Social COmmunication Program supported by E-health (SCOPE) for infants and toddlers at elevated likelihood of autism spectrum disorder: study design of a cluster randomized controlled trial

Table 2 Outcome measures from baseline to follow-up

Measurement	Time^a	Instrument	Informant	Blind to group status?
Descriptives
Demographics	T1	Single questions	Parent(s)
IQ	T1	Bayley-III	Clinician
Problem behavior	T1	BITSEA	Parent(s)
Parental ASD symptoms	T1	SOV	Parent(s)
Primary outcome
Joint engagement	T1, T2, T3	JERI	Research assistant (RA) ^b	Yes
Secondary outcome
Change in ASD symptoms	T1, T2, T3	BOSCC (parent)	RA ^b	Yes
	T1, T3	BOSCC (clinician)	RA^c	Yes
	T1, T3	ADOS-2	Clinician	Yes
Expressive language	T1, T2, T3	JERI	RA ^b	Yes
Expressive language	T1, T3	N-CDI	Parent(s)
Adaptive functioning	T1, T3	Vineland Screener	Parent(s)
Parental well-being	T1, T2, T3	WEMWBS	Parent(s)
Parental well-being	T1, T2, T3	PSQ	Parent(s)
Parental skills	T1,T2, T3	JERI	RA ^b	Yes
`Satisfaction	T2	BESTE-O	Parent(s)
	T2	BESTE-H	BEAR professional
	T3	Satisfaction survey	Parent(s)
Cost measurements	T1, T2, T3	Tic-P	Parent(s)

Bayley-III Bayley Scales of Infant and Toddler Development, BITSEA Brief Infant–Toddler Social & Emotional Assessment-Revised, SOV Dutch version of the Autism Quotient (AQ), JERI Joint Engagement Rating Inventory, BOSCC Brief Observation of Social Communication Change, ADOS-2 Autism Diagnostic Observation Schedule, N-CDI Dutch version of the MacArthur Communicative Development Inventory, Vineland Screener adapted version of the Vineland Adaptive Behaviour Scales, WEMWBS Warwick-Edinburgh Mental Well-being Scale, PSQ Parenting Stress Questionnaire (PSQ, in Dutch Opvoedingsbelastingsvragenlijst), BESTE the Rating Scale Satisfaction and Effect questionnaire, Tic-P Trimbos and iMTA questionnaire on Costs associated with Psychiatric illness
^aT1 is baseline; T2 is endpoint, eight weeks after baseline; T3 is follow-up, 24 weeks after endpoint
^bBoth the JERI and the BOSCC(parent) are assessed by the BEAR professional as part of the intervention (only at T1 and T2). At T3, both measurements are assessed by a researcher of the SCOPE project. All data will be coded by research assistants who are unaware of treatment allocation
^cThe BOSCC(clinician) is assessed by a professional examiner. Data will be coded by research assistants who are unaware of treatment allocation

ISSN: 1471-244X