Early Parenting Intervention - Biobehavioral Outcomes in infants with Neurodevelopmental Disabilities (EPI-BOND):
Rosario Montirosso1, Elisa Rosa2, Roberto Giorda3
10-3 Center for the at-Risk Infant, Scientific Institute IRCCS E. Medea, Bosisio Parini, Lecco, Italy rosario.montirosso@lanostrafamiglia.it.
Insights
This study investigates early video-feedback intervention (VFI) for infants with neurodevelopmental disabilities (ND). VFI aims to improve infant socio-emotional behavior and maternal sensitivity, with potential neuroendocrine and epigenetic benefits.
Area of Science:
- Developmental Psychology
- Neuroscience
- Genetics
Background:
- Neurodevelopmental disability (ND) negatively impacts infant socio-emotional and behavioral development.
- Altered neuroendocrine hormones and epigenetic regulation are linked to suboptimal mother-infant interactions in ND.
- Parental sensitivity is crucial for child development; early interventions can enhance it.
Purpose of the Study:
- To assess the effectiveness of early video-feedback intervention (VFI) in infants with ND.
- To evaluate VFI's impact on infant socio-emotional behavior and maternal sensitivity.
- To examine VFI's influence on neuroendocrine and epigenetic regulation in mother-infant dyads.
Main Methods:
- A multi-center, longitudinal randomized controlled trial comparing VFI with a control group (telephone calls).
- Recruitment of infants (3-18 months) with ND from Italian child neuropsychiatric units.
- Assessment of mother-infant interactions via videotapes, maternal reports, and saliva samples for hormone and DNA methylation analysis (BDNF, NR3C1, OXTR, SCL6A4) at four time points.
Main Results:
- Primary outcomes: infant socio-emotional behavior and maternal sensitivity.
- Secondary outcomes: neuroendocrine hormone concentrations and target gene DNA methylation status.
- Feasibility, moderation, and confounding variables will be measured and controlled.
Conclusions:
- Early VFI is hypothesized to benefit infants with ND and their mothers.
- The study will provide insights into VFI's effects on behavioral, neuroendocrine, and epigenetic factors.
- Results will be disseminated through peer-reviewed publications and conferences.
Introduction:
Neurodevelopmental disability (ND) represents an adverse condition for infants' socio-emotional and behavioural development as well as for caregiving (eg, parental sensitivity) and mother-infant interaction. Adverse exposures are associated with altered neuroendocrine hormones concentrations (eg, oxytocin and cortisol) and epigenetic regulation (eg, methylation of stress-related genes), which in turn may contribute to less-than-optimal mother-infant interaction. Parental sensitivity is a protective factor for childrens' development and early parental interventions (eg, video-feedback intervention) can promote parental caregiving and better developmental outcomes in children. The present multi-centric and longitudinal randomised controlled trial aims to assess if and to which extent early VFI could benefit both infants and mothers in terms of behavioural outcomes as well as neuroendocrine and epigenetic regulation.
Methods And Analysis:
Dyads will be randomly assigned to the video-feedback Intervention Group or Control Group ('dummy' intervention: telephone calls). Infants with ND aged 3 to 18 months will be recruited from three major child neuropsychiatric units in northern Italy. A multi-layer approach to intervention effects will include videotapes of mother-infant interaction, maternal reports as well as saliva samples for hormones concentrations and target-gene methylation analysis (eg, BDNF, NR3C1, OXTR and SCL6A4) that will be obtained at each of the four assessment sessions: T0, baseline; T1, post-intervention; T2, short-term follow-up (3 month); T3, long-term follow-up (6 month). Primary effectiveness measures will be infant socio-emotional behaviour and maternal sensitivity. Neuroendocrine hormones concentrations and DNA methylation status of target genes will be secondary outcomes. Feasibility, moderation and confounding variables will be measured and controlled between the two groups.
Ethics And Dissemination:
Ethics approval has been obtained in all three participating units. Results of the main trial and each of the secondary endpoints will be submitted for publication in peer-reviewed journals and international conferences.
Trial Registration Number:
NCT03853564; Pre-results.
