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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Child emotional-behavioral profile
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Good understanding of the Italian language
- •No cognitive impairments and/or diagnosed psychiatric disorders
- •No use of psychotropic medications
- •Participation in the parental support program (only for the ACEs+ group)
排除标准
- 未提供
研究组 & 干预措施
ACE +
Pregnant women who have scored ≥ 3 on the Adverse Childhood Experiences (ACE) questionnaire.
干预措施: Home visiting programme (Behavioral)
ACE -
Pregnant women who have scored < 3 on the Adverse Childhood Experiences (ACE) questionnaire.
结局指标
主要结局
Child emotional-behavioral profile
时间窗: At 18 months of child age (corrected age for prematurity)
Child emotional and behavioral functioning assessed using the Child Behavior Checklist for ages 1.5-5 years (CBCL/1.5-5)
Maternal mental well-being
时间窗: At 18 months postpartum
Maternal mental well-being assessed using the Mental Health Continuum-Short Form (MHC-SF)
次要结局
- Child development(At 3 months and 18 months of child age)
- Change in maternal mental well-being(Once during the first trimester of pregnancy and once at 18 months postpartum)
- Mother-infant synchrony(At 3 months of child age)