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 | ✓ | ||||||