Early intervention for infants at risk of Autism Spectrum Disorder
The Impact of a Parent-mediated Intervention on Social Behaviour and Social Brain Development in Infants at High Risk for Autism Spectrum Disorder
NA · University Ghent · NCT05208411
This study is testing if a special program for parents and their babies can improve communication skills and brain activity in infants at higher risk for autism.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 9 Months to 18 Months |
| Sex | All |
| Sponsor | University Ghent (other) |
| Locations | 1 site (Ghent, Oost-Vlaanderen) |
| Trial ID | NCT05208411 on ClinicalTrials.gov |
What this trial studies
This randomized-controlled trial evaluates the impact of an early intervention on the social-communicative skills and brain activity of infants at elevated risk for Autism Spectrum Disorder (ASD). The intervention, based on the Project ImPACT model, involves 12 weekly sessions with parents and their infants, focusing on enhancing communication skills. Participants will be assessed at three intervals: before the intervention, immediately after, and six months post-intervention to measure behavioral and neural changes. The study targets infants aged 9 to 18 months who are either siblings of diagnosed ASD children or born preterm.
Who should consider this trial
Good fit: Ideal candidates are infants aged 9 to 18 months who are either siblings of children diagnosed with ASD or were born preterm.
Not a fit: Patients with other neurological or developmental disorders will not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve social-communicative abilities in infants at risk for ASD, potentially altering their developmental trajectory.
How similar studies have performed: Previous studies have shown that parent-implemented interventions can effectively enhance social skills in children with ASD, suggesting potential success for this adapted approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elevated likelihood of ASD: the child must be a preterm (less than 30 weeks of gestation) or a sibling/half-sibling of a child with diagnosed ASD. * Parents are Dutch, English on French speakers. Exclusion Criteria: * The child must not have a diagnosis of other neurological or developmental disorders.
Where this trial is running
Ghent, Oost-Vlaanderen
- Ghent University — Ghent, Oost-Vlaanderen, Belgium (RECRUITING)
Study contacts
- Study coordinator: Dr. Sara Van der Paelt, PhD
- Email: sara.vanderpaelt@ugent.be
- Phone: +32 486 93 14 48
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.
Conditions: Autism Spectrum Disorder, Autism, Siblings, Preterm, Elevated likelihood of ASD