Starting Before Birth to Prevent Maternal Mental Health Problems: "Parents and Babies" Program (Programme "Toi, Moi, Bébé")
Phase: NA
Conditions: Depression, Postpartum
Sponsor: St. Justine's Hospital

RESEARCH PROJECT
OFFICIAL TITLE : STARTING BEFORE BIRTH TO PREVENT MATERNAL MENTAL HEALTH PROBLEMS:
“PARENTS AND BABIES” PROGRAM (PROGRAMME “TOI, MOI, BÉBÉ”)
THE DATE ON WHICH THE UPLOADED DOCUMENT WAS APPROVED BY A HUMAN SUBJECTS
PROTECTION REVIEW BOARD: 2021-09-28
NCT ID NOT YET ASSIGNED
2021-09-28

RESEARCH PROJECT 
Starting before birth to prevent maternal mental health problems:
“Parents and Babies” program (Programme “Toi, Moi, Bébé”)
PRINCIPAL INVESTIGATOR:
Dre Sylvana Côté: Overall trial management and proper intervention implementation
514-865-2231
Sylvana.cote.1@umontreal.ca
CO-INVESTIGATORS/COLLABORATORS:
1. Dr. Cindy-Lee Dennis, Professor, Faculty of Nursing and the Faculty of Medicine,
University of Toronto: Expert in randomized controlled trial in the perinatal
population. She is advisor for the substantive, methodological, and logistic aspects of
the design and execution of the study.
2. Dr Benoit Mâsse, Professor, School of Public Health, University of Montreal: Senior
biostatistician and expert in clinical trial design and data management analysis. He is
Director of the Applied Clinical Research Unit (URCA) and will oversee all statistical
aspects of this trial.
3. Dr. Anick Bérard, Professor, Faculty of Pharmacy, University of Montreal:
Epidemiologist with extensive experience in maternal depression and conducting
studies using data linkage and social media recruitment. She will work with the NPIs
to oversee recruitment and linkage.
4. Dr. Catherine Haeck: Economist responsible for the economic evaluation.
5. Dr Lucie Morin, Chief Obstetric at the CHU Sainte-Justine: Provides administrative
and logistical support for the realization of the trial at the CHU Sainte-Justine.
Oversees the safety procedures together with Dr Amirali and Saint-André,
6. Drs. Martin Saint André, Medical Chief of the Pediatric Psychiatry Clinic, CHU
Sainte-Justine: Perinatal psychiatrist involved in the design and monitoring of the
intervention. Together with Tina Montreuil and Lila Amirali, they have produced the
intervention material and conceptualized the trial. They will provide training and
supervision, building on their extensive clinical expertise, and will be heading the
knowledge transfer plan to the clinical community.
7. Dr. Tina Montreuil, Assistant Professor, Department of Educational and Counselling
Psychology, McGill University: Psychologist involved in the design and monitoring
of the intervention.
8. Dr. Lila Amirali, Chief of the Psychiatry Department, CHU Sainte-Justine:
Psychiatrist involved in the design and monitoring of the intervention.
9.
Dr. Isabelle Boucoiran, gynecologist, CHU Sainte-Justine: Involved in the design of
the intervention.
10. Dr Kieran O’Donnell, Professor, Department of Psychiatry, McGill University:
Expert in observational   studies on perinatal mental health. Involved in the design of
the intervention and the conceptualization of the research trial.
11. Dr. Catherine Herba, Professor, Psychology Faculty, UQAM: Involved in the design
of the intervention and the conceptualization of the research trial.
12. Dr. Linda Booij, Professor, Department of Psychology, University Concordia:
Involved in the design of the intervention and the conceptualization of the research
trial.
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13. Dr. Tuong-Vi Nguyen, M.D., Assistant Professor, McGill University: Involved in the
design of the intervention and the conceptualization of the research trial.
14. Mrs. Julie Béland, Clinical Nurse Counsellor, CHU Sainte-Justine: Involved in the
design, coordination and implementation of the intervention.
15. Mrs, Valérie Samson, Clinical Nurse Counsellor, CHU Sainte-Justine: Involved in the
coordination and the implementation of the pilot study.
16. Mrs. Myriam Clement, PhD Student, School of Public Health, University of
Montreal: Involved in the design, coordination and implementation of the
intervention.
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Contents
Figures
4
Context
5
Research Questions
7
Method
7
Design
7
Population
8
Pregnant Women Recruitment
8
Partners Recruitment
9
Planned recruitment rate
9
Participating centers.
9
Sample
12
Description of “ Parents and Babies” (« Toi, Moi, Bébé ») intervention
13
Data Collection
15
Planned Analyses
17
Pilot Study
18
Ethical considerations
18
Voluntary informed consent
18
Confidentiality and Privacy Protection
18
Risks to Participants
19
Expected Results and Benefits
19
Timeline
20
Références
22
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Figures
Figure 1. Trial design
8
Figure 2. Schedule of recruitment and intervention implementation
10
Figure 3. Frequency and duration of the follow-up
15
Figure 4. Study timeline
20
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Context
During pregnancy and the postpartum period, women are at heightened risk of mental
health problems, with 1/5 experiencing moderate to high levels of depressive symptoms (1,
2). Perinatal mental health problems often go unrecognized and undiagnosed (3), with fewer
than 20% of symptomatic women receiving treatment (4). The cost of untreated maternal
depression is estimated at over $17,000 US per mother per year over the first five years of the
child’s life. In comparison, gestational diabetes costs up to $3,300 per mother and occurs only
during pregnancy (5). The consequences of untreated perinatal mood disorders include
maternal psychological, social, occupational, and physical dysfunction (1, 2).
About 20-25% of pregnant women have subclinical levels of depression (Edinburgh
Postnatal Depression Scale (EPDS) score 9-12) and 2/3 of these will go on to clinical
postpartum depression (EPDS > 13) (6-8). Though ineligible for publicly funded clinical
services, these women have poorer parenting/offspring outcomes (6). Fifteen meta-analyses
(300+ studies) have documented associations between maternal depression and poor
cognitive, behavioral, and emotional outcomes in the offspring, starting at birth and
extending into adolescence (9-18). Preventive interventions and childhood assessments could
inform the putatively causal role of maternal mental health on child development. In this
study, we test an early pregnancy intervention and its impact on postpartum ages 3 and 6
months. The virtual or remote format of the intervention (online and telephone) is designed to
overcome long-standing mental health management barriers.
Prevention of Postpartum Issues
There is growing evidence that the societal burden of perinatal mental health issues
can be prevented. Most women with postpartum depression have symptoms during pregnancy
(19, 20). High-risk women may be identified by simple screening (e.g., mobile phone) and
EPDS (21), and prevention programs in person or in groups are effective (2). Recognizing
potential for early prevention, the United States Preventive Services Task Force (2019) issued
a level B recommendation “that clinicians provide or refer people who are at increased risk of
perinatal depression to counseling interventions.” These include cognitive behavioral therapy
(CBT) and interpersonal counseling, such as the existing, evidence-based Mothers & Babies
program (22-25).
One important advantage of psychosocial support initiated before birth among
high-risk women is reducing the allostatic load, or the wear and tear on the body, generated
by stress and mental health symptoms. Allostatic load increases as pregnant women prepare
themselves for the heavy emotional and physical demands of giving birth and parenting (26).
In Canada, we lack a comprehensive perinatal prevention mental health framework. Existing
research and policy have focused on postpartum depression; we have not addressed
prevention in the antenatal period.
Efficacy of Virtual Interventions
Counseling is the treatment of choice for pregnant women with moderate levels of
depression. Evidence suggests effectiveness and no documented risks (2). Importantly,
evidence is low for the efficacy of antidepressant drugs in pregnant women when used as sole
treatment for moderate levels of depression. Further, a number of studies have raised
concerns about the potential risks of fetal exposure to antidepressants (27-33). Despite the
fact that women prefer counseling over medication (34), fewer than 20% of women with
perinatal depression receive counseling (4).
Barriers to counseling include lack of accessible and affordable programs (35), stigma
related to mental health problems (36, 37), cost and time constraints related to transportation
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to appointments, challenges of finding childcare while attending treatment (37), and
geographical barriers in under-served rural or socioeconomically disadvantaged areas (34).
Since the start of the COVID-19 pandemic in March 2020, social distancing, mandatory
mask-wearing, and other public health measures have added to the complexities of in-person
treatment, while the rates of depression in pregnant women have increased 2-3 fold (38, 39).
There is a pressing need for evidence of the efficacy of remote prevention and treatment
modalities.
Remote, or virtual, care is a promising solution to long-standing barriers to effective
management of perinatal mental disorders (34). Virtual care is defined as any interaction
occurring between patients and health care professionals using communication technology.
Previous studies have also suggested that patients and clinicians are satisfied with virtual
modalities (including psychiatric treatment by telephone) and that remote therapy can lead to
improved clinical outcomes (40). Almost 80% of pregnant women would consider
computer-based applications, because the material is accessible anytime, anywhere, no trip to
a therapist’s office is required, and feelings are more comfortably reported in a virtual setting
(41). Women of reproductive age commonly use the internet, social media, and smartphone
apps. There is accumulated evidence of the effectiveness of digital intervention in this
population (34, 42). Importantly, qualitative data from our pilot study showed high levels of
acceptability and satisfaction to virtual care and interventions (Appendix A).
There is, however, a paucity of studies providing evidence for the effectiveness of
antenatal virtual prevention programs for postpartum issues. A systematic review including 4
randomized controlled trials (RCTs) for the digital treatment of postpartum depression
identified small-to-medium effect sizes (43), but none of these interventions were initiated
during pregnancy (43, 44). In another small RCT conducted in pregnancy (n = 42), Forsell et
al. (2017) found that participants who received pregnancy-adapted internet-based CBT had
reduced rates of clinical depression after the 10-week intervention. In one large Norwegian
trial (n = 1342), Haga et al. (2019)
showed the efficacy of internet-based CBT for maternal
depression up to 6 weeks after birth. This impact, however, was not maintained at the 3- and
6-month follow-up. Loss of effect may be explained by high attrition rates related to the fully
automated format (no personal contact). It is important to note that virtual interventions with
personal (e.g., telephone, text, email) contact have higher retention rates than those without
(34), underlining the need for individual support in addition to a web-based modality. In our
pilot project, telephone follow-up was rated as “essential” in 40% of cases and “very useful"
in 40% of cases. To summarize, there is preliminary evidence suggesting that virtual
interventions during pregnancy may be effective in preventing postpartum depression.
However, we need data on longer-term effectiveness using larger samples of women most
at-risk of postpartum depression, i.e., those with subclinical to moderate levels of depression
in pregnancy.
Partner-Inclusive Intervention
Previous studies for the prevention of maternal depression have not explicitly
included the partner. Yet perceived lack of partner support is strongly associated with
maternal stress (45) and depressive symptom severity (46). Several recommendations have
been made to improve the level of couple satisfaction and reciprocal support (47) but few
studies targeting perinatal maternal depression have included partners. In one notable
exception, a study in China showed that CBT for couples was more effective in reducing the
incidence of postpartum depression than maternal therapy alone (48). Given the importance
of partners in maternal mental health, greater consideration should be given to partner
well-being and the role they play in bolstering or aggravating perinatal depression (47).
Allocating more resources and introducing family-focused care with depression screening in
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early pregnancy is recognized as critical for both parents but rarely addressed (49). This trial
will test the efficacy of an intervention in which partners are encouraged to take part and
engage in sessions that are specifically designed for the mother-partner dyad.
Causal Role of Maternal Mental Health in Child Development
Studies showing associations between perinatal maternal health and child development
are summarized in 15 meta-analyses (17, 18). Small to moderate negative effect sizes are
reported in cognitive development and in internalizing and externalizing problems in
childhood, extending into adolescence (18). This body of research is based on correlational
association studies, and as such, precludes any conclusion about the causal role of maternal
depression in child development. RCTs on the treatment of maternal mental health problems
seldom assess the impact on the child. This knowledge, however, is crucial to developing
preventive interventions to be implemented early in pregnancy. Pediatricians and child
development specialists need to know whether addressing early (subclinical) maternal mental
health issues in pregnancy is a strategy that can benefit children long-term. The putative role
of maternal mental health in child development can be evaluated in clinical trials that include
child outcomes for sufficiently long follow-ups.
Research Questions
Primary research question: Compared to a fully automated virtual (with a workbook
or online material) intervention, what is the effect of the virtual intervention with telephone
support for pregnant women with subclinical depressive symptoms on maternal depression at
3 months’ postpartum? We adopted an indicated prevention strategy (targeted or secondary
prevention), targeting women with symptoms of depression during pregnancy.
Secondary research questions: Compared to a fully automated virtual (with a
workbook or online material) intervention, what is the effect of the virtual intervention with
telephone support on: 1) maternal depression at 6 months’ postpartum; 2) maternal anxiety,
perceived stress, well-being, self-efficacy, self-compassion, sleep quality, tobacco, alcohol
and drug usage, social functioning, social support, marital satisfaction, co-parenting and
parental cognitions and practices, at 3 and 6 months’ postpartum; 3) child’s socioemotional
development at ages 3 and 6 months; 4) maternal health care services utilization at 6 months’
postpartum.
Tertiary research questions: What is the effect of a virtual intervention (with a
workbook or online material) + telephone support on 1) partner depression, anxiety,
perceived stress, well-being, self-efficacy, self-compassion, sleep quality, tobacco, alcohol
and drug usage, social functioning, social support, marital satisfaction, co-parenting and
parental cognitions and practices, at 3 and 6 months’ postpartum; 2) What are the moderators
of the effect (e.g., compliance to the intervention, COVID-19 infection of self or relatives,
personality disorder traits, socioeconomic level, ethnicity, gender at the baseline, and sex of
the child).
Method
Design
A randomized controlled trial (RCT) of 500 Quebec women with a 1:1 assignment to
either virtual preventive intervention with telephone support or without telephone support
(control). Figure 1 presents the trial design.
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Population
French-speaking pregnant women older than 14 years old, with subclinical levels of
depression (EPSD 9-12).
Figure 1. Trial design
Pregnant Women Recruitment
Pregnant women will be recruited via three possible means: 1) Recruitment posters
and pamphlets (Appendix B, Recruitment poster and pamphlet) distributed in clinics
associated with the CHU Ste Justine; 2) Obstetrician, psychiatrists or general practitioner in
clinics associated with the CHU Ste Justine ; or 3) Advertisements posted on various social
media (Facebook, Instagram; Twitter, etc.). Interested women will either 1) connect to a web
page and fill a contact form (Appendix C); or 2) contact us by phone, text message or email.
The research coordinator will contact women referred by practitioners or through
advertisement. The study will be explained and a consent form (Appendix F, Consent forms)
will then be sent through REDCap. Participants will sign virtually. Then, they will respond by
telephone to the eligibility questionnaire (5 min.), including the EPDS (50) psychosis
screening questionnaire and self reported substance abuse problem. Those with subclinical
levels of depression (EPDS 9-12) and without psychosis and substance abuse problem will be
randomized via REDCap and informed of their group allocation.
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Partners Recruitment
During the recruitment phone call with pregnant women, the research coordinator will
explain the possibility of partners to participate in the study and the advantage of it. A partner
can be the spouse or any other significant person who will accompany the pregnant woman
during pregnancy and after childbirth. It is recommended to keep the same person for the
duration of the course. The research coordinator will ask the pregnant women to identify her
partner and if he or she is at home at this moment, he or she will be invited to join the call.
Partners will be eligible only if the pregnant woman signed the consent form and is eligible
for the study. If the partner is absent, the research coordinator will ask for his or her email or
telephone number. If the pregnant woman sign the consent form and is eligible for the study,
an invitation will be sent to briefly explain the project and to ask them if they accept us to call
them to give more information and recruit them if interested. The research coordinator will
then contact those interested, explain the study and send an email with the consent form.
Recruited pregnant women and partners will receive a notification with a link to answer the
baseline questionnaire (Appendix E, Baseline and follow-up questionnaires) online and our
contact information to take an appointment with a research assistant if they prefer to answer
the questionnaire on the phone. After completion of the baseline questionnaire, access to the
intervention website will be authorized.
Planned recruitment rate
The participant recruitment rate depends on two factors: 1) capacity to recruit pregnant
women with subclinical depressive symptoms (EPDS 9-12); 2) participant acceptance of the
trial. In one of our ongoing mental health studies in pregnant women, 374 (22.1%)
participants with EPDS scores 9-12 (out of 1695 assessed) were recruited over social media
in a two-week period (i.e., 185/week). Within Sainte Justine’s obstetrics clinics, 25 – 30
women/week are assessed with the EPDS. Therefore, we expect to recruit around five
women/week at the beginning of our trial. When we will expand our recruitment on social
media, we estimate to recruit n = 15 women per week willing to accept randomization. The
recruitment period should last a total of approximately ten months. Thus, an average of 25
women per month would enter the intervention under the guidance of one of 3 coaches (i.e., 8
women/coach). Intervention activities will take 18-20 months. Figure 2 presents the schedule
of recruitment and intervention implementation.
Participating centers.
The trial is based at Sainte Justine Hospital (CHU Ste-Justine), the largest mother-child
hospital in Quebec. Affiliated obstetric clinics will refer patients to the study site (Appendix
G, Letters of Support). These clinics provide an ideal setting for recruiting mothers of diverse
ethnic backgrounds.
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Figure 2. Schedule of recruitment and intervention implementation
1 First women to complete will begin the trial at 25 gestational weeks in the first wave of recruitment
2 Last women to complete will begin the trial at 12 gestational weeks in the last wave of recruitment
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Sample
We followed the USPSTF recommendation for the prevention of postpartum
depression (2) by targeting pregnant women with moderate depressive symptoms, who could
reasonably be considered as signaling distress or early signs of illness, are at high risk for
postpartum depression, and are not eligible for specialized psychiatric care. Our program is a
virtual and population-based preventive intervention, not a treatment for clinical depression,
although it could reasonably be conceived as an adjuvant to psychiatric care.
Pregnant women inclusion criteria: Pregnant women (12-25 weeks’ gestation), ages
14 years or older, with: 1) subclinical levels of depression (EPDS scores 9-12) and 2) ability
to read and understand French.
Pregnant women exclusion criteria: 1) EPDS score in the clinical range (≥13) or no
symptoms (EPDS < 9); 2) Positive screening of psychotic symptoms using the Psychosis
Screening Questionnaire (PSQ); 3) self-reported substance abuse problems. These criteria are
consistent with those of other prevention trials (51).
Partners inclusion criteria: 1) The spouse or any other significant person who will
accompany the pregnant woman during pregnancy and after childbirth, chosen by the
pregnant woman. 2) The pregnant woman has consented to participate in the study.
Participant allocation. Randomization will be centrally controlled by the CHU
Ste-Justine Applied Clinical Research Unit (URCA), headed by co-PI Benoît Mâsse. An
independent biostatistician will create the randomization scheme, a computer-generated
random listing using a 1:1 allocation, according to trial statistician instructions. Random
permuted blocks randomization will be used. The randomization list will be WEB-based and
completed via REDCap.
Bias protection. With detailed informed consent procedures, it is expected that
pregnant women will accept their randomized group allocation. The intervention team will be
blinded to the initial level of depressive symptoms. No formal virtual depression prevention
intervention program yet exists in Quebec. There will be no interference with usual
medical/nursing care, which may include antidepressant medication and/or psychotherapy.
Sample size. A meta-analysis of 58 studies indicates that the overall prevalence of
postpartum depression is 17% (95% CI: 0.15–0.20) (53). This estimate falls within previously
published estimates of 13%–19.2% (54, 55) and is similar to Hahn-Holbrook’s 2018 finding
of 17.7%. In-person interventions using the Mother & Babies course reported moderate effect
sizes (OR = 0.28 (0.08-0.94) (22) and OR = 0.45 (0.19-1.10) (24)). Fully web-based without
nurse-based telephone support reported small to moderate effect sizes (40). Given that the
proposed intervention is offered virtually with nurse-based telephone support, we calculated a
sample size that allows us to detect a moderate decrease in rates of clinical depression. We
anticipate that 20% of pregnant women in the control group will have an EPDS score ≥13 at
postpartum. A total of 500 pregnant women (250 per arm) is needed to detect an absolute
reduction of 10% (i.e., 20% of women with EPDS ≥13 in the control arm versus 10% in the
intervention arm) with 80% of power and a 2-tailed alpha of 5%. The sample size includes an
attrition rate of 10% for 3 months’ postpartum and another 10% between 3 and 6 months’
postpartum. Based on our experience with pregnant women and the intervention (see Section
about Pilot Study), the 10% attrition estimate is conservative. As most of the secondary
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outcomes are continuous, the sample size provides enough power to detect small to moderate
effect sizes using a 2-tailed alpha of 1% to account for multiple tests.
Compliance. We conducted a feasibility pilot study including 17 pregnant women.
All began to read the online material and 2 refused further participation after 2 telephone
calls, a dropout rate of 11.7%. We therefore expect that 80-90% of the intervention group will
read at least some of the intervention material. Intervention compliance will be defined as
completion of a minimum of 6/8 online modules and 6/10 telephone follow-ups. Compliance
will be monitored automatically online and by nurses during telephone calls. Weekly text
reminders will be sent out to maximize compliance (see details in Appendix H).
Loss to follow up. The following proactive telephone strategies will be employed to
encourage retention. Each computer-based questionnaire will contain a contact form for the
research nurse to record the date, time of the call, the status of calls (busy, call back, no
answer, etc.), email address, name and contact information of the partner and of one
additional reference person (e.g., family member). Participants will be telephoned during
their stated “best time to contact” period. Congratulations cards will be sent at the birth of the
child, showing contact information for the study. Participants will be invited to go to the
study Facebook page, with periodic lotteries of gift certificates. Additional strategies to
ensure a high retention rate, based on a Cochrane review (56), include card pre-notification of
impending interview and a small token of appreciation for each assessment completed. All
these strategies have been successfully used in Dennis’ postpartum depression prevention
trial with good results (retention rate = 87% of the 12-week assessment and 85% of the
24-week assessment).
Description of “ Parents and Babies” (« Toi, Moi, Bébé ») intervention
The Parents & Babies intervention to be evaluated is an adaptation of the existing,
evidence-based Mothers & Babies program (see Authorship Rights, Appendix I), which has
shown efficacy in four clinical trials for the prevention of postpartum depression through
in-person (group or individual) counseling (22-25). In a study with a low uptake of the
intervention, a Spanish web-based format without telephone contact was tested and suggested
some impact on women with moderately high levels of depression (57).
The Parents & Babies program was adapted to be virtual and include: 1) specific
modules for the mother-partner dyad; 2) third-wave cognitive behavioral therapy (CBT)
strategies targeting well-being, relaxation, mindfulness, self-compassion, and gratitude; 3)
confinement and social distancing related material. Participants follow the program online or
with a paper workbook and are called weekly by a member of the intervention team. We
started a pilot study in July 2020 (n=17) to examine the feasibility and acceptability and
results thus far suggest high satisfaction and compliance (Appendix A). We tested assessment
protocols within two maternal mental health observational studies across Canada led by our
co-applicants (58, 59). We therefore have the capacity to set up the larger proposed trial
within an efficient timeframe and to implement within one month after the Ethics Committee
approval.
The Parents & Babies intervention consists of 1) a self-help web-based platform and
workbook of 10 modules offering CBT intervention and exercises; and 2) 10 telephone
counseling calls by trained coaches: 9 during pregnancy (one call/week) and 1 at 6 weeks
postpartum. Each web module takes 10-20 minutes online; one module per 1 or 2 weeks is
advised. The program focuses on pleasant and rewarding activities, recognizing and
distinguishing between harmful and beneficial thoughts, reducing cognitive distortions and
automatic thoughts, encouraging social networking and healthy communication, promotion of
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a positive coparenting relationship and mother-child attachment (See Appendix J for access
to the intervention website). Further, it proposes relaxation and mindfulness exercises. We
have included individual telephone calls by a trained coaches aimed to: 1) encourage the use
of online material; 2) identify strategies for overcoming obstacles; 3) help apply content to
real-life settings; and 4) underscore the participants’ success in using effective coping
strategies (see Appendix K, Coaching phone calls guide).
Partner participation. Women are encouraged to involve their partner if they feel it
is appropriate. Partners are invited to specific modules.
Duration of treatment period. The typical duration of the program is 2 months (8
weeks) during pregnancy and 2 months over the first 3 months of the baby’s life. The two
postpartum sessions aim to lend support during the challenges of the postpartum period. The
proposed frequency of nurse telephone follow-up is once/week in pregnancy and once/month
in postpartum, but this can be adapted to the needs of the woman and/or her partner. Figure 3
presents the intervention and assessments.
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Figure 3. Frequency and duration of the follow-up
Participants will fill out questionnaires (online or by telephone) at T0 (12-25 weeks’
gestation), T1 (3 months’ postpartum), and T 2 (6-months postpartum) to assess baseline
values and trial outcomes, respectively. If we show efficacy at 3 months’ postpartum (primary
outcome), we will seek funding to follow families over the early childhood years. Real date
of birth will be assessed six weeks after the estimated date of birth.
Coaches training and supervision. PhD students in clinical psychology and Master’s
students in nursing are ideally suited to conduct the 10 follow-up calls. They will be
supervised by our multidisciplinary team (2 nurses, 2 clinical psychologists, and 2
psychiatrists). All coaches will receive 5-day training in perinatal mental health and use of
the intervention material. Procedures for calls will be outlined in the intervention manual.
The supervision team will oversee implementation as part of the Executive Committee.
Intervention sessions will be audiotaped and randomly reviewed by the supervision team to
ensure compliance with the material.
Virtual intervention without telephone support (control group). The control group
will receive a fully automated version of the virtual intervention
Data Collection
We will conduct a comprehensive assessment of perinatal maternal mental health and
functioning as well as factors that may modify the impact of the intervention. The chosen
assessment tools are validated (French and English), require low levels of literacy and take
only 15-30 minutes to complete (Appendix L, Description of assessment tools). They have
been used previously with pregnant women and examined for clarity, comprehension, and
ease of use. The questionnaires will be completed online via REDCap or over the telephone
with a research assistant blinded to group allocation depending on maternal preference, and
with the partner if the woman so chooses.
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Primary outcome. Maternal depression at 3 months’ postpartum was chosen as the
primary outcome to: 1) ensure comparability to other perinatal trials (60-67) and 2) to reduce
potential biases induced by attrition. The primary outcome will be the proportion of women
with EPDS scores above the clinical cut-off for depression (EPDS ≥13)). Differences
between experimental and control groups will be analyzed at T1 (3 months’ postpartum) and
again at T2 (6 months’ postpartum, secondary outcomes). The EPDS is an internationally
recommended 10-item self-report scale that assesses depressive symptoms on a 4-point scale;
scores range from 0 to 30 with higher scores representing higher symptomatology. More than
80% of perinatal depression studies use self-report measures (73) and the majority use the
EPDS. The EPDS was created to counter the limitations of other well-established depression
scales when used during the perinatal period. It has been validated by standardized
psychiatric interviews with large sample sizes and has well-documented reliability and
validity of over 11 languages (50, 74). Participants will fill out the EPDS at 3 assessment
times: baseline (T0, as part of inclusion criterion), T1, and T2.
Secondary outcomes. Participant and partner assessments at baseline, T1 and T2.
The proposed intervention is based on CBT principles used to treat both anxiety and
depression. As anxiety is highly correlated with perinatal depression, it is an important
secondary outcome. Generalized anxiety. The proposed intervention is based on CBT
principles used to treat both anxiety and depression. As anxiety is highly correlated with
perinatal depression, it is an important secondary outcome. Anxiety will be assessed at all 3
time points, using the Generalized Anxiety Disorder 7-item (GAD-7) scale, an extensively
validated self-report instrument (75-77). Anxiety related to pregnancy will be measured with
the 10-item Pregnancy-specific anxiety scale (PRAQ-R2) (78, 79) at baseline. Stress will be
assessed using the 10-item form of the Perceived Stress Scale, at six months postpartum (80,
81). Well Being will be evaluated with the 5-item WHO-5 well-being index at T1 (82).
Self-efficacy will be assessed using the 10-item General Self-Efficacy Scale (GSE) at 3
months postpartum (83, 84). Self-Compassion will be measured with the 12-item shortened
version of the Self-Compassion Scale (SCS) (85-87), at 3 months postpartum. Sleep. Sleep
may improve as a result of the increased capacity for relaxation, mindfulness, and emotional
regulation fostered by the intervention. At 3 months postpartum, we will assess sleep quality,
a critical aspect of perinatal maternal health, using the 19-item Pittsburgh Sleep Quality Index
(PSQI) (88, 89), a self-report over a one-month interval with very good psychometric
properties and validated for use during postpartum (90). Tobacco, alcohol and drug use will
be self-reported at baseline and 3 months postpartum. Social Adjustment will be assessed
using the 14‐item screener version of the Social Adjustment Scale – Self-report (SAS‐SR)
(91, 92). Six major areas are covered: work (paid or unpaid), social and leisure activities,
relationships with extended family, role as marital partner, role as a parent, and role within
the family unit (including perceptions about economic functioning). For this study, we will
only use the work subscale at 3 months postpartum. Marital satisfaction will be evaluated
with the short version of the Dyadic Adjustment Scale (DAS-7) (93-95) at 3 months
postpartum. Co-parenting. The proposed intervention is partner-inclusive and, as such, may
improve co-parenting quality (the extent to which parents work together and agree on
childcare and education). We will use a brief 14-item version of the Coparenting Relationship
Scale (75) (e.g., partner pays a great deal of attention to our child; partner appreciates how
hard I work at being a good parent) at 3 months postpartum. Social Support will be assessed
at 6 months postpartum using the 10-item Social Provisions Scale (SPS-10) on emotional
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support or attachment, social integration, reassurance of worth, tangible help, orientation, and
opportunity for nurturance (96, 97).
Parent and child assessments. Maternal depression has repeatedly been associated
with
poorer
quality
mother-infant
relationships,
attachment,
and
child-emotional
development. Parenting will be assessed at 6 months postpartum with the Parent's Cognition
and Conduct Toward the Infant Scale (ÉCOPAN) (98). Child social, emotional and cognitive
development. The Ages and Stages Questionnaire 3rd edition (ASQ-3) is a widely used
parent-reported scale covering physical, social, emotional, and cognitive child development
at ages one month to 5 ½ years. Its parent-centric approach and inherent ease of use have
made it the most widely used developmental screener in the world (99). Child difficult
temper
will
be
evaluated at 6 months postpartum with the Infant Characteristics
Questionnaire (ICQ) (100, 101).
Other variables (effect modifiers). Compliance to the intervention. Participant and
partner use will be calculated automatically using web-based statistics and the number of
modules completed will be self-reported.The number of calls with the nurses will also be
recorded. Intervention Team Activity Log. All intervention activities (telephone discussions,
voice messages, missed sessions) will be documented. Personality disorders symptoms.
These may be important modifiers of the intervention and thereby impact compliance. We
will use the 25-item Personality Inventory for DSM-5 Brief Form (PID-5 BF) (102). Groups
will be created using a 30% cut-off score for each subscale. Gender roles. Using data at T2we
will create a gender role score for participants and partners by identifying gender-related
variables such as employment status, income; gender roles assessed using the Bem Sex Role
Inventory (BSRI) (103, 104). Sex of the child will also be tested as a potential effect
modifier. The sociodemographic and medical history. Information will be collected about
the household, employment status, revenue, education level, ethnicity, reproductive history,
COVID-19 infection history and weight.
Economic evaluation. Service utilization will be measured using a slightly modified
version of the Health Service Utilization and Cost of Care Questionnaire (105) to assess
childcare expenses and travel costs incurred by patients to obtain care. Costs of administering
the intervention include a) recruiting and training of nurses, b) nurses’ time to provide the
intervention, and c) supervision of nurses.
Planned Analyses
Data will be analyzed using SAS software using an intent-to-treat approach. A
two-sided significance level of 0.05 will be used for the primary outcome; a significance
level of 0.01 (two-sided) will be used for secondary and other outcomes to account for
multiple outcomes. Demographic and other baseline variables will be compared between
study groups using descriptive statistics (mean, standard deviation, proportions).
For the primary outcome, a two-sample sided test of proportion (chi-square test) will
be used to compare the difference in the proportion of women with EPDS in the clinical
range (> 13) at 3 months’ postpartum. The same approach will be used for the 6-month
assessment (secondary outcome). These analyses will be supplemented by an analysis using
EPDS scores, where the baseline EPDS score will be used as covariate in an ANCOVA
model including the 3- and 6-month EPDS scores. With this model, we will obtain 95%
confidence intervals of EPDS score differences between intervention arms at 3 and 6 months’
postpartum. Sensitivity analyses will be performed to investigate the potential bias introduced
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by attrition. A method based on inverse-probability-of-attrition weights (IPAWs) will be used
(101, 102).
For secondary outcomes, the statistical method for comparing intervention arms will
depend on the distribution of the outcome variable. For binary variables, chi-square tests will
be used. The corresponding 95% CI for the difference in proportions will also be provided. In
the unlikely event that randomized intervention arms are unbalanced for baseline variables
known to be associated with primary and secondary outcomes, logistic regression will be
used where unbalanced variables will be included. For continuous variables, we will use
ANCOVA models as described above. Again, unbalanced variables will be added if needed.
If the intervention is found to be effective, exploratory analyses will be conducted to explore
the potential effect of moderator variables using causal inference models including gender
and intervention compliance (103, 104). No formal interim efficacy analysis is planned.
Ethical practices and conduct of the trial as well as all safety concerns will be reported to an
independent Data and Safety Monitoring Committee.
Planned subgroup analyses. The ANCOVA models presented above will be
expanded to include the socioeconomic status of the participant, ethnicity, personality
disorder symptoms subgroup variable as well as interaction with the intervention.
Pilot Study
We conducted a feasibility study to assess acceptability and compliance to the
intervention (n = 17). Pilot data indicate that women used a mix of electronic devices to
access the intervention. All used an iPad at some time, 40% also used their smartphone and
20% also used a computer. Telephone follow-up by a nurse was rated as “essential” (40%),
“very useful” (40%), or “useful” (20%). Online sessions were rated as “very useful” (60%) or
“useful” (40%). Strategies proposed in the intervention (cognitive restructuring, relaxation,
behavioral modification, social support) were used “regularly” (30%), “often” (50%),
“occasionally” (10%), or “never” (10%). The material was rated as “very easy to understand”
(90%) or “easy” (10%). Each strategy was used at least occasionally by 86% of women.
Qualitative data indicated high levels of appreciation (Appendix A).
Ethical considerations
Voluntary informed consent
The recruiting process will allow women to give a voluntary informed consent
(Appendix E). The consent form will be signed on the online platform provided by the
URCA.
Confidentiality and Privacy Protection
The trial manager will obtain signed confidentiality agreements from research
assistants. All baseline and outcome data will be collected via online questionnaires using
REDCap and stored in an anonymized database on a secure server at URCA. Data will
remain strictly confidential and will not be disclosed to members of our intervention team or
the partner. Data safety will be maximized through electronically protecting access to
computers and servers, use of fire walls. Coding standards will be developed by the executive
committee and communicated to the Data Management Committee (DMC) who will ensure
that confidentiality of data is ensured. The intervention coordinator and trial manager will
2021-09-28

also report to the DMC any adverse events arising from the interventions, including situations
in which additional interventions were required following disclosure of risk by a participant
or during an assessment or intervention session. Independent Data and Safety Monitoring
Committee (DSMC) will consist of experts not involved in the planning and conduct of this
study, with no conflicts of interest or obligations to the investigator. A database of adverse
events will be maintained by the DMC and annual reports will be sent to the Data and Safety
Management Committee (DSMC). At the end of the study, data will be transferred on the
University of Montreal’s server (UNIX) (see Appendix O for bank protocol).
Exercises responses stored on the website will be secured. None of the answers given
by participants will be analyzed as part of the study. These exercises are exclusively an
educational tool from the intervention. Professionals and partners will not have access to this
content.
The Parents and Babies program is a research project and is not part of the usual
services provided. Personal outcomes from the intervention will not have any clinical impact
that would require follow-up from the medical team. For this reason, participation will not be
indicated in the participants’ medical record. This intervention is validated in other
populations (American pregnant women in the general population) and formats (in person 1:1
or group session, fully automated web-based course).
Risks to Participants
Counseling interventions received a grade B recommendation from the USPSTF (2),
reflecting the low level of risk and high probability of a moderate net benefit. None of the
included studies, however, offered virtual counseling and there is very little evidence of the
efficacy of virtual prevention interventions. As in all studies where participants report on
their mental health, there is always the possibility that participants become more aware of
their symptoms. We will minimize risk to participants by taking the following measures.
First, at the end of each assessment, there will be a list of resources to manage mental health
issues (Appendix M). The list will include contact information for: 1) in Quebec, Integrated
University Health and Social Services Centres (CIUSS). These local community health
centers offer prenatal classes, telephone call services, and links to psychosocial and mental
health services; 2) family physician clinics; 3) obstetric clinics, and; 4) emergency phone
numbers and help lines. Second, we will set up a telephone line to answer questions about the
study and remind participants of available resources. Third, participants with a positive
response on the EPDS self-harm ideation item or scoring above the clinical EPDS cut-off (≥
13) during screening or follow-up will be notified by a pop-up at the end of the questionnaire.
The pop-up will inform them they will receive a phone call from a nurse of our team and
encourage them to speak to their doctor and contact resource links (Appendix N). The nurse
will make the call within 24 hours to evaluate the suicidal risk and make sure the participant
is taken in charge by appropriate health services.
Expected Results and Benefits
This project will 1) provide virtual support related to the program content to women
with symptoms of depression (moderate severity) in a context where individual medical and
psychosocial follow-ups are minimized due to the pandemic; 2) prevent the worsening of
depression and anxiety, improve stress management, and potentially improve obstetric
outcomes and prevent child development disorders associated with maternal disorders; 3)
develop an online economic intervention for pregnant women in situations of social isolation
or activity limitations due to various causes (e.g., pandemic, strict rest at home); 4) facilitate
the coordination of virtual social support by maternal and child physical health specialists and
2021-09-28

mental health specialists; 5) test a low-cost intervention with the potential to reduce third-line
mental health care costs and thus increase effectiveness in regular practice, and; 6) to promote
the evolution of interdisciplinary perinatal practices and to deepen the integration of perinatal
mental health practices into the Mother-child program at Sainte-Justine University Hospital.
Timeline
We plan to complete activities in 4 years, with 2 years allocated to intervention and
follow-up. Figure 4 presents details of the study timeline.
Figure 4. Study timeline
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2021-09-28

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