| Enrolment | Post-allocation | Close-out | |||||
|---|---|---|---|---|---|---|---|
| After consent | After randomisation | Treatment | 14 weeks after randomisation | 26 weeks after randomisation | |||
| Timepoint: | Baseline | Post-treatment | Follow-up | ||||
| Enrolment | Eligibility screen | X | |||||
| Informed consent | X | ||||||
| Allocation | X | ||||||
| Demographic information | X | ||||||
| Interventions | OSI | X | |||||
| C-TAU | X | ||||||
| Assessments | |||||||
| Child report | |||||||
| Symptom measure | RCADS-C | X | X | X | |||
| Functional impairment | CAIS-C | X | X | X | |||
| Adverse Events | AE Self-report | X | X | ||||
| Parent report | |||||||
| Symptom measures | RCADS-P | X | X | X | |||
| SCAS-P-8 | X | X | X | ||||
| Functional impairment | CAIS-P | X | X | X | |||
| ORS | X | X | X | ||||
| Co-morbid problems | SDQ-P | X | X | X | |||
| Pandemic Anxiety Scale | PAS | X | X | X | |||
| Treatment acceptability | Credibility and Expectation of Improvement scale | X | X | ||||
| Adverse events | AE Self-report | X | X | ||||
| Health economics | CSRI | X | X | X | |||
| EQ-5D-5L- P | X | X | X | ||||
| CHU-9D (YP proxy) | X | X | X | ||||
| CAIS-P | X | X | X | ||||
|
OSI+therapist support ARM ONLY Measures collected during treatment (parent only) |
RCADS-P | X | |||||
| SCAS-P-8 | X | ||||||
| CAIS-P | X | ||||||
| ORS | X | ||||||
| SRS | X | ||||||
| GBOs | X | ||||||
| Qualitative interviews | X (subgroup of participants interviewed once each between 14 and 26 weeks). | ||||||
| Therapist Logs | X | X | X | ||||