Early intervention for siblings at risk of neurodevelopmental disorders
Early Recognition and Intervention in Siblings at High-risk for Neurodevelopmental Disorder
This study tests whether early support for parents can help babies who have a sibling with autism develop better social and communication skills in their first year of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 6 Months to 8 Months |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT06512649 on ClinicalTrials.gov |
What this trial studies
This intervention focuses on implementing early parent-mediated strategies for children at risk of neurodevelopmental disorders, particularly those with a sibling diagnosed with autism spectrum disorder. The study aims to assess the impact of these interventions on sensory-motor and socio-communicative development during the first year of life. Parents will be actively involved in the intervention, which is designed to reduce parental stress and enhance their responsiveness to their child's communication cues. Data will be collected through technological assessments of social behavior and joint attention, allowing for a detailed analysis of developmental trajectories over time.
Who should consider this trial
Good fit: Ideal candidates for this study are infants under 8 months old who have a sibling diagnosed with autism spectrum disorder and show no signs of neurological concerns.
Not a fit: Patients with significant neurological signs, genetic disorders, or language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve early developmental outcomes for children at risk of neurodevelopmental disorders.
How similar studies have performed: Other studies have shown promise in early interventions for neurodevelopmental disorders, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age at recruitment less than or equal to 8 months. * Sibling diagnosed with autism spectrum disorder * Normal neurological examination Exclusion Criteria: * Focal neurological signs/symptoms or suspicion of genetic-metabolic disorders * Genetically determined suspected or known conditions in brother/sister * Significant familial language barrier
Where this trial is running
Milan
- Santa Maria Nascente — Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Chiara Fanciullacci
- Email: ctu@dongnocchi.it
- Phone: 0039055 7393653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.