Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities
Condition: Epigenomics; Developmental Disability; Early Intervention; Parent-Child Relations
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      Infants with developmental disabilities present a high risk of behavioral and socio-emotional
      problems. Their parents are themselves at risk of developing emotional and affective
      disorders which can impact the quality of the interaction with the infant. Early parenting
      empowerment focused on parent-infant interaction are beneficial in supporting infants
      development and parental adjustment. By using a multi-layer approach to outcomes assessment
      (i.e., behavioral, neuroendocrine and epigenetic outcomes), the present longitudinal,
      multi-center, change-promoting clinical trial is aimed at assessing the effectiveness of an
      early parenting empowerment intervention based on video-feedback technique to support
      maternal responsiveness and the socio-emotional development of infants with developmental
      disabilities.
    

Detailed description: 
      RATIONALE: Infants with developmental disabilities (e.g., cerebral palsy and genetic
      syndrome) present a high risk of behavioral and socio-emotional problems. Their parents are
      themselves at risk of developing emotional and affective disorders which can impact the
      quality of the interaction with the infant. Typical development research is highlighting the
      potentials of biological markers of less-than-optimal mother-infant interaction, such as
      altered neuroendocrine regulation (i.e., cortisol and oxytocin). Increased infants' salivary
      cortisol reactivity has been found in response to experimental suspension of maternal
      responsiveness (Still-Face paradigm, SFP). On the other hand, oxytocin administration to
      mothers increases responsiveness to infants socio-emotional signals and oxytocin has also
      been associated with socioemotional stress regulation in humans. Interestingly, previous
      research suggests that the epigenetic regulation of specific genes (i.e., SLC6A4, NR3C1,
      BDNF, OXTR) transcription might be affected by alterations of maternal caregiving behavior.
      Nonetheless, to the best of our knowledge, to date there is no investigation of the
      epigenetic vestiges of the effects of an early parenting intervention (i.e., video-feedback)
      on the behavioral outcomes of infants with developmental disabilities.

      SPECIFIC AIM 1: To assess the effectiveness of the video-feedback intervention to enhance the
      socio-emotional behavior of infants with developmental disabilities.

      EXPERIMENTAL DESIGN AIM 1: The present research project will include two groups
      (Video-Feedback Group, VFG; Phone-Call Group, PCG) and four phases: T0, baseline assessment;
      T1, post-intervention assessment ; T2, follow-up#1 (3 months after the intervention); T3,
      follow-up#2 (6 months after the intervention). All infants and their mothers will be enrolled
      at three Child Neuropsychiatric Units in Lombardia Region (OU1, Scientific Institute IRCCS E.
      Medea; OU2, Fondazione Istituto Neurologico Casimiro Mondino, Pavia, Italy; OU3, Università
      degli Studi, Brescia, Italy). At each phase, mother-infant interactions will be videotaped
      during SFP. The VFG dyads will participate to a 6-session videofeedback intervention The aim
      of the video-feedback intervention is to support maternal sensitivity to the infants'
      behaviors focusing on different aspects of mother-infant interactions. PCG mothers will be
      contacted by telephone weekly for 6 weeks, and will be asked for information on their
      infants' development. No advice about sensitive parenting will be given to the control PCG
      mothers during these conversations. In each of the three Units, the intervention will be
      conducted by psychologists/developmental neuropsychiatrists trained on the video-feedback
      intervention. Infant behavior regulation will be observationally assessed at each of the four
      phases of the research project.

      SPECIFIC AIM 2: To examine the effects of the intervention on maternal responsiveness.

      EXPERIMENTAL DESIGN AIM 2: Paralleling infants' behavioral assessment, maternal
      responsiveness will be assessed at each project phase by means of video-tapes. Additionally,
      maternal reports of emotional and affective states, including depressive and anxious symptoms
      and stress perception in taking care of the infant, will be obtained and controlled for. The
      rate of change over the phases of the project in maternal self-reported emotional states,
      feelings of attachment and coded sensitivity will concur in defining the efficacy of the
      intervention in the VFG subjects against the PCG counterparts.

      SPECIFIC AIM 3: To investigate the immediate and follow-up pre/post intervention variations
      in the neuroendocrine functioning (i.e., salivary cortisol and oxytocin) and in the DNA
      methylation of specific genes associated with infants' behavioral regulation such as: NR3C1,
      BDNF, SLC6A4, OXTR.

      EXPERIMENTAL DESIGN AIM 3: Salivary samples will be collected from the infant at each phase
      before and after the SFP interaction. For what pertains neuroendocrine markers (i.e.,
      salivary cortisol and oxytocin) saliva will be collected from the infants (and mothers) using
      an oral cotton swab and it will be collected in eppendorf, centrifuged and conserved
      according to kit producer guidelines. Samples will be obtained before (1 sample) and after (3
      samples: +10, +20, and +30 minutes) the SFP procedure. Due to circadian rhythm of the
      neuroendocrine systems, all the interactions will occur in the morning, between 9.00 and
      12.00 AM. For what pertains the epigenetic profiling, saliva will be collected once per
      phase. DNA methylation will be assessed at the different CpG sites within the promoter
      regions of specific target genes (NR3C1, SLC6A4, BDNF, OXTR) previously associated with
      infants' behavioral development. The rate of change in neuroendocrine concentrations of
      cortisol and oxytocin as well as the alterations in global and site-specific DNA methylation
      of the selected genes will be used as independent biomarkers of the effects of the
      video-feedback intervention.

      SIGNIFICANCE AND INNOVATION: First, the study has the potential to bring new evidence in the
      clinical practices promoting an early intervention for mothers of infants with developmental
      disabilities. Second, the multi-center nature of this clinical trial will provide a common
      early intervention program in the Italian context, with potential indirect implication for
      healthcare costs optimization. Indeed, it has been shown that interventions starting earlier
      in childhood may be more effective and efficient than those provided in a later period of
      life. Consistently, the project will be conducted during the first year of life of infants
      with the potential to permanently alter infants' development trajectories and to yield a
      significant economic return for the healthcare system. Finally, examining the epigenetic
      variations related to early parenting intervention the project introduces an innovative
      approach to early intervention research for families of infants with developmental
      disabilities.
    

Intervention name(s): Video-Feedback Intervention; Phone-Call Intervention
Intervention type(s): Behavioral; Other
Intervention description(s): Mothers and infants of the VFG arm will participate to a 6-session video-feedback intervention structured as follows: 4 sessions of video-review discussions with a trained clinician + 2 sessions of integrative intervention aimed at translating into practical caregiving the insights developed during the video-review discussions.; Mothers of the PCG arm will participate in 6-session of telephone call during which a trained collaborator will ask details on different domains of infants behavioral development.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: DNA methylation; Epigenetic regulation; Video-feedback intervention; Developmental disability; Cerebral palsy; Genetic syndromes; Parent-infant interaction; Early intervention; Neuroendocrine regulation