Official Title
Emotional-behavioral Regulation in Children With Neurodevelopmental Disabilities: an Exploratory Investigation of the Role of Genomic Variation, Proteomic Patterns, and Quality of Early Experience
Brief Title
Emotional Regulation in Children With ND: the Role of Genomic Variation, Proteomic Patterns, and Early Experience
Protocol ID
NCT05004090
Lead Sponsor
IRCCS Eugenio Medea
Brief Summary
Children with neurodevelopmental disabilities (ND) represent an heterogeneous population
characterized by a wide range of clinical diagnoses (e.g., cerebral palsy, sensory
impairment, psychomotor retardation), which are associated with various deficits that
emerge early in the child's life. Although it has been broadly demonstrated that children
with ND exhibit several differences in social-emotional skills and emotional-behavioral
regulation, the underlying mechanisms that are associated with more or less impaired
developmental trajectories remain still partially unexplored. While several studies have
investigated the role of biological and environmental factors in the emotional behavioral
regulation of typically developing children or children with risk conditions other than
ND (e.g., children who are victims of maltreatment), little research has jointly explored
the role of methylation, polymorphisms, and environmental experience in the
emotional-behavioral regulation of children with ND during the first years of life. The
aim of this project is to investigate biological (DNA methylation, polymorphic variants,
and proteomics) and environmental (e.g., painful and/or invasive nursing procedures,
proximity, and physical contact) factors that might be associated with the emotional
behavioral regulation of children with ND.
Detailed Description
Background: Children with neurodevelopmental disabilities (ND) are an heterogeneous
population characterized by a wide variety of clinical diagnoses, which are associated
with different deficits that emerge during infancy and childhood. Although diagnostic
framing may vary, several studies observed that children with ND share reduced
social-relational skills, characterized by lower interactive and dyadic attention skills
and decreased use of interpersonal communication cues. Although it has been broadly
demonstrated that children with ND exhibit several differences in social-emotional skills
and emotional behavioral regulation, the underlying mechanisms that are associated with
more or less impaired trajectories remain partially unexplored.
Primary aim: to explore in a sample of children with ND aged 3 to 24 months the
contribution of 1) methylation of candidate genes (e.g., OXTR, SLC6A4, BDNF, and DRD4),
2) polymorphisms in emotional-behavioral regulation, and 3) environmental experience
(i.e., adverse experiences and quality of parental behavior) in emotional-behavioral
regulation.
Secondary aim: 1) to explore a possible association between proteomics and
emotional-behavioral regulation in a sample of children with ND aged between 3 and 24
months; 2) to identify functional and structural patterns of candidate genes associated
with emotional behavioral regulation by applying a computational approach. Modules of
genes potentially associated with social-emotional development in networks of interaction
and spatio-temporal co-expression in the encephalon will also be identified.
Planned Activities:
Methods:the project involves a clinical group of children with ND and their mothers and a
control group of typically developing children and their mothers. Because of the nature
of the groups, the study is a quasi-experimental research design.
The study involves the following procedures:
- collection of biological material: saliva collection using non-invasive modalities
and the Oragene OG575 kit (Genotek DNA) and urine collection using non-invasive
modalities.
- administration of questionnaires and diary of proximity: the mother (both for the
clinical group and for the control group) will be asked to fill out some
questionnaires relating to their mood, habitual behavior and development of the
child. It will also be evaluated how much and in what way the mother spends in
physical contact (e.g. time spent caressing the baby; time spent holding the baby;
time spent when the baby is attached to the mother's breast). This data will be
derived through the use of a repurposed version of Raiskila et al.'s "closeness
diary" implemented in an electronic format, in the form of an APP (APP: inContatto);
- videotaping the Parent-Child Interaction in a semi-structured context in 5 different
phases in accordance with the Still Face paradigm (Tronick et al., 1978): Play,
Still#1, Reunion#1, Still#2, Reunion#2.
Interactions will be videotaped for subsequent behavioral coding using various coding
tools. The child's emotional-behavioral regulation will be coded using the coding
systems: a) Infant and Caregiver Engagement Phase, b) Infant Regulatory Scoring System
and Maternal Regulatory Scoring System by Tronik. In addition, infant and maternal
behavior will be coded using the Global Rating Scale coding system by Murray and maternal
touch behavior using the Maternal Touch Coding System by Provenzi.
Study Period
-
Enrollment Count
248 participants
Eligibility Criteria
Inclusion Criteria:
Children with ND:
- Age between 3 and 24 months (chronologically or corrected in the case of children
born preterm);
- mild to moderate developmental delay documented by clinical signs (e.g., symptoms of
brain injury on neurological examination or neuroimaging) or by developmental scales
(i.e., Griffiths III scales) associated with various diagnoses (e.g., cerebral
palsy, prematurity);
- absence of genetic syndromes. The Griffiths III scale will be used to assess the
child's overall level of development.
Typical developmental children:
- birth to term;
- age between 3 and 24 months (chronological);
- absence of peri- or postnatal pathology.
Inclusion criteria for mothers (DN and typical development):
- age above 18 years;
- good understanding of the Italian language;
- absence of cognitive difficulties and/or psychiatric disorders;
- no intake of psychotropic medications;
- not part of a single-parent family.
Exclusion Criteria: refer to the inclusion criteria.
Filters
Neurodevelopmental Disabilities
Emotional Regulation
Epigenetics
Parental Factors
UNKNOWN
CHILD