Clinical trial NCT05208411: Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD
Official title: The Impact of a Parent-mediated Intervention on Social Behaviour and Social Brain Development in Infants at High Risk for Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: Autism
Autism Spectrum Disorder
Siblings
Preterm
Elevated likelihood of ASD
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 80
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Bigger change from baseline in the parent-child interaction in the intervention group compared to the no-intervention group.
timeFrame: Outcome at 3 months after entry(post-test)
measure: Bigger change from post-test in the intervention group in the parent-child interaction compared to the no-intervention group.
timeFrame: Follow-up at 6 months after post-test
Secondary outcomes:
measure: Bigger change from baseline in Social Engagement in the intervention group compared to the no-intervention group.
timeFrame: outcome at 3 months after entry (post-test)
measure: Bigger change from baseline in the score of imitation in the intervention group compared to the no-intervention group.
timeFrame: outcome at 3 months after entry (post-test)
measure: Bigger change from baseline in the score of intentional communication in the intervention group compared to the no-intervention group
timeFrame: outcome at 3 months after entry (post-test)
measure: Bigger change from baseline in attention disengagement in the intervention group compared to the no-intervention group
timeFrame: outcome at 3 months after entry (post-test)
measure: Bigger change from baseline in the intervention group compared to the no-intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
timeFrame: outcome at 3 months after entry (post-test)
measure: Bigger change from post-test in the intervention group in the score of Social Engagement compared to the no-intervention group.
timeFrame: follow-up at 6 months after post-test
measure: Bigger change from post-test in the score of a semi-structured social imitation task compared to the no-intervention group.
timeFrame: follow-up at 6 months after post-test
measure: Bigger change from post-test in the score of intentional communication in the intervention group compared to the no-intervention group
timeFrame: follow-up at 6 months after post-test
measure: Bigger change from post-test in the intervention group in electrophysiological spectral power and connectivity (theta and alpha band) in response to social versus non-social videos, measured with EEG.
timeFrame: follow-up at 6 months after post-test
measure: Bigger change from post-test in attention disengagement in the intervention group compared to the no-intervention group, measured with Eye-tracking
timeFrame: follow-up at 6 months after post-test
measure: Difference between intervention and no-intervention group in the severity score of the Autism Diagnostic Observational Scale - 2 (ADOS-2).
timeFrame: outcome at 9 months after entry
measure: Bigger change from baseline in the in the intervention group in the score of the Bayley Scales of Infant and Toddler Development - Third Edition - NL compared to the no-intervention group.
timeFrame: outcome at 9 months after entry
measure: Bigger change from baseline in the intervention group score of the Nijmeegse Ouderlijke Stress Index compared to the no-intervention group.
timeFrame: outcome at 9 months after entry
measure: Bigger change from baseline in the intervention group score of the Vineland screener questionnaire (0-6 years) compared to the no-intervention group.
timeFrame: outcome at 9 months after entry
measure: Difference between intervention and no-intervention group in language.
timeFrame: outcome at 9 months after entry
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Prof. dr. Herbert Roeyers, PhD
role: STUDY_CHAIR
References: