Status:
COMPLETED
Early Parenting Intervention: Bio-behavioral Outcomes in Infants With Neurodevelopmental Disabilities
Lead Sponsor:
IRCCS Eugenio Medea
Collaborating Sponsors:
Fondazione Istituto Neurologico Casimiro Mondino
Università degli Studi di Brescia
Conditions:
Epigenomics
Developmental Disability
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 i...
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 d...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA FOR INFANTS
- Infants with equivalent age range 3-to-18-months
- Mild to moderate psychomotor delay
Exclusion
- Presence of severe sensorial (auditory, visual) deficits
- Genetic syndrome with known functional implications for the epigenetic regulation of target genes
- ELIGIBILITY CRITERIA FOR MOTHERS
- Inclusion Criteria:
- Mastery of Italian language
- Age \> 18 years
- Living with the father of the infant
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2023
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03853564
Start Date
September 1 2019
End Date
April 5 2023
Last Update
October 18 2023
Active Locations (3)
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1
IRCCS E. Medea
Bosisio Parini, Lecco, Italy, 23842
2
Università degli Studi di Brescia
Brescia, Italy, 25123
3
Fondazione Istituto Neurologico Casimiro Mondino
Pavia, Italy, 27100