Clinical Trials Directory

Trials / Completed

CompletedNCT03323918

ImPACT Intervention for Children With ASD

Parent-implemented Intervention for Children With ASD: Effect on Social Communication and Brain Activation

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University Ghent · Academic / Other
Sex
All
Age
18 Months – 48 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 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.

Conditions

Interventions

TypeNameDescription
OTHERImPACTTeaching parents to train social communicative skills as outlined in arm description.
OTHERTAUTAU can include targeting eating and sleeping problems, adaptive skills, or other goals.

Timeline

Start date
2016-11-01
Primary completion
2021-11-28
Completion
2021-11-28
First posted
2017-10-27
Last updated
2022-11-09

Locations

1 site across 1 country: Belgium

Source: ClinicalTrials.gov record NCT03323918. Inclusion in this directory is not an endorsement.