Clinical trial No longer in our active list Interventional Ages 9 Months to 18 Months

Early intervention for infants at risk of Autism Spectrum Disorder

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

Run by University Ghent · NCT05208411 · Data updated 2026-05-14

This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.

This study is testing if a special program for parents and their babies can improve communication skills and brain activity in infants at higher risk for autism.

More Autism Spectrum Disorder trials

Quick facts

Study typeInterventional
Ages9 Months to 18 Months
SexAll
Enrollment80 (estimated)
SponsorUniversity Ghent
Academic / other
Locations1 site (Ghent, Oost-Vlaanderen)
Trial IDNCT05208411 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are infants aged 9 to 18 months who are either siblings of children diagnosed with ASD or were born preterm.

Probably not a fit

Patients with other neurological or developmental disorders will not benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized-controlled trial evaluates the impact of an early intervention on the social-communicative skills and brain activity of infants at elevated risk for Autism Spectrum Disorder (ASD). The intervention, based on the Project ImPACT model, involves 12 weekly sessions with parents and their infants, focusing on enhancing communication skills. Participants will be assessed at three intervals: before the intervention, immediately after, and six months post-intervention to measure behavioral and neural changes. The study targets infants aged 9 to 18 months who are either siblings of diagnosed ASD children or born preterm.

Why it matters

Potential benefit: If successful, this intervention could significantly improve social-communicative abilities in infants at risk for ASD, potentially altering their developmental trajectory.

How similar studies have gone: Previous studies have shown that parent-implemented interventions can effectively enhance social skills in children with ASD, suggesting potential success for this adapted approach.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Ghent University
    Ghent, Oost-Vlaanderen, Belgium
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.