Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03853564 |
Other study ID # |
RF-2016-02361884 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
September 1, 2019 |
Est. completion date |
April 5, 2023 |
Study information
Verified date |
October 2023 |
Source |
IRCCS Eugenio Medea |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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, UniversitĂ
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.