NCT07477899

Growing Up in Multifactorial Risk Conditions

Growing Up in Multifactorial Risk Conditions (CORE): Effects of an Early Parenting Support Program on Maternal Well-Being, Child Socio-Emotional Development, Bio-Behavioral Synchrony, and Epigenetic Patterns

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: IRCCS Eugenio Medea · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The perinatal period brings significant physiological and emotional changes in mothers, linked to pregnancy, childbirth, and caring for a newborn. While pregnancy is often experienced positively, various stressors can impact maternal well-being and child health. Maternal stress can lead to vascular issues (e.g., hypertension, preeclampsia) or mental health concerns like depression and anxiety. Recent studies show depressive symptoms occur in 41.45% of women in the first trimester, with clinical depression in 9.85%. Postpartum depression has an estimated incidence of 10-20%, with strong continuity from prenatal depression. Stressors, including adverse childhood experiences (ACEs) and maternal psychological issues, often lead to emotional dysregulation. This, through intergenerational transmission, can impact a child's emotional regulation into adolescence. Intergenerational transmission involves both biological mechanisms (endocrine, neurophysiological, epigenetic) and social mechanisms (parenting style, early relationship quality). Sensitive, reciprocal adult-child interactions are essential for socio-emotional and cognitive development, and a child's emotional regulation abilities predict later emotional-behavioral issues. Understanding perinatal risk predictors is key to developing programs that reduce such risks. For example, factors like ACEs, unfavorable conditions, complications during pregnancy, and neurodevelopmental challenges in children can negatively affect the child's cognitive, emotional, and behavioral functioning, maternal well-being, epigenetic changes, and dyadic synchrony. Yet, risk factors do not prevent adaptation and may coexist with protective factors that support maternal well-being and child development. Early parenting support is thus essential, particularly in cases with multiple risks. Research indicates that challenges in implementing support programs often arise from insufficient identification of women at risk of psychological distress during pregnancy and postpartum. In many cases, these issues go unrecognized and untreated, or intervention happens late. It is crucial that prenatal screenings assess potential risk factors to identify women who could benefit from psychological and parenting support starting early in pregnancy. Such multidisciplinary interventions aim to limit intergenerational transmission of mental health issues, reducing impact on a child's emotional, behavioral, and cognitive development. Evidence increasingly supports that Home Visiting (HV) programs benefit both maternal mental health and child development. These programs help mothers manage psychopathological risks and parenting stress while fostering strong attachment and interactions that promote the child's emotional-behavioral development. Primary Objectives To investigate, at 18 months of child age (adjusted for prematurity), whether for mothers with perinatal risk, an HV-based parenting support intervention affects: 1.1. The child's emotional-behavioral profile, using the Child Behavioral Checklist 1.5/5 (CBCL); 1.2. Maternal mental well-being, using the Mental Health Continuum-Short Form (MHC-SF). Secondary Objectives Considering cumulative perinatal risk factors, examine if the HV program: 2.1. Increases maternal well-being for the ACE+ group from T0 (pre-intervention, first trimester) to T8 (post-intervention, child at 18 months); 2.2. Promotes mother-child synchrony at 3 months, in relational functioning (mother-child behavior) and cardio-respiratory activity (HRV and RSA); 2.3. Enhances child developmental competencies at 3 and 18 months (domains: (1) motor, (2) adaptive behaviors, (3) socio-emotional, (4) cognitive, (5) communication). Exploratory Objectives Examine if the HV program influences the epigenetic status of mothers (pre- and postnatal) and children (at 3 months). DNA methylation variations will be assessed in mothers and children in the HV program group versus controls, focusing on target genes related to stress regulation (SLC6A4, NR3C1, BDNF), neural plasticity (BDNF), social interaction (DRD4, OXTR), and tactile stimulation perception (Piezo1, Piezo2, TRPV1, TRPM8, MRGPRB4). Additional candidate genes will be identified through computational research.

Detailed description

The perinatal period-defined as the span from conception to the first two years of life-is marked by significant physiological and emotional changes in the mother, associated with pregnancy, childbirth, and neonatal care. Although pregnancy is often experienced positively by most parents, various stressors can considerably impact maternal well-being (and that of the couple), as well as fetal and child health. Maternal stress can induce physiological effects, such as vascular disorders (e.g., hypertension and preeclampsia), or affect mental health, leading to conditions like depression and anxiety. A recent study reports a 41.45% prevalence of depressive symptoms and a 9.85% prevalence of depression during the first trimester. Postpartum depression is estimated to occur in 10-20% of cases, with significant continuity from prenatal to postnatal depression. Numerous stressors, including a prior history of adverse experiences and/or trauma (i.e., Adverse Childhood Experiences, ACEs), and the occurrence of maternal psychological disorders during the perinatal period often co-occur with emotional dysregulation. Through intergenerational transmission mechanisms, this may impair a child's ability to regulate emotions, with effects extending into adolescence. Intergenerational transmission involves both biological mechanisms (e.g., endocrine, neurophysiological, epigenetic processes) and socio-relational mechanisms (e.g., parenting style and early relationship quality). For instance, a sensitive, reciprocal adult-child interaction is essential for fostering the child's socio-emotional and cognitive development. The child's ability to regulate emotions serves as an important predictor of later dysfunctional behaviors and emotional or behavioral problems in early childhood. Understanding predictors of perinatal psychological challenges is crucial for implementing risk reduction programs. Risk factors such as adverse personal history (ACE), unfavorable conditions, pre-, peri-, and post-natal complications, and the child's neurodevelopmental challenges may negatively impact the child's cognitive and emotional-behavioral functioning, maternal well-being, epigenetic modifications in both mother and child, and dyadic synchrony. Conversely, risk factors do not preclude positive adaptation and can coexist with protective factors that enhance maternal well-being and child development. Thus, early parental support interventions are fundamental as protective factors, especially in contexts where multiple risk factors coexist . Evidence suggests that barriers to implementing support interventions often stem from insufficient early identification of women at risk for psychological distress during pregnancy and postpartum. Frequently, these conditions are undetected and untreated, or support begins only when the woman's distress has significantly progressed. Consequently, prenatal screenings should assess potential risk factors to identify women who may benefit from psychological and parenting support interventions starting in the early months of pregnancy. Such multidisciplinary interventions aim to mitigate or halt the intergenerational transmission of mental health issues, thus reducing the impact on the child's emotional, behavioral, and cognitive development. Objectives Primary Objective: To investigate, at 18 months of child age (adjusted for prematurity), whether a home-visiting (HV) parental support program for women at perinatal risk impacts: Objective 1.1: the child's emotional-behavioral profile, assessed with the Child Behavioral Check-List 1.5/5 (CBCL); Objective 1.2: maternal mental well-being, assessed using the Mental Health Continuum-Short Form (MHC-SF). Secondary Objective: Assessing the cumulative impact of perinatal risk factors, determine if the HV program facilitates: Objective 2.1: an improvement in maternal mental well-being in the ACE+ group from T0 (pre-intervention assessment: first trimester) to T8 (post-intervention assessment: 18 months postpartum); Objective 2.2: mother-child synchrony at 3 months postpartum concerning relational functioning (maternal and child behavior) and cardio-respiratory activity (heart rate variability, HRV; respiratory sinus arrhythmia, RSA); Objective 2.3: development of child competencies across key domains (motor, adaptive behaviors, socio-emotional, cognitive, and communication skills) at 3 and 18 months. Study Design The study employs a multicenter, interventional, prospective design with longitudinal data collection, implemented within an ASST Brianza Service aimed at identifying "at-risk" pregnant women based on ACE questionnaire scores (Adverse Childhood Experiences; Felitti, 2013). The service, titled "WECAREGENERATION-1000days" (Resolution.0000808.21-09-2023), includes home visits conducted by trained professionals (midwives), where psychosocial intervention is delivered from early pregnancy through the child's first 18 months. Intervention: Home Visiting and Psychosocial Support Program The Lombardy Region identified HV as an effective strategy for promoting maternal and neonatal physical and mental health, using the "Positive Thinking" guide, developed by the World Health Organization (WHO, 2015), for managing perinatal depression and providing structured psychosocial support. The program includes an introductory session and five modules covering the perinatal and postpartum periods. Each module is adapted to the child's developmental stage and maternal needs, emphasizing maternal well-being, mother-child relationship, and relationships with significant others. Recruitment Recruitment will take place in ASST Brianza's maternal health centers. During the first obstetric booking, eligible pregnant women will be informed about the study, and consent will be obtained. Women with an ACE score ≥3 who agree to participate will form the clinical ACE+ group. A control ACE- group will be selected from non-risk pregnant women (ACE \< 3), with assessments added to standard care to measure study outcomes. Study Phases The longitudinal study includes baseline (T0 = first trimester) and endpoint (T8 = 18 months postpartum) assessments, with six intermediate follow-ups. F1: Baseline T0-Mental health (MHC-SF) and sociodemographic questionnaires. F3: T2, third trimester-Maternal epigenetic status from saliva samples; emotional status assessed with DASS-21. F4: T3, postnatal-Biomedical risk profile assessment for neonate. F5-F7: Follow-up (3, 6-12, and 18 months)-Epigenetic sampling, developmental profile evaluation, and video assessment of mother-child interaction. Adherence to Procedures The procedures outlined in the study protocol (e.g., video recording of mother-infant interactions) are utilized in the pediatric field. Additionally, the Principal Investigator (PI) possesses extensive experience with the methodologies employed and applied in various studies conducted at the 0-3 Center of the IRCCS "Eugenio Medea," involving mothers and infants aged between 0 and 18 months, the results of which have been the subject of several scientific publications. Therefore, based on the PI's prior experience, no significant difficulties regarding adherence to the intervention by the parents participating in this study are anticipated. Moreover, certain characteristics of the study may promote adherence among mothers, specifically: The procedures outlined in the protocol (e.g., questionnaire completion) related to the intervention will be integrated into the routine practices of the regional health service, eliminating the need for additional visits. Following the initial obstetric booking (T0), mothers will receive home visits, a practice that, by minimizing the need to travel to outpatient services, is likely to facilitate greater adherence to the study. The video recording of mother-infant interaction at three months of age (T4) will take place at the 0-3 Center, necessitating travel for the mother (and her infant) from home to the IRCCS Medea. Considering the geographic area of interest of ASST-Brianza and the location of the IRCCS Medea, it is estimated that the maximum distance a participating mother may need to travel will not exceed 25 kilometers. The commitment required for the video recording is approximately 30 minutes, accounting for the welcome phase, infant adaptation, and the time needed to put on the sensor-equipped shirts. To promote adherence, mothers are encouraged to be accompanied by a relative. Typically, mothers welcome participation in video-recorded interactions. In this context, mothers are highly motivated to engage, particularly because they receive feedback on their child's development and interaction patterns. If requested, they are provided with a copy of the video. Mothers will benefit from both obstetric and psychosocial support from qualified and trained personnel, which generally serves as a motivating factor for women during the transition to parenthood. Mothers may also be motivated by the opportunity to gain insights into their child's emotional-behavioral functioning up to 18 months of age, which can serve as an incentive for participation and completion of all study phases. All these procedures are conducive to promoting adherence among study participants. It is essential that mothers (and fathers) understand all requests made of them and have the opportunity to ask any questions they may have. Assessment of the Benefit/Risk Ratio for the Population The project presents an optimal balance between risks and benefits. Potential Risk Factors: Novelty: The project is characterized as innovative; however, existing literature, the experience of the researchers involved, and the preliminary evaluation of more innovative procedures (e.g., the use of sensor-equipped shirts for bio-signal acquisition, which, combined with behavioral analyses, may serve as proxies for assessing the quality of early mother-infant interactions) suggest that participation in the study poses no undesirable effects or risks to participants (children, women). Tolerance to Experimental Procedures: The study involves procedures that have already been utilized in pediatrics, many of which have been employed in previous studies conducted at the 0-3 Center. Moreover, all procedures (i.e., saliva collection, video recording of mother-infant interaction) will be promptly halted if the infant shows signs of irritation, crying, or discomfort, or if the parent expresses an unwillingness to continue, regardless of the reasons provided. Potential Benefits: The possibility of monitoring/supporting the mental health status of women during the transition to parenthood and the psychosocial development of the child. Acquisition of evidence regarding the bio-behavioral mechanisms underlying the potential protective effect that an early parenting support program could have on primary and secondary outcomes. The multifactorial approach adopted (considering adverse experiences in the mother's history, unfavorable psychosocial conditions, pre-, peri-, and postnatal complications, and neurodevelopmental difficulties in the child) will enhance understanding of the biological and behavioral processes involved in intergenerational transmission and associated with reduced emotional regulation capacity in children. The study will facilitate synergy between a research center (IRCCS) and the territorial services provided by the regional health service (ASST Brianza), with the potential to develop best practices for screening, assessment, and early intervention in families deemed at risk.

Conditions

• Adverse Childhood Experiences
• Developmental Risk
• Psychomotor Development Disorders
• Neurodevelopmental Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Home visiting programme	This intervention aims to help women identify their resources and abilities, as well as to support them in choosing strategies that are most effective for maintaining individual and family balance. Additionally, by strengthening maternal mental health, the intervention is designed to enhance parental competencies, contributing to the establishment of a positive foundation for the development of their children.

Timeline

• Start date: 2024-06-26
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-03-17
• Last updated: 2026-03-23

Locations

1 site across 1 country: Italy