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Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities

NCT03853564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-10-18

No results posted yet for this study

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.

Conditions

  • Epigenomics
  • Developmental Disability
  • Early Intervention
  • Parent-Child Relations

Interventions

BEHAVIORAL

Video-Feedback Intervention

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.

OTHER

Phone-Call Intervention

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.

Sponsors & Collaborators

  • Fondazione Istituto Neurologico Casimiro Mondino

    collaborator UNKNOWN

  • Università degli Studi di Brescia

    collaborator OTHER

  • IRCCS Eugenio Medea

    lead OTHER

Principal Investigators

  • Rosario Montirosso, PsyD · IRCCS E. Medea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2023-02-05
Completion
2023-04-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03853564 on ClinicalTrials.gov