Clinical trial NCT03323918: ImPACT Intervention for Children With ASD
Official title: Parent-implemented Intervention for Children With ASD: Effect on Social Communication and Brain Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: European Union
First posted: 2017-10-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 will receive the intervention specifically targeting social-communicative abilities (Project ImPACT).

Group 2 will receive a generic intervention, that will not focus on social-communicative skills.
Primary purpose: TREATMENT

Brief summary: This randomised-controlled trial will assess the effect of an early intervention on the social-communicative abilities and brain activity of preschoolers with 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 several weeks 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). The aim of the present project is to investigate the brain activity changes that are at the basis of the changes observed in the children's behaviour. More specifically, the investigators will assess the effect of Project ImPACT, a parent-implemented intervention, which teaches parents techniques to stimulate the social-communicative abilities of their children.

The intervention is suitable for preschoolers with a diagnosis of ASD and consists of 18 sessions of maximum 2 hours each, one session per week, delivered by trained therapists of the home guidance services in Flanders. Children with a diagnosis of ASD (or children who are suspected of ASD) between 1,5 and 4 years old and their parents will participate in the study. They will be randomly assigned to the ImPACT intervention or treatment as usual. The investigators will assess the effect of the intervention on the children's social-communicative abilities, and on the neural and biological correlates of these abilities.

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 18 weeks) and 12 weeks after the end of the intervention.

Eligibility criteria: Inclusion Criteria:

* A clinical or working diagnosis of ASD

Exclusion Criteria:

-

Primary outcomes:
measure: Change from baseline in the score of the Early Social Communication Scales (ESCS)
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in the score of a semi-structured social imitation task
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in the score of the Brief Observation of Social Communication Change (BOSCC)
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from post-test in the score of the Early Social Communication Scales (ESCS)
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in the score of a semi-structured social imitation task
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in the score of the Brief Observation of Social Communication Change (BOSCC).
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in electrophysiological event-related potentials in response to voice and non-voice sounds (N1, N2 and P3 effects), measured with EEG
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in haemodynamic response function (oxyhaemoglobin and deoxyhaemoglobin concentration in the cerebral cortex) evoked by social attention cues, measured with NIRS (near infrared spectroscopy)
timeFrame: follow-up at 12 weeks from end of intervention
Secondary outcomes:
measure: Change from baseline in the score of the Autism Diagnostic Observational Scale - 2 (ADOS-2)
timeFrame: follow-up at 30 weeks from beginning of intervention
measure: Change from baseline in the score of the Mullen Scales of Early Learning (M-SEL)
timeFrame: follow-up at 30 weeks from beginning of intervention
measure: Change from baseline in the score of the Vineland screener questionnaire (0-6 years).
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from baseline in the score of the Nijmeegse Ouderlijke Stress Index
timeFrame: outcome at 18 weeks from start of intervention (post-test)
measure: Change from post-test in the score of the Vineland screener questionnaire (0-6 years).
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in the score of the Dutch adaptation of the MacArthur Communicative Development Inventories (NCDI - short form)
timeFrame: follow-up at 12 weeks from end of intervention
measure: Change from post-test in the score of the Nijmeegse Ouderlijke Stress Index
timeFrame: follow-up at 12 weeks from end of intervention
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
Study officials:
affiliation: UGent
name: Herbert Roeyers, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: