Growing Up in Multifactorial Risk Conditions

NCT07477899 | Enrolling By Invitation

• 1 other identifier: 1090
• Study Type: interventional
• Target: 352
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Child emotional-behavioral profile

  Child emotional and behavioral functioning assessed using the Child Behavior Checklist for ages 1.5-5 years (CBCL/1.5-5)

  At 18 months of child age (corrected age for prematurity)

• Maternal mental well-being

  Maternal mental well-being assessed using the Mental Health Continuum-Short Form (MHC-SF)

  At 18 months postpartum

Secondary Outcomes (3)

• 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

• Child development

  At 3 months and 18 months of child age

Study Arms (2)

ACE +

EXPERIMENTAL

Pregnant women who have scored ≥ 3 on the Adverse Childhood Experiences (ACE) questionnaire.

Behavioral: Home visiting programme

ACE -

NO INTERVENTION

Pregnant women who have scored \< 3 on the Adverse Childhood Experiences (ACE) questionnaire.

Interventions

Home visiting programme BEHAVIORAL

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.

ACE +

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Azienda Socio Sanitaria della Brianza: collaborator

Study Sites (1)

IRCCS Eugenio Medea

Bosisio Parini, LC, 23842, Italy

Location

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: June 26, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

IT (1)