From mother to child: a protocol paper on the longitudinal effects of a perinatal intervention on maternal self-efficacy and emotion regulation and child outcomes

Abstract

Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT05110456.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The study is a longitudinal follow-up, leveraging an existing maternal randomised-controlled intervention study, enhancing the feasibility of the child study follow-up (ie, recruitment, attrition, etc).

• The study employs a multi-method approach using validated questionnaires and standardised batteries to assess dimensions such as maternal IQ using the Wechsler Adult Intelligence Scale—Fourth Edition, and naturalistic observational data, providing comprehensive insight into parenting behaviours, child functioning and parent-child relationship quality.

• Conducting naturalistic observation sessions virtually rather than in-home may enhance feasibility by enabling participation from families who may live further away, while relying on in-lab observations or the absence of clinician-rated observational components may present greater limitations.

• Given the longitudinal nature of the study, ensuring retention over the course of the study may be challenging, and thus, attrition is possible due to the time elapsed between the end of the maternal study and the onset of the child follow-up study (>24 months).

• To our knowledge, this is the first study investigating how both parental emotion regulation and self-efficacy influence child developmental outcomes during early childhood.

Introduction

Parental psychological challenges have consistently been associated with less adaptive child behaviour and compromised cognitive development.1,4 Psychological distress in parents, particularly mothers, can undermine the quality of the parenting environment, leading to developmental difficulties and increased psychosocial challenges in children.3,5 Extensive research has further documented associations between maternal mental health difficulties and adverse cognitive, behavioural and social-emotional outcomes in children.^{1 2} These implications extend beyond the early stages of development, heightening the risk of long-term challenges across adolescence and adulthood, including job instability, mental health difficulties, legal and judicial issues, as well as interpersonal problems.^{3 6 7} This further highlights the critical need for early prevention and intervention support for parents. In this context, parent-focused interventions designed to support families through the transition to parenthood are particularly important, as this period involves navigating numerous stressors (ie, sleep disturbances, work-life balance, relationship issues and exhaustion⁸), and not all parents are equipped with the skills nor possess the emotional resources that support parents when navigating these parenting challenges effectively.

Moreover, emerging literature emphasises that the effects of maternal mood disturbances are shaped by broader social determinants, including poverty, immigration status and racialised stress^{9 10} further reinforcing the need for a population health lens. Early identification of at-risk mother-infant dyads, coupled with sustained support during the postnatal period, may buffer adverse outcomes and promote resilience.^{11 12}

Maternal psychological challenges and child outcomes

Belsky’s Process Model of Child Development⁵ emphasises that parenting is shaped by a range of factors, including parent and child individual variables, as well as the broader social context (eg, social support) in which the parent-child relationship is embedded. Belsky’s model highlights how these factors influence parental behaviours, which in turn affect parenting outcomes and ultimately shape child development.

Research has shown that mothers who experience emotional and psychological distress during pregnancy are more likely to experience emotional vulnerability and/or parenting stress at three and 6 months postpartum.13,16 These ongoing difficulties during the postpartum period are associated with greater challenges in parenting and in creating a secure, nurturing and supportive family environment, compared with those without such distress.^{7 17} In turn, these challenges can influence child-rearing practices and adversely impact child developmental outcomes. Although the risks associated with the postpartum period are well-documented, research on sustained mental healthcare beyond the early weeks following birth remains limited, underscoring the urgent need to provide ongoing care for women during this vulnerable time.^{18 19} Emerging evidence also underscores the importance of maternal cognitive ability, such as IQ, as a strong predictor of child development, particularly in cognitive domains.²⁰ Moreover, maternal IQ may confound the relationship between perinatal symptoms of depression and child developmental outcomes, highlighting its critical role in shaping early child development.²⁰ It is therefore essential to identify key parental factors to inform targeted prevention and early intervention efforts that support parental well-being and, in turn, foster positive child development outcomes throughout the postpartum period.

Maternal psychosocial factors and child outcomes

Self-efficacy

Parental self-efficacy reflects parents’ beliefs in their ability to shape their child’s environment in ways that promote development and success.21,24 High parental self-efficacy enables parents to guide their children effectively through developmental struggles, whereas low parental self-efficacy may contribute to increased stress and a greater risk of psychological distress.2124,26 Evidence of this can be observed in preliminary findings from Toi, Moi, Bébé (TMB), a randomised controlled trial (RCT) launched during the COVID-19 pandemic. The online intervention is comprised of 10 modules aimed at promoting mental health and well-being among current and future parents. Mothers were randomly assigned to complete the modules independently (TMB online) or with the support of weekly telephone coaching from a trained professional (TMB-coaching; with online). Of the 510 participants randomised to TMB (n=255) or TMB-coaching (n=255), 211 and 214 were respectively included in complete-case intention-to-treat analyses. At 3 months’ postpartum, preliminary results revealed that depression scores on the Edinburgh Postnatal Depression Scale—EPDS were TMB (mean 8.1±4.3) versus TMB-coaching (mean 8.6±4.4); with a significant effect size for the change score from baseline to 3 months postpartum (0.01; 95% CI 0.00 to 0.03; p=0.16). In adjusted regression models, EPDS scores were lower in TMB (95% CI −7.7 to −3.3) when compared with a cohort receiving standard treatment, called CONCEPTION.²⁷ Participants with baseline EPDS >8 reported scores lower (per SD, 95% CI −7.5 to −3.5) in TMB (n=425) than the women in the CONCEPTION cohort.^{28 29} Moreover, participants who received online TMB with supportive telephone motivational coaching (online and coaching) reported higher general self-efficacy at 3 months postpartum compared with participants in the online only group.^{28 29} Moreover, these mothers with higher levels of self-efficacy also reported increased (positive) perceptions of infant personal-social skills at 6 months postpartum. These preliminary findings highlight the importance of investigating maternal factors, such as self-efficacy and their influence on child development.

Emotion regulation

While it is widely accepted that maternal well-being and parenting behaviours significantly influence child development, the specific mechanisms through which maternal care influences developmental outcomes remain largely unclear. Parental emotion regulation (ER) has been identified as a key factor that optimises parental functioning and fosters positive child development.^{21 22 24 30 31} Parental ER, defined as the ability to monitor, evaluate and adjust emotional responses, is a known protective factor against psychological distress.^{32 33} Previous research has demonstrated a mirroring effect, whereby parents who struggle to regulate their own emotions often have children with similar challenges.34,36 Parenting interventions aimed at educating and supporting parents in recognising stress and its triggers, identifying dysfunctional thought patterns and more importantly, positively reframing these thoughts, have been found to enhance 37,39ER as well as improve parental perception of child ER.^{37 40}

Parental ER and self-efficacy are critically important psychosocial protective factors for child development. They are both strongly correlated with parenting capacity, serving as essential competencies for effective parenting.⁴¹ Despite their important roles in promoting optimal child development, they are seldom examined together as predictors or moderators of the relationship between programme participation and child developmental outcomes.

Effects of supportive interventions on maternal psychosocial functioning

Supportive therapy during pregnancy plays a critical role in enhancing maternal psychological well-being and reducing the risk of adverse mental health outcomes. This therapeutic approach, focusing on emotional support, stress management and interpersonal connection, has been shown to significantly mitigate symptoms of depression, anxiety and pregnancy-related stress.⁴² This suggests that supportive therapy can promote resilience, strengthen social support networks and foster a stronger and more positive identity as a new mother, all of which are essential during the profound psychological transition of pregnancy.⁴³ Brief counselling interventions, ranging between 5 and 12 sessions on average, were associated with a lower likelihood of onset of perinatal depression (pooled risk ratio (RR), 0.61 (95% CI 0.47 to 0.78); 17 RCTs (n = 3094); I2 = 39.0%) and positive child outcomes when compared with controls.⁴⁴

Thus, evidence indicates that pregnant individuals receiving supportive or interpersonal therapies exhibit lower rates of perinatal depression and greater overall satisfaction with their prenatal experience.^{45 46} Moreover, these interventions can buffer the physiological effects of prenatal stress, potentially reducing the risk of negative birth outcomes and future child developmental concerns.^{47 48} Supportive therapy is particularly effective when integrated early in prenatal care, as secondary services, since they can be tailored to individual psychosocial contexts, including socioeconomic status, relationship dynamics and prior mental health history.⁴⁹ A secondary perinatal programme, such as TMB, typically refers to specialised services that support individuals during the perinatal period (from pregnancy through the first year postpartum) but are not part of routine primary care. Given its preventive and cost-effective nature, secondary perinatal programmes that offer supportive therapy may represent a valuable component of comprehensive prenatal care, aligning with public health objectives to promote maternal mental health and optimise developmental trajectories for children.

Child outcomes at 24 and 48 months

Understanding the potential protective role of a maternal secondary perinatal programme such as TMB and the impact of maternal factors, such as self-efficacy and ER, on child development at 24 and 48 months is essential for identifying risk trajectories and informing early interventions. These developmental stages correspond to crucial windows in language acquisition, socio-emotional regulation and executive functioning.^{50 51} A substantial body of evidence shows that adverse perinatal conditions such as maternal depression, anxiety and psychosocial distress during the perinatal period are associated with increased risks of internalising and externalising problems, attachment insecurity and impaired cognitive outcomes in children.^{1 19 47 49 52 53} Notably, many of these effects persist into the preschool years and often become more reliably detectable at 24–48 months, underscoring the importance of medium-term follow-up.^{54 55} Evaluating outcomes at 24 and 48 months enables a clearer picture of how maternal mental health influences child development over time and how these effects may be mitigated through integrated care models.¹⁸ This approach can directly inform clinical practice, service design and public health policy.

Knowledge gaps

Understanding the early parental predictors of negative child outcomes can help mitigate the risk of developmental delays, which have a relatively early onset.^{17 56 57} Despite growing evidence highlighting the impact of parental distress on child development, much of the current literature has focused on individual and family therapy once developmental difficulties or deficits have already emerged. In contrast, research has underscored the value of preventative measures, which are not only advantageous but more cost-effective than responsive interventions.^{58 59} Thus, the present study aims to address this critical gap in knowledge and practice by capitalising on the existing maternal well-being study, TMB, through the implementation of child follow-up and the assessment of parent and child factors, with the goal of identifying pathways for prevention and early intervention. The current research aims to enhance our understanding of child development while also contributing to long-term benefits for children and families.

Child follow-up study

Specifically, to address these knowledge gaps, the current study aims (1) to investigate whether the provision of social support during pregnancy is associated with improved cognitive and social-emotional functioning among children aged 24 and 48 months. Further, this research aims (2) to determine whether maternal ER and self-efficacy are related to child cognitive and social-emotional development at 24 and 48 months of age. It is hypothesised that children of mothers who participated in the TMB programme with weekly coaching will have greater cognitive and social-emotional development compared with children whose mothers completed the TMB programme independently (Aim 1). We will also explore if there are observed differences in child outcomes based on intervention arm or group assignment (online only, or online and supportive coaching). Further, it is hypothesised that children of mothers who reported higher ER and self-regulation at 24 and 48 months postpartum will experience fewer delays in their cognitive and social-emotional development (Aim 2).

Methods

Population

The Parents & Babies research study is a 2-year longitudinal follow-up of children’s cognitive and social-emotional development following the TMB programme.^{28 29} TMB is a secondary perinatal programme, open-label, randomised-controlled, superiority trial based at Sainte Justine Hospital Center (ClinicalTrials.gov ID NCT05110456), which was adapted for French-speaking individuals (2021–2023, Quebec, Canada). Participants were French-speaking women recruited during their second trimester and considered as presenting a risk for clinical depression (EPDS total score: 9–16). Those with symptoms of psychosis or substance abuse were excluded. The online perinatal programme consisted of 10 modules designed to promote mental health and well-being among current and future parents. Specifically, the intervention comprised a self-guided web-based platform offering cognitive-behavioural-based therapy and exercises. Each online module took 10–20 min to complete, and participants were advised to complete one module every 1–2 weeks. The programme focused on recognising and distinguishing between harmful and helpful thoughts, reducing cognitive distortions and negative automatic thoughts, fostering social connection and healthy communication, enhancing positive co-parenting relationships and supporting parental ER. Participants were assigned to one of two intervention groups; those who completed the online modules independently and those who completed the modules with weekly coaching provided by a trained professional (ie, telephone support condition). Individuals in the telephone support condition received 10 weekly calls; nine during pregnancy and one at 6 weeks postpartum. Guided by a scripted protocol, these calls encouraged participants to use the online materials, supported them in identifying strategies to overcome obstacles, helped apply the content to real-life situations and boosted their success in using effective coping strategies.

The Parents & Babies follow-up study plans to recruit maternal-child dyads from Quebec, Canada, who participated in the TMB programme. Questionnaires will be collected online through the secure online REDcap platform,⁶⁰ naturalistic observation sessions will be administered via Microsoft Teams, and all in-person data collection (eg, maternal IQ assessment) will take place at the Faculty of Education at McGill University in a space set up for clinical training and supervision with double-sided mirrors, which can also accommodate children and families for research activities. Completion of the questionnaires is expected to take approximately 35–45 min, naturalistic sessions will last no more than 30 min, and in-person assessments should be completed within 60 min. To achieve a medium effect size with 80% power and a two-tailed alpha of 5%, the study requires a sample of n=210. As such, we aim to recruit a minimum of n=250 maternal-child dyads to factor for potential attrition between the two study timepoints. All data will be analysed in RStudio. While the TMB programme is primarily focused on the mother, she is encouraged to involve a partner, such as the child’s other parent or another supportive individual, to promote a broader support network. Although the proposed study centres on maternal factors, future research should consider examining the role and influence of the other parent or caregiver in shaping child outcomes.

Patient and public involvement

Neither patients nor the public were involved in the design, conduct, reporting nor dissemination plans of our research as such involvement was not feasible given that the present study constituted a child follow-up to an already completed maternal trial.

Eligibility criteria

Inclusion criteria

Participants aged 18 years and older who can read and communicate in French, have access to a personal computer, tablet or smartphone and have previously participated in the TMB programme during pregnancy.

Exclusion criteria

Participants will not be included in the study if they did not previously participate in the TMB programme during pregnancy.

Measures

Participants who consent will be invited to engage in two study timepoints: T1 (24 months postpartum) and T2 (48 months postpartum). Each timepoint involves the completion of a set of online questionnaires, an in-person maternal cognitive assessment (conducted only during the first timepoint) and a virtual naturalistic observational assessment via Microsoft Teams, which offers institutional security and compliance features and tools such as the Advanced Threat Protection and Data Loss Prevention. The larger maternal study (ie, TMB) will provide a variety of multi-domain data, including maternal prenatal mental health (eg, EPDS, Generalised Anxiety Disorder 7-item scale, Perceived Stress Scale), as well as demographic information (eg, education, age, socioeconomic status, etc). Data collection will be conducted in French, using validated translations which have demonstrated reliability and validity in French-speaking perinatal population, and research team-translated measures.61,63

Maternal well-being

In the current study, maternal well-being will be assessed at T1 and T2 using a variety of measures. Depression will be measured using the EPDS, a 10-item self-report measure, widely recognised as being the primary screening tool for depressive symptoms among pre- and postpartum women.^{64 65} Responses are rated on a 4-point Likert scale, with possible total scores falling between 0–30 and higher scores reflecting a greater presence of depressive symptoms.⁶⁴ In the proposed study, total scores will be used. The EPDS has demonstrated strong psychometric properties in both prenatal and postpartum settings (internal consistency typically ranging from 0.80 to 0.90^{64 65}). Anxiety levels will be measured using the Generalised Anxiety Disorder Scale (GAD-7), a 7-item questionnaire assessing worry and anxiety symptoms and is commonly used among pregnant and postpartum individuals.^{66 67} Items are scored on a 4-point Likert scale, with total scores ranging between 0 and 21, and higher scores indicating greater anxiety severity.⁶⁷ The total score will be used in the current study. The GAD-7 is widely used and has demonstrated strong psychometric properties, with internal consistency generally ranging from 0.89 to 0.92.^{67 68} Further, perceived stress will be measured using the Perceived Stress Scale (PSS-10), a valid and reliable 10-item measure assessing overall levels of perceived stress.⁶⁹ Participants rate on a 4-point Likert scale (0=never, to 4=always), how often they experienced a particular feeling over the past month, with total scores ranging from 0 to 40 and higher scores reflecting greater levels of perceived stress.⁶⁹ The total PSS-10 score will be used. This measure has demonstrated satisfactory internal consistency, test-retest reliability and validity in both pregnant and postpartum women (internal consistency ranging from 0.78 to 0.91^{65 69 70}). The French Adaptation of the Coparenting Relationship Scale (CRS) will be administered to assess the quality of the coparenting relationship.⁷¹ The 35-item parent-report measure evaluates responses across seven dimensions of coparenting behaviours.^{71 72} Each item is scored on a 7-point Likert scale, ranging from 0 (not true of us) to 6 (very true of us), with higher scores indicating a more positive and adaptive co-parenting relationship.^{71 72} A total score is calculated by averaging scores across all 35 items. The quality of the co-parenting relationship is a critical component of well-being. Specifically, lower ratings of relationship satisfaction and support between parents have been associated with elevated risks of depressive and anxiety symptoms.⁷³

Child cognitive functioning

Child developmental domains will be assessed at two time points: first at 24 months and again at 48 months. Specifically, child cognitive functioning will be measured using the Ages and Stages Questionnaire (ASQ-3⁷⁴), the MacArthur-Bates Communicative Development Inventory (MB-CDI⁷⁵) and the Child Development Inventory (CDI⁷⁶). The ASQ-3 is a parent-completed developmental screening tool for children aged 1–66 months, measuring skills on five domains including gross motor, fine motor, social-personal, communication and problem-solving (general cognitive development⁷⁴). This scale has excellent validity (0.82 to 0.88), test-retest reliability (0.91) and inter-rater reliability (0.92⁷⁴). The MB-CDI is a parent-report designed to evaluate language and communication skills in young children, including vocabulary, grammar, sentence complexity and the use of gestures.⁷⁵ This scale has great psychometric properties, with a Cronbach’s alpha of 0.97, and validity ranging from 0.88 to 0.90.⁷⁵ The CDI is a 300-item questionnaire that has been validated for use with children aged 15 months to 6 years of age. It measures child development in eight areas including social, self-help, gross motor, fine motor, expressive language, language comprehension, letters and numbers.⁷⁶ The French validated short-form (70-item) version⁷⁷ will be used. This version has demonstrated high sensitivity (84%; 95% CI 72% to 92%) and specificity (92%; 95% CI 84% to 97%) for detecting children with borderline and intellectual disability (IQ<86).⁷⁷

Child social-emotional functioning

The Ages and Stages Questionnaire, Social Emotional – Second Edition (ASQ:SE-2⁷⁸) and The Child Behaviour Checklist 1.5–5 (CBCL 1.5–5⁷⁹) will be used to measure child social-emotional functioning. The ASQ:SE-2 is a parent-completed developmental screening tool focused on social-emotional development in young children.⁷⁸ It assesses self-regulation, compliance, social communication, adaptive functioning, autonomy, affect and interaction with others and has excellent validity (0.84), test-retest reliability (0.89) and internal consistency (0.71–0.91⁷⁸). The CBCL 1.5–5 is a 99-item questionnaire used to screen for behavioural, social and emotional outcomes (ie, emotional reactivity, anxiety/depression, attention problems, aggressive behaviour, etc) in children aged 1.5 to 5 years old.⁷⁹ Total score and subscale score will be calculated and analysed independently. The CBCL has been validated in French and has demonstrated good reliability (0.68–0.92⁷⁹).

Maternal factors

Maternal ER will be assessed using the Cognitive Emotion Regulation Questionnaire (CERQ), a 36-item self-report measure assessing the use of ER strategies in response to a stressful situation or event.³¹ Responses are measured on a 5-point Likert scale (1=almost never, to 5=almost always), and assess nine domains including self-blame, blaming others, acceptance, focusing on planning, positive refocusing, rumination, positive reappraisal, putting into perspective and catastrophising. Higher scores on each subscale indicate a greater likelihood of using a particular ER strategy.³¹ In the proposed study, the total score, which represents the sum of all the subscale scores, will be used to assess individuals’ overall use of ER strategies. The CERQ has sound psychometric properties and subtest reliability ranging from 0.68 to 0.81.³¹ Self-efficacy will be measured using the Parental Cognitions and Conduct Towards the Infant Scale (PACOTIS⁸⁰) and The Me as a Parent Scale (MaaPs⁸¹). The PACOTIS is a self-report questionnaire designed to measure parental perceptions about their parental role and behaviour tendencies towards their children. It has demonstrated good internal consistency for each subscale (0.68–0.82) and test-retest reliability.^{81 82} The MaaPs is a 16-item questionnaire assessing parenting self-regulation, using four subscales including self-efficacy, personal agency, self-sufficiency and self-management, with higher scores indicating greater parenting self-efficacy perceptions.⁸¹ This scale has demonstrated good internal consistency (0.85), with the subscales showing adequate internal consistency (0.62–0.84⁸¹). Finally, the Wechsler Adult Intelligence Scale (WAIS-IV⁸³) will be administered to participating mothers as a measure of standardised intelligence. The WAIS includes a core battery of 10 unique subtests that assess four specific domains of intelligence, including verbal comprehension, perceptual reasoning, working memory and processing speed, which will be administered in person.⁸³ Given that it has been identified as a predictor of child cognitive ability, maternal IQ will be used as a control variable.

Parent-child interaction and parenting quality (questionnaire, brief interview and naturalistic observation)

Furthermore, mother-child interaction and parenting quality will be measured using a questionnaire, a virtual naturalistic observation assessment and a virtual brief interview, conducted via Microsoft Teams. Parental reflective functioning refers to the parent’s ability to consider their child’s own mental experiences, including their own thoughts and emotions.^{84 85} This will be measured using the Parental Reflective Functioning Questionnaire (PRFQ⁸⁶), which is an 18-item self-report measure that has demonstrated good reliability and validity, including scale reliabilities from adequate to good (0.60 to 0.82⁸⁷). The PRFQ has been associated with parenting features including parental warmth, self-efficacy and greater parenting sensitivity.^{84 85 87} The Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO⁸⁸) is a measure of parent-child interactions for children between the ages of 10 to 47 months. It involves observing a brief, 8 to 10 min interaction and scoring 29 items on a 3-point rating scale from 0 (absent, no behaviour observed) to 1 (barely, or some brief, minor or emerging behaviour), to 2 (clearly, definitive, strong or frequent behaviour88,90). This measure will be used to assess parental behaviours in the context of mothers’ interaction with their child across four domains: affection (ie, physical and verbal expressions of affection, positive emotion, positive regard), responsiveness (ie, reacting sensitively to their child’s cues and expressions of need and interest), encouragement (ie, parents supporting their child’s efforts, exploration and independence) and teaching (ie, cognitive stimulation, joint attention, shared play^{88 90}). The PICCOLO has good validity and reliability (interrater reliability ranging from 0.74 to 0.80, and internal consistency of each domain ranging from 0.75 to 0.80⁸⁸), making it a strong measure for assessing developmentally supportive parent-child interactions.^{88 89} Additionally, the StimQ₂-StimQ Cognitive Home Environment Questionnaire/Toddler,^{91 92} a measure of the cognitive home environment, will be administered in a brief, structured interview format, taking approximately 15 to 20 min. Extensive research demonstrates that the quality of the home environment is strongly linked to children’s developmental outcomes and early academic achievement.⁹¹ Elements of cognitive stimulation in the home, such as access to learning materials that support play and reading, parental verbal responsivity and encouragement of new skill acquisition, have consistently been associated with enhanced cognitive and social-emotional development.⁹¹ The StimQ₂-Toddler demonstrates good psychometric properties including internal consistency ranging from 0.86 to 0.93, and strong external reliability (0.83 to 0.89^{91 93 94}). Tables1 2 present the Parents & Babies questionnaire data collection and the naturalistic observational assessment and interview timeline, respectively. Conducting these measures virtually allows us to observe mother-child interactions in the natural home environment, while offering families greater flexibility and reducing barriers associated with in-person lab visits.

Table 1. Parents & Babies questionnaire data collection timeline.

Questionnaire	Timepoint 1 (24 months)	Timepoint 2 (48 months)
Maternal well-being
Edinburgh Postnatal Depression Scale (EPDS)	X	X
Generalised Anxiety Disorder 7-item (GAD-7)	X	X
Perceived Stress Scale (PSS-10)	X	X
Brief Coparenting Relationship Scale (B-CRS)	X	X
Child cognitive functioning
Ages and Stages Questionnaire—Third Edition (ASQ-3) (24-month and 48-month versions)	X	X
MacArthur-Bates Communicative Development Inventory (MB-CDI)	X	X
Child Development Inventory (CDI)—General Developmental Scale	X	X
Child social-emotional functioning
Ages and Stages Questionnaire, Social-Emotional—Second Edition (ASQ:SE-2) (24-month and 48-month versions)	X	X
Child Behaviour Checklist 1.5–5 (CBCL 1.5–5)	X	X
Maternal emotion regulation
Cognitive Emotion Regulation Questionnaire (CERQ)	X	X
Maternal self-efficacy
Parental Cognitions and Conduct Towards the Infant Scale (PACOTIS)	X	X
Maternal/Paternal Postnatal Attachment Scale (MPAS)	X
Me as a Parent Scale (MaaPs)	X	X
Parental Reflective Functioning Questionnaire	X	X
Control variables
Healthcare (Régie de l’assurance maladie du Quebec - RAMQ) Data	X	X
Parity and Breastfeeding Questionnaire	X
Languages Spoken Questionnaire	X

RAMQ, Régie de l'assurance maladie du Québec.

Table 2. Parents & Babies interview and naturalistic observational assessment timeline.

Assessment	Timepoint 1 (24 months)	Timepoint 2 (48 months)
Wechsler Adult Intelligence Scale, Fourth Edition (WAIS-IV)—(In-Person)	X
StimQ2—Toddler Interview—(Virtual via Secure Videoconferencing Platform, ie, MS Teams)*	X	X
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO)—(Virtual via Secure Videoconferencing Platform, ie, MS Teams)	X	X

^*Administered only to a subset of participants.

By using a combination of questionnaires, assessments and observations, we will gain comprehensive insight into parenting behaviours, child functioning and the quality of the parent-child relationship, including communication patterns and emotional responsiveness.

Feasibility and reliability of virtual naturalistic observation

While in-person naturalistic observation is the gold standard of child observational studies, it is methodologically challenging to study children’s perceptions and evaluations of everyday events. Conducting maternal-child interactions virtually offers a valuable alternative, enabling researchers to observe families within their natural home environment, thereby increasing ecological validity. Videoconferencing has emerged as an effective method for facilitating naturalistic observation remotely, enabling richer contextual insights and more authentic interactions.⁹⁵ Additionally, virtual formats improve participant accessibility and engagement while reducing logistical constraints and associated costs, positioning them as a viable and efficient research tool. McRoy et al⁹⁶ provide comprehensive guidelines for conducting remote assessments with young children, emphasising the selection of appropriate technology platforms, the adaption of traditional assessment tasks for virtual settings, and the importance of developmental suitability and engagement. Drawing from their experience with over 600 preschoolers, the authors outline strategies to address challenges commonly reported when conducting virtual naturalistic observation, such as maintaining children’s attention, scheduling sessions effectively and safeguarding personal health information, thereby providing a practical framework for researchers and practitioners in early childhood assessment.⁹⁶

Data analysis

The data will be analysed in RStudio and a two-sided significance level of 0.05 will be used for all analyses. Demographic and other baseline variables will be compared between intervention groups using descriptive statistics. Aim 1. Linear mixed models for repeated measures over time will be used to compare the effects of maternal intervention condition (online intervention only vs online intervention with telephone support) on measures of child cognitive development and social-emotional development, at T1 (24 months) and T2 (48 months), respectively. Random effects of time and group, as well as time-group interactions with linear trends, will be explored. Aim 2. To examine associations between parental ER and self-efficacy and child outcomes, separate models will be conducted to examine associations between maternal ER and self-efficacy on child development outcomes at the same timepoints. Exploratory analyses will be conducted to examine whether parental ER and self-efficacy mediate the relationship between the intervention group and child outcomes, using causal inference models. Child sex will be added as a potential moderator of the interactions between maternal variables and child developmental outcomes.

Variables of interest will be added to the analyses to determine covariates (ie, child age and sex, maternal age, parent educational attainment, household income, etc). Multiple imputation will be used for handling any missing data. This approach has been shown to produce valid statistical inference that reflects the uncertainty associated with the estimation of missing data.⁹⁷ Video-recorded sessions will be coded and analysed using validated protocol. Sensitivity analyses will be conducted to explore the potential confounding effects of various familial factors, some of which will be collected as part of maternal demographic information (ie, parent relationship status, co-parenting relationship, social support, and/or maternal mental health including GAD-7, PSS-10, EPDS).

Discussion

Maternal psychological distress critically influences child development, yet limited research has investigated the mechanisms through which maternal behaviour influences child developmental trajectories. While parental ER and self-efficacy have been shown to optimise parental functioning, they have not been examined together as potential moderators of child development in the context of a prenatal parenting intervention. More broadly, the impact of maternal ER and SE on child development during a critical postpartum period remains underexplored. This is imperative given that mothers who experience emotional and psychological stressors during and after pregnancy face greater difficulty providing a nurturing and sensitive parenting environment, compared with those without such challenges.^{7 98} Preventative prenatal interventions have the potential to be highly impactful, as increasing evidence demonstrates that even mild levels of parenting stress during pregnancy can influence fetal development and have lasting consequences into adolescence and adulthood. Although research on the impact of parental distress on child development is growing, much of the existing literature emphasises postnatal treatment after developmental deficits have emerged, rather than the role of preventative parenting support. Yet, evidence shows that preventative interventions are not only more effective, but also more cost-efficient than ad-hoc care.^{58 59} The child follow-up study thus seeks to demonstrate the significance of preparing parents for the transition to parenthood and to examine its effects on parenting behaviours and subsequent child development outcomes.

Expected contributions

 Building on Belsky’s Process Model of Child Development, which emphasises the combined influence of parent, child and contextual factors on parenting behaviours,⁵ it is evident that not all determinants exert equal influence. Identifying key parental factors shaped by the broader environmental context (ie, social support) is therefore fundamental, as these may represent the most promising avenues for intervention and the greatest potential for optimising child development.

To our knowledge, no study has investigated whether the provision of a parenting intervention, both with and without telephone support, during pregnancy enhances child cognitive and social-emotional functioning at 24 and 48 months, or whether these developmental outcomes are shaped by maternal ER and self-efficacy. To address these gaps, the child follow-up study aims to investigate whether a parenting intervention delivered during pregnancy improves cognitive and social-emotional functioning in children aged 24 and 48 months (Aim 1). Further, the study aims to determine whether maternal ER and self-efficacy are related to child cognitive and social-emotional development during a critical postpartum period (Aim 2). This research has the potential to guide the development of prenatal preventive interventions and deepen our understanding of the interplay between maternal factors and child development. The insights gained can inform key prevention and early intervention strategies, equipping expectant parents for the transition to parenthood, and ultimately fostering positive developmental outcomes in children. Figure 1 provides the trial flow diagram of the longitudinal child follow-up study integration into the original maternal Toi-Moi-Bébé secondary perinatal programme.

Figure 1. Longitudinal child follow-up study included into the original maternal Toi-Moi-Bébé trial flow diagram. Flowchart of participant selection. Flow of participants through each stage of the study, including enrolment, allocation, follow-up, analysis and the child follow-up study as a continuation of the maternal focused study. Reasons for exclusion are provided at each stage. TMB, Toi, Moi, Bébé.

This protocol aims to gather evidence on how prenatal parental interventions can promote both parent and child outcomes, underscoring the importance of early parental interventions in supporting familial health. From a preventive perspective, it also highlights the need to examine how key parenting factors, including self-efficacy and ER, interact to promote optimal child development. This protocol and the findings from this study could provide preliminary evidence to support the benefits of these early interventions, laying the grounds for future research to validate the cost-effective nature of preventive action in contrast to responsive interventions.

Ethics and dissemination

Ethics approval for this study (MP-37-2025-10894) was sought through the Research Institute of the McGill University Health Centre Research Ethics Board. The study partnership with the original maternal study, Toi Moi Bébé, was subject to a data transfer agreement. Both principal investigators of the original maternal study (SMC and CMH) and child follow-up (TM) are co-investigators on the respective projects, which strengthens collaboration and enhances the feasibility of study continuity.

All participants will be provided with informed consent prior to participation. We will obtain maternal consent electronically and verbal assent for child participants. Confidentiality will be maintained through the de-identification of all study data. Participation in the study is voluntary, and participants are free to withdraw at any time, without consequences.

Participants will be compensated for their participation in the study, receiving US$20 for full completion of the survey at each study time point (for a total of up to $C50). Individuals who participate in the maternal cognitive assessment and virtual naturalistic observational assessments will receive an additional US$10 for participation in each assessment (ie, in-person cognitive assessment and virtual mother-child interactional assessments, for a total of up to US$50).

Data management

Information collected from participants will be de-identified and stored on a secure server at the Research Institute of the McGill University Health Centre. The access, use and storage of data will be conducted following the guidelines outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans ⁹⁹. Any data collected via secure video platforms (ie, PICCOLO and StimQ₂-Toddler collected via Microsoft Teams) will also be stored on a secure server at the Research Institute of the McGill University Health Centre; meeting Research Data Management policies overseen by the McGill Digital Research Services Hub (https://www.mcgill.ca/drs/rdm).

Dissemination

Findings from this study will be disseminated through peer-reviewed and open-access publications, as well as presentations at national and international psychological associations (Canadian National Perinatal Research Meeting—2026/2027; Society for Research in Child Development—2027/2029 bi-annual conference) and other related scientific conferences.