Prodromal ImPACT Intervention for Children at Elevated Likelihood of ASD

NCT05208411 | Unknown

• 1 other identifier: 814302 - ONZ-2022-0587
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Autism Spectrum Disorder

Keywords

Autism; Autism Spectrum Disorder; Siblings; Preterm; Elevated likelihood of ASD

Outcome Measures

Primary Outcomes (2)

• Bigger change from baseline in the parent-child interaction in the intervention group compared to the no-intervention group.

  Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.

  Outcome at 3 months after entry(post-test)

• Bigger change from post-test in the intervention group in the parent-child interaction compared to the no-intervention group.

  Change in quality and frequency of behaviours (with the same unit of measure) within the Parent-Child Interaction coded through the Parent-Infant/Toddler Coding of Interaction (PInTCI). An increase is considered as a positive outcome.

  Follow-up at 6 months after post-test

Secondary Outcomes (15)

• Bigger change from baseline in Social Engagement in the intervention group compared to the no-intervention group.

  outcome at 3 months after entry (post-test)

• Bigger change from baseline in the score of imitation in the intervention group compared to the no-intervention group.

  outcome at 3 months after entry (post-test)

• Bigger change from baseline in the score of intentional communication in the intervention group compared to the no-intervention group

  outcome at 3 months after entry (post-test)

• Bigger change from baseline in attention disengagement in the intervention group compared to the no-intervention group

  outcome at 3 months after entry (post-test)

• 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.

  outcome at 3 months after entry (post-test)

Study Arms (2)

ImPACT group

EXPERIMENTAL

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

Behavioral: Project ImPACT: Improving Parents As Communication Teachers

No intervention group

NO INTERVENTION

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

Interventions

Project ImPACT: Improving Parents As Communication Teachers 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.

ImPACT group

Eligibility Criteria

• Age: 9 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• The child must not have a diagnosis of other neurological or developmental disorders.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Premature Birth

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Prof. dr. Herbert Roeyers, PhD

  University Ghent

  STUDY CHAIR

Central Study Contacts

Dr. Sara Van der Paelt, PhD

CONTACT

+32 486 93 14 48; sara.vanderpaelt@ugent.be

Prof. dr. Herbert Roeyers, PhD

CONTACT

herbert.roeyers@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: January 26, 2022
• Study Start: March 28, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)