, frequencies, and percentages will be used for nominal and ordinal data. Cronbach alpha will be used to test the internal consistencies of the questionnaires. Inferential statistics such as the independent
The consolidated standards of reporting trial flowchart. PIBQ: Parent-Infant Bonding Questionnaire; PES: Parenting Efficacy Scale; EPDS: Edinburg Postnatal Depression Scale; STAI: State-Trait Anxiety Inventory; PSSP: Perceived Social Support for Parenting; and WBPL: What Being the Parent of a Baby is Like.
Qualitative data will be analyzed using thematic analysis [
Ethics approval has been obtained from the National Health Group Domain Specific Review Board (NHG DSRB) before the commencement of the study (Ref. No: NHG DSRB: 2016/00651) in June 2016. All participants are given a set of participant information sheets consisting a brief introduction and the purpose of the study, with the advantages and disadvantages of the study conveyed clearly. The participants are guaranteed anonymity and are informed of the right to withdraw at any point of the study without affecting any subsequent care received.
Phase 1 of the study has been completed. Educational materials for both antenatal and postnatal education, audio and videos files, and the mHealth app have been developed. For phase 2, the recruitment of study participants commenced in December 2016 and is still ongoing. The targeted aim of recruiting 118 couples will be ongoing for a period of 12 months. The total number of participants approached thus far are 211, and 162 were screened (not interested and did not comply to one of the inclusion criteria). The current enrollment is 49 couples (for both the intervention [n=27] and control [n=22] groups). The projected timelines for the completion of the data entry and analysis for investigating the SEPP’s effectiveness on parental outcomes is around December 2017.
Theoretical framework–based and technology-enhanced educational programs have shown effectiveness [
We are hopeful that the provision of this technology-based educational program, which includes telephone calls and an mHealth app, will provide a clinically useful and potentially cost-effective solution to improve parental outcomes. This may eventually lead to more positive perinatal parenting experiences, which may influence the psychosocial well-being of both parents and their newborn, leading to better family dynamics and reducing associated health care and social burdens. It may also impact the future reproductive decisions of parents.
It is worthy to note that this study is being tested in a multiracial population, which enhances its relevance in the local context as participants in the study venue have similar demographic profile to Singapore’s general population, with the majority of its population being Chinese, followed by Malays and Indians. However, being a single-centered study, it limits its generalizability to an international population and requires further evaluation.
analysis of covariance
Edinburg Postnatal Depression Scale
health care professional
intention to treat
mobile health
Parenting Efficacy Scale
Parent-Infant Bonding Questionnaire
parenting self-efficacy
perceived social support for parenting
research assistant
Supportive Educational Parenting Program
State Trait Anxiety Inventory
What Being the Parent of a Baby is Like
The authors would like to thank the National University of Singapore for the National University Health System Clinician Research grant FY2015 (Ref No.: NUHSRO/2016/023/CRG/02). The authors would also like to thank the National University Health System, Medical Publications Support Unit, for assistance in the language editing of this manuscript.
None declared.