Table 2.

Study procedures

Study procedure	Visit 1	Visit 2	Randomisation automated system	Visit 3 (baseline) 4–14 weeks post-care entry	Visit 4 (follow-up) 15 months post-care entry	Visit 5 (final follow-up) 2.5 years post-randomisation	Interview or focus group
Provision of study information	✓	✓
Consent		✓
Randomisation			✓
SDQ To be completed for children aged 2 and over, according to age of child: • 2–4y, 4–17y				✓	✓	✓
PIR-GAS To be completed for all children				✓	✓	✓
ITSEA To be completed for children aged 12–35 months				✓	✓
DAI To be completed if child 12 months and over				✓	✓	✓
DAWBA To be completed for children aged 2 and over, according to age of child: • 2–4y, 4–17y				✓	✓	✓
Service use questionnaire To be completed for all children				✓	✓	✓
TIMB To be completed for all children				✓	✓	✓
Observational Checklist for RAD To be completed if child 12 months and over				✓	✓(if not collected V3)
Cognitive assessment • WPPSI III—30–47 months, • WPPSI III—48–87 months • WISC IV—children + 87 months				✓ (optional)	✓ (optional)	✓
PedsQL To be completed for all children, according to age of child: • 1–12 m, 13–24 m, 2–4y, 5–7y				✓	✓	✓
RPQ To be completed if child 12 months and over				✓	✓	✓
Data linkage						✓
Parent/carer qualitative interview/focus group							✓