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Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD

NCT ID: NCT05208411

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-28

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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ImPACT group

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

Group Type EXPERIMENTAL

Project ImPACT: Improving Parents As Communication Teachers

Intervention Type BEHAVIORAL

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.

No intervention group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

9 Months

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. dr. Herbert Roeyers, PhD

Role: STUDY_CHAIR

University Ghent

Locations

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Ghent University

Ghent, Oost-Vlaanderen, Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Dr. Sara Van der Paelt, PhD

Role: CONTACT

[email protected]
+32 486 93 14 48

Prof. dr. Herbert Roeyers, PhD

Role: CONTACT

[email protected]

Facility Contacts

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Sara Van der Paelt, PhD

Role: primary

[email protected]
+32 486 93 14 48

Other Identifiers

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814302 - ONZ-2022-0587

Identifier Type: -

Identifier Source: org_study_id