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Multiple international agencies, including the World Health Organization and the International Monetary Fund, have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists.
This study protocol aims to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period.
A randomized controlled 2-group pretest and repeated posttest experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either the peer support intervention program or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week and twelfth week post childbirth.
The recruitment and training of peer support volunteers (N=20) ended in June 2017, whereas recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73, with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018.
This study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother-child bond, and enhance overall family dynamics for mothers and infants.
International Standard Randomized Controlled Trial Number ISRCTN14864807; http://www.isrctn.com/ISRCTN14864807 (Archived by WebCite at http://www.webcitation.org/6xtBNvBTX)
The mental well-being of women is highly vulnerable after childbirth, with postpartum mood disorders being the top cause of maternal morbidity [
PND poses a huge mental health threat for women, with recent literature reporting an estimated prevalence rate of 10% to 15% for major PND [
To date, the causes of PND remain uncertain, with considerable amount of literature suggesting a multifactorial etiology [
In previous studies [
In addition, numerous randomized controlled trials [
The scarcity of resources and advancement of technology has led to an increasing trend in telemedicine, which is a previously underutilized platform in the health care sector [
The aim of this study is to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period. This study has 3 objectives:
To evaluate the peer support intervention program on maternal outcomes, including PND (primary outcome), anxiety, loneliness, and social support (secondary outcomes)
To analyze mothers’ evaluations of their peer support experience
To analyze peer volunteers’ evaluations of their peer support experience
We hypothesized that when compared with those in the control group receiving routine care, mothers receiving the peer support intervention program will report a significantly lower level of PND, lower level of anxiety, lower level of loneliness, and higher level of social support received.
A randomized controlled, single-blinded, 2-group pretest and repeated posttest experimental design will be used. Mothers (n=118) recruited from the postnatal wards of a tertiary public hospital will be randomly allocated to 2 groups (intervention group receiving the peer support intervention program and routine perinatal care from the hospital or control group receiving only routine perinatal care from the hospital). Data will be collected at immediate postnatal period (on day of discharge from the hospital), at the fourth week, and the twelfth week post childbirth using Web-based questionnaire surveys that include locally validated and reliable instruments, semistructured face-to-face interviews, and telephone interviews.
Potential participants must be mothers who (1) are at least 21 years old, (2) can speak and read English, (3) own a telephone and are willing to share their number, and (4) plan to stay in Singapore for the first 3 months post childbirth. The inclusion criteria for the peer volunteers are mothers who (1) are at least 21 years old, (2) can speak and read English, (3) have delivered healthy baby in the past, (4) have self-reported history of and recovery from PND, (5) have a phone and are willing to share their number and call needy mothers as instructed by the research team, and (6) plan to stay in Singapore for next 6 months from the time of recruitment to participate in the mother-to-mother peer support intervention program. The exclusion criteria for the participants are mothers who (1) have a history or existing psychiatric illnesses, cognitive impairment, “and” or “or” major medical conditions that can interfere with their ability to participate in the study, (2) have had a vacuum- or forceps-assisted delivery with fourth-degree perineal tear; and/or (3) has given birth to a stillborn or a newborn with birth defects and/or medical complications. The exclusion criteria for the peer volunteers are as follows: (1) they have any physical or mental disorders that can interfere with their ability to participate in the study and (2) do not want to share their number and call needy mothers as instructed by the research team.
Mothers who participate in the intervention group will receive technology-based peer support alongside routine postnatal care by the hospital, including follow-ups by the obstetrician, nurses, and lactation consultant. Mothers in the control group will only receive standard routine postnatal care provided by the hospital. Research assistant one (RA1) will match the participant to the peer volunteer based on availability [
Peer Voluntary Activity Log. Overall rating: 1 least satisfied; 5 most satisfied.
Psychosocial and educational interventions in perinatal period often result in a medium to large effect size on outcome variables [
After confirming the eligibility criteria and obtaining the consent of the participants, all mothers will be randomized into 2 groups. Mothers who give consent to participate will be asked to choose a number from 1 to 118 from an opaque envelope. The research randomizer [
After the peer support intervention (between 4 and 12 weeks post childbirth), an approximate purposive sample of 20 mothers, 10 each from intervention and control groups (actual number will depend upon data saturation), and all (N=20) peer support volunteers will be selected to participate in the interview to obtain their opinions and comments on the receipt and delivery of the peer support intervention program, respectively. Participation in the interviews will be voluntary. The process evaluation of each interview will take approximately 30-60 min. Participants will be given pseudonyms during the interviews to protect their actual identities. As part of the presentation of the results, their own words will be used in text and will be made anonymous. The interview will be audio-recorded and transcribed into text form. The recruitment will continue until the proposed number is achieved or data saturation is achieved, whichever occurs earlier.
The demographic data of mothers (eg, age, gender, ethnicity, education) will be collected. The following instruments will be used to measure the outcomes.
The Edinburgh Postnatal Depression Scale (EPDS) [
The Patient Health Questionnaire (PHQ-9) [
The State Trait Anxiety Inventory (STAI) [
The University of California, Los Angeles (UCLA) Loneliness scale [
This 4-item instrument developed by Leerkes and Crockenberg [
A semistructured interview guide will be used for process evaluation. Individual telephone or face-to-face interviews with mothers and peer volunteers will be conducted (4-12 weeks post childbirth) to identify the strengths, weaknesses, and effectiveness of the intervention (from the mothers’ and peer volunteers’ perspectives) as well as on the delivery process from the peer volunteers. All interviews will be audio-recorded.
The study will be composed of 2 phases:
Phase 1: Planning intervention strategies for intervention group, including recruitment of peer volunteers, development of peer volunteer training manual, and training the peer volunteers.
Phase 2: Implementing the PIP and investigating its effectiveness on maternal outcomes.
The recruitment of peer volunteers in phase 1 was conducted before the recruitment of participants. Recruitment was done through the blasting of emails to the study venue working community and through word of mouth. On the basis of a previous study [
Peer volunteers were required to attend a 4-hour training session conducted by the psychiatrist (one of the study team member). The training for all recruited volunteers was completed in one session in June 2017 to maintain standardization. The training session included roleplaying and discussions to provide necessary skills for the peer-volunteers to successfully deliver the intervention. Peer volunteers were also trained in assessing and conducting the appropriate referrals to relevant health care professionals should the need arise. A peer volunteer training manual was distributed during training to facilitate and guide the intervention process. The trial was introduced during training sessions, and all peer volunteers who agree to participate were required to fill a demographic form and were provided activity logs to account for their sessions with the mothers.
For phase 2, ethics approval has been granted (NHG DSRB: 2017/00815), and participant recruitment has commenced in the postnatal clinics at the study venue. RA1 has informed the nurse managers and clinicians of the respective postnatal wards of the study. The nurse in charge creates a short list of eligible participants based on the selection criteria and verifies the overall physical and psychological well-being of the women. RA1 then approaches those women who meet the inclusion criteria and explains the study purpose and details to them. Voluntary participation is emphasized. Those who are keen to participate are screened using EPDS. On the basis of previous studies [
A single-blinded technique is used. Research assistant two (RA2), who is not part of the randomization and is not involved in the intervention, collects all data and will conduct the process evaluation interviews to avoid bias. Outcome measures of depression, anxiety, loneliness, and perceived social support are collected by RA2 primarily through a Web-based questionnaire, unless the mothers request for an alternative mode, such as through phone call, face-to-face, or via mail. Follow-up time points for all mothers are as follows: (1) immediately after the post birth when discharged from the hospital (baseline), (2) 4 weeks postpartum, and (3) 12 weeks postpartum. Between week 4 and week 12 postpartum, RA2 will invite mothers each from the intervention and control groups to participate in a semistructured process evaluation interview either face-to-face or by telephone. Participation is strictly voluntary. RA2 will also conduct process evaluation interviews with peer volunteers once they are done administering technology-based support to the assigned mothers. The activity logs will also be collected by RA2 for further evaluation. The PND at 12 weeks is chosen as the primary outcome because the results suggest that most PND develop within this time period [
Consolidated Standards of Reporting Trial Flowchart. EPDS: Edinburg Postnatal Depression Scale; PHQ-9: Patient Health Questionnaire 9; STAI: State Trait Anxiety Inventory; UCLA: UCLA Loneliness Scale; PSSP: Perceived Social Support for Parenting.
All quantitative data will be analyzed using the latest version of IBM SPSS. Missing data will be replaced for intention-to-treat analysis. Both intention-to-treat and per-protocol analyses will be conducted to compare the differences between groups. Descriptive statistics, such as mean, standard deviation, and range for continuous data and frequency as well as percentages, will be used for the nominal and ordinal data. Cronbach alpha value will be used to examine the internal consistency of the questionnaires. Inferential statistics, such as independent sample
Qualitative data from the interviews will be analyzed using the thematic analysis [
Ethics approval has been obtained from the National Health Group Domain Specific Review Board before the commencement of the study (Ref number: NHG DSRB: 2017/00185) in April 2017. All mothers who meet the inclusion criteria (EPDS≥9) will be given a set of participant information sheet consisting of a brief introduction, purpose, as well as the advantages and disadvantages of the study conveyed clearly. A written informed consent will be obtained from mothers who agree to participate. The participants are guaranteed anonymity and are informed of their right to withdraw at any point without affecting the subsequent care received. A token of appreciation will be given to all participants.
Phase 1 of the study has been completed. The peer volunteer manual has been developed, and peer volunteers have been trained. For phase 2, the recruitment of study participants was commenced in July 2017 and is still ongoing. The targeted aim of recruiting 118 mothers will continue for a year. Thus far, a total of 909 participants have been approached and 542 were screened (including those not interested and EPDS score of less than 9). The current sample size to date is 73 mothers (for both the intervention [n=37] and control [n=36] groups). The projected timeline for the completion of data entry and analysis for investigating the effectiveness of the technology-based peer support intervention program to prevent postnatal depression is around May 2019.
Previous local [
We hope to assess the effectiveness of this peer support intervention program. Optimistically, if the program is effective, it can then be implemented by health care professionals to aid at-risk mothers and reduce the prevalence of postnatal depression. This intervention program may not only be able to introduce a positive parenting experience to new mothers but may also mitigate the adverse psychosocial effects that PND has on the individual, the family, and society in general.
To ensure treatment fidelity, peer volunteers have undergone training to build rapport with their paired mothers, such as through daily text greetings and regular contact through mobile phone or email. Peer volunteers are also trained to contact and reply to the mothers quickly. On the other hand, constant messages and reminders are being sent to the peer volunteers by the research assistant to establish better rapport with them as well.
This study only recruits English-speaking Singaporean mothers, thus limiting its transferability to international settings. However, being set in a multiracial environment can increase international relevance. Additionally, due to practical reasons, the data collection is based on a self-report questionnaire, which is subject to response bias. Recruitment of peer mothers with prior history of postpartum depression also posed as a challenge due to the stigmatization of such mental illnesses in a conservative Asian society. Initial recruitment using posters was ineffective; therefore, recruitment of peer volunteers was mainly done through word of mouth. Despite these challenges and limitations, similar intervention methods in other studies have been shown to be effective.
analysis of covariance
analysis of variance
Edinburg Postnatal Depression Scale
Growing Up in Singapore towards Health Outcomes
International Business Machines Statistical Package for the Social Sciences
International Monetary Fund
National Health Group Domain Specific Review Board
Patient Health Questionnaire
postnatal depression
perceived social support for parenting
State Trait Anxiety Inventory
University of California, Los Angeles
World Health Organization
The authors express their thanks to the National University Health System for Collaborative Clinician Research grant (Ref number: T1- NUHS O-CRG 2016 Oct. 22). The authors also extend special thanks to the Medical Publications Support Unit of the National University Health System for their assistance in the language editing of this manuscript.
None declared.