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Clinical Trial Summary

This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of infants with elevated likelihood of Autism Spectrum Disorder (ASD). The children´s social-communicative abilities and the related brain activity will be evaluated at three time points: before the start of the intervention (pre-intervention), immediately after its conclusion (post-intervention) and 6 months after its conclusion (follow-up).

Clinical Trial Description

Previous research has shown that parent-implemented interventions are effective in improving the social skills of children with autism spectrum disorder (ASD).Considering that several differences in social and non-social skills start to emerge before a diagnosis can be made, this project aims to investigate the effects of an adapted prodromal version of an evidence-based parent-mediated intervention (Project ImPACT) in children with an elevated likelihood to develop ASD (namely siblings and children who were born preterm). The effect of the intervention will be evaluated at both behavioural and neural levels. The intervention is suitable for infants and consists of 12 session with the child and his/her parents, of maximum 2 hours each, one session per week, delivered by therapists of the home guidance and home guidance centers in Flanders. Children between 9 and 18 months old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention group or a no-intervention group (monitoring only). The families will be invited to come to the Faculty of Psychology and Pedagogical Sciences at three time points: before the start of the intervention, immediately after the end of the intervention (which is expected to last 12 weeks) and 24 weeks after the end of the intervention. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05208411
Study type Interventional
Source University Ghent
Contact Dr. Sara Van der Paelt, PhD
Phone +32 486 93 14 48
Status Recruiting
Phase N/A
Start date March 28, 2022
Completion date December 2025

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