Actively Recruiting

Phase Not Applicable
Age: 6Months - 8Months
All Genders
Healthy Volunteers
NCT06512649

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

Age: 6Months - 8Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Santa Maria Nascente

Milan, Italy, 20148

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here