A randomised-controlled trial of a parent-mediated intervention for optimising social and communication development of newborns at increased familial risk of autism spectrum disorders

Telethon Kids Institute0 sites130 target enrollmentJanuary 14, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 14, 2020

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

•Inclusion criteria for the trial are:
•(a)Pregnant woman (eligible inclusion answer \= Yes)
•(b)Carrying a singleton pregnancy (eligible inclusion answer \= Yes);
•(c)Carrying a foetus with a relatively ‘high’ or ‘moderate’ likelihood of developing ASD based on the following criteria (eligible answer \= Yes):
•High likelihood: The foetus has a biological mother, biological father, or full sibling with a clinical diagnosis of ASD. The diagnosis of the ‘proband’ (index case with the autism diagnosis) is confirmed by a copy of the diagnostic report.
•Moderate likelihood: The foetus has a biological mother, biological father or full sibling with ADHD or intellectual disability (with no known cause), OR a biological grandparent, biological uncle/aunt, half sibling with autism. The diagnosis of the ‘proband’ (index case with the autism, ADHD or intellectual disability diagnosis) is confirmed by a copy of the diagnostic report.
•(d)To the best of their knowledge, the primary carer and offspring are intending to remain in the Perth or Melbourne metropolitan area for the next two and a half years (eligible inclusion answer \= Yes); and
•(e)English is the main language spoken at home (eligible inclusion answer \= Yes).

•Exclusion criteria for the trial are:
•(a)The foetus/offspring has been diagnosed with a serious medical condition requiring ongoing care, as determined by the study team (exclusion answer \= yes).
•(b)The proband has a known genetic mutation associated with their clinical diagnosis (e.g., tuberous sclerosis complex, PTEN mutation etc.) that isn’t typically inherited (exclusion answer \= yes).
•(c)The primary carer has a serious mental or physical health condition requiring ongoing care, as determined by the study team (exclusion answer \= yes).