Months post-randomisation | 0 | 0 | 1 | 2 |
---|---|---|---|---|
Time point | Telephone/videoconference screening | Baseline | Mid-intervention (4 weeks) | Primary end point (8–10 weeks) |
Consent | Â | R (P+A) | Â | Â |
Randomisation | Â | R | Â | Â |
PHQ-A | Â | R (A/P) | A/P | R (A/P) |
CAIDS-Q | Â | R (A/P) | Â | Â |
RCADS | Â | R (A/P) | Â | R (A/P) |
Screening for eligibility | R (P) | R | Â | Â |
SDQ & DAWBA (conducted post telephone/videoconference screen & prior to baseline) | P | Â | Â | Â |
CGI-S/I | Â | R (A/P) | Â | R (A/P) |
EQ-5D-Y | Â | R (A) | Â | R (A) |
EQ-5D-Y (proxy version) | Â | R (P) | Â | R (P) |
Demographics | Â | R (A/P) | Â | Â |
Concomitant interventions | Â | R (A/P)* | Â | R (A/P) |
Adverse events | Â | R (A/P) | A/P | R (A/P) |
Interview (process evaluation) | Â | Â | Â | R |