Supporting communication between parents and babies from birth: The Communicating and Understanding your Baby (CUB) study

Not Applicable

Active, not recruiting

• Conditions: Autism Spectrum Disorder; Mental Health - Autistic spectrum disorders

• Registration Number: ACTRN12620000019909
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

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

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Autism Diagnostic Observation Scale (2nd edition) - Total score, and Social Affect and Restricted and Repetitive Behaviours subscale<br><br>Method of assessment: Researcher-administered semi-structured play assessment with infant. Scored by a researcher with demonstrated high level reliability, who is blind to treatment group. [ Follow-up assessment (when infant is 24 months of age)];Manchester-Assessment of Caregiver-infant Interaction (MACI) - Caregiver Non-directiveness subscale <br> <br>Method of assessment: Parent-Infant free play interaction sample. Scored from video by researcher with demonstrated high level reliability, who is blind to treatment group. [ Immediate treatment endpoint (when infant is 9 months of age)]