To evaluate the effectiveness of a web-based secondary prevention programme for postpartum depression, delivered with or without telephone support, compared with usual care.

We first conducted a randomised controlled superiority trial to test whether the web-based Parents and Babies programme (Toi, Moi, Bébé; TMB) delivered with motivational telephone support (ie, coaching) was superior to the fully automated programme (ie, self-help). TMB incorporated classic and third-wave cognitive–behavioural therapy components and psychoeducation. Then, we tested whether TMB (both treatment modalities combined) was superior to usual care. The usual care comparison group was drawn from the CONCEPTION prospective pan-Canadian perinatal cohort (N=592).

A remote study based at Sainte-Justine Hospital Centre, Quebec, Canada.

Web-based intervention programme participants were women aged ≥14 years at 12–25 weeks’ gestation, with subclinical to moderate clinical Edinburgh Postnatal Depression Scale (EPDS) scores: 9–16. Exclusion criteria were psychosis and self-reported substance abuse. The usual care comparison group was pregnant women ≥18 years old. All participants were living in Canada at study inception.

The primary outcome was EPDS scores at 3 months post partum, accounting for baseline EPDS scores and depression events defined as EPDS ≥13 at 3 months post partum. The secondary outcomes were EPDS scores at 6 months post partum, depression events (EPDS≥13) at 6 months post partum, anxiety symptoms (Generalised Anxiety Disorder 7-item Scale, GAD-7) at 3 and 6 months post partum, accounting for baseline scores for the continuous outcomes; as well as the number of completed intervention modules and well-being scores (WHO 5-Item Well-being Index) at 3 months post partum.

We randomised 510 participants to TMB self-help (n=255) or TMB with coaching (n=255); 211 and 214 participants, respectively, were included in the complete-case intention-to-treat analyses. At baseline, 91% lived with a partner, 71% were university graduates and 42% self-reported GAD-7≥10. Randomisation was successful. First, TMB with coaching was not superior to TMB self-help: at 3 months post partum, EPDS scores were TMB self-help (mean 8.0±4.3) vs TMB with coaching (mean 8.6±4.5); effect size was 0.01 (95% CI 0.00 to 0.03; p=0.16). Second, TMB (regardless of intervention arm) was superior to usual care: in adjusted regression models, EPDS scores were 6.2 units lower (per SD, 95% CI –8.2 to –4.3) in TMB (both treatment modalities combined) than in usual care; and proportions of depression events were 4.7 units lower (per SD on the logit scale, 95% CI –6.6 to –2.7) in TMB (combined) than in usual care. No other group differences were observed.

Our findings suggest that, in women with subclinical to moderate clinical antenatal depressive symptoms, receiving a web-based cognitive–behavioural therapy-based programme in addition to usual care can reduce depression postnatally.

NCT05110456.

Parental psychological challenges and poor well-being are key factors in shaping both the quality of parent-child interactions and child development. Specifically, maternal psychological distress is a central determinant of child development. Elevated levels of distress in mothers are associated with poorer child cognitive, behavioural and social-emotional outcomes, with effects persisting into adolescence and adulthood. While this highlights the critical importance of early prevention and intervention efforts to support parents, postpartum mental healthcare remains limited, despite ongoing and evident needs.

This protocol outlines a 2-year longitudinal follow-up study investigating the impact of a secondary perinatal programme (ie, Toi, Moi, Bébé), completed by mothers during pregnancy, and its impact on children’s cognitive and social-emotional functioning at 24 and 48 months. Further, the study aims to explore whether maternal self-efficacy and emotion regulation may serve as potential mediators or moderators of the relationship between programme participation and child development outcomes. The research aims to leverage the Toi, Moi, Bébé programme, by recruiting mother-child dyads (n=250) in which the mothers participated in the programme during pregnancy. Mothers were randomly assigned to complete the parenting well-being intervention either independently or with added telephone support. Participants who consent will be invited to take part in a two-wave follow-up at 24 months (T1) and 48 months postpartum (T2). At both time points, mothers will complete demographic questionnaires and standardised measures assessing maternal well-being (Generalised Anxiety Disorder-7, Edinburgh Postnatal Depression Scale and Perceived Stress Scale), child cognitive functioning (Ages and Stages Questionnaire-3 and MacArthur-Bates Communicative Development Inventory), child social-emotional functioning (Ages and Stages Questionnaire, Social Emotional—second Edition-2 and Child Behaviour Checklist for Ages 1.5–5), maternal emotion regulation (Cognitive Emotion Regulation Questionnaire) and maternal self-efficacy (Parental Cognitions and Conduct Towards the Infant Scale & Me as a Parent Scale). Parents’ perceptions of their parenting experience will be measured using the Parental Reflective Functioning Questionnaire. Mother-child interaction, parenting quality and cognitive stimulation in the home environment will be measured using a brief virtual interview (StimQ₂-Toddler) and a naturalistic observation assessment (Parenting Interactions with Children: Checklist of Observations Linked to Outcomes). Using RStudio, linear mixed models will be used to assess the impact of the intervention (online intervention only vs only with telephone support) on child cognitive and social-emotional development at T1 and T2. In parallel, separate models will be conducted to examine associations between maternal emotion regulation and self-efficacy on the child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine potential moderating effects of child sex and group assignment on the associations between maternal emotion regulation and self-efficacy and child developmental (cognitive and socioemotional) outcomes, using causal inference models.

The current study has been registered, reviewed and approved (MP-37-2025-10894) by the Research Institute of the McGill University Health Centre Research Ethics Board. Findings from this research will be disseminated through peer-reviewed open access publications, and presentations at national and international conferences.

NCT05110456.