Actively Recruiting
Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder
Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2024-07-22
48
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
F
Fondazione Don Carlo Gnocchi Onlus
Lead Sponsor
U
University of Milano Bicocca
Collaborating Sponsor
AI-Summary
What this Trial Is About
H1The primary goal of this intervention study is to learn if very early parent-mediated intervention in children at risk for neurodevelopmental disorders in the first year of life can be implemented in routine care, positively impacting early sensory-motor and socio-communicative developmental trajectories and reducing the developmental gap in children with signs of concern. H2: It is here postulated that early intervention with active parental involvement can reduce parental stress, as well as improve parental understanding and responsiveness to the child's communication cues. H3: An important part of our work will be analysing data about early social and joint attention behaviours in recruited children and comparing them at different time points. The hypothesis is to find early differences between groups at baseline and to detect a change before and after the intervention. For this reason, in our study design, we decided to use technologies to collect data on quantitative measures during play-structured and laboratory sessions to understand changes in developmental trajectories. H4: Given the potential role of genetic and immunological mechanisms in ASD, one of the study's secondary aims is to investigate the impact of an early intervention programme on epigenetic changes and inflammatory and immune response. After enrolment and baseline assessments (T0), children will be allocated to the three groups: * Group 1 - Clinical Monitoring Group (CM): Siblings of TD children subjects with no signs of concern * Group 2 - Active Monitoring Group (AM): Siblings of ASD children with no signs of concern * Group 3 - Early Intervention Group (EI): Siblings classified as "with signs of concern" at baseline evaluation. All children will be re-evaluated after 6 months (T1) and after 12 months (T2).
CONDITIONS
Official Title
Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at recruitment less than or equal to 8 months.
- Has a sibling diagnosed with autism spectrum disorder.
- Normal neurological examination.
You will not qualify if you...
- Presence of focal neurological signs or suspicion of genetic-metabolic disorders.
- Known or suspected genetically determined condition in sibling.
- Significant language barrier within the family.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Santa Maria Nascente
Milan, Italy, 20148
Actively Recruiting
Research Team
C
Chiara Fanciullacci
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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