Clinical Trial of an Early Parenting Empowerment Intervention to Promote Socioemotional Development in Infants With Developmental Disabilities: Parent and Infant Behavioral, Neuroendocrine and Epigenetics Outcomes

Status: Completed
Location: See all (3) locations...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3 months
Maximum Age: 1
Healthy Volunteers: f
View:

• Infants with equivalent age range 3-to-18-months

• Mild to moderate psychomotor delay

• Mastery of Italian language

• Age \> 18 years

• Living with the father of the infant

Locations
Other Locations
Italy
IRCCS E. Medea
Bosisio Parini
Università degli Studi di Brescia
Brescia
Fondazione Istituto Neurologico Casimiro Mondino
Pavia
Time Frame
Start Date: 2019-09-01
Completion Date: 2023-04-05
Participants
Target number of participants: 45
Treatments
Experimental: Video-Feedback Group (VFG)
Dyads of mothers and their infant with developmental disability who are exposed to the video-feedback intervention focused on different domains of mother-infant quality of interaction (number of sessions: 6).
Sham_comparator: Phone-Call Group (PCG)
Dyads of mothers and their infant with developmental disability who are not exposed to the video-feedback intervention, instead they receive phone calls focused on obtaining descriptions of different domains of infant behavioral development (number of sessions: 6)
Sponsors
Collaborators: Fondazione Istituto Neurologico Casimiro Mondino, Università degli Studi di Brescia
Leads: IRCCS Eugenio Medea

This content was sourced from clinicaltrials.gov