NCT05208411

Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD

The Impact of a Parent-mediated Intervention on Social Behaviour and Social Brain Development in Infants at High Risk for Autism Spectrum Disorder

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: University Ghent · Academic / Other
• Sex: All
• Age: 9 Months – 18 Months
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Project ImPACT: Improving Parents As Communication Teachers	Project ImPACT ("Improving Parents As Communication Teachers", Ingersoll \& Dvortcsak, 2019) is a promising evidence-based parent-mediated intervention that is part of a class of naturalistic, developmental, behavioral interventions (NBDIs). NBDIs involve the use of behavioral principles of learning to teach skills chosen from a developmental sequence in naturalistic play-setting and using natural rewards. Skills selected as relevant for intervention are those that allow the child to participate more fully within reciprocal interactions with the adult. In recent years the program has been adapted for use with infants and toddlers at elevated likelihood of ASD. These adaptations have made this program appropriate for younger children and children who are experiencing social communication delays but do not have an ASD diagnosis.

Timeline

• Start date: 2022-03-28
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-26
• Last updated: 2023-11-27

Locations

1 site across 1 country: Belgium