Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD (SAPIENS)

University Ghent

Status: Enrolling

Conditions: Autism Spectrum Disorder

Treatments: Behavioral: Project ImPACT: Improving Parents As Communication Teachers

Study type: Interventional

Funder types: Other

Identifiers

NCT05208411

814302 - ONZ-2022-0587

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 9 to 18 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

80 participants in 2 patient groups

ImPACT group

Experimental group

Description:

Group of children at elevated likelihood of ASD who will receive the ImPACT intervention

Treatment:

Behavioral: Project ImPACT: Improving Parents As Communication Teachers

No intervention group

No Intervention group

Description:

Group of children at elevated likelihood of ASD who won't receive any intervention