Table 1 Aims, outcome measures and progression criteria
| Â | Aims | Measure | Timepoint | Progression criteria |
|---|---|---|---|---|
a. | Identify appropriate clinical outcome and economic measures for a subsequent definitive trial | Clinical outcomes: ADIS-C/P/KSADS-C/P (or DAWBA and ADIS-panic section) (diagnosis and CSR) | Routine assessment/pre-randomisation | Appropriate measures identified |
Clinical outcomes: PDSS-A, RCADS-C/P, CAIS-C/P Health economic measures: CSRI, EQ-5D, CHU-9D | Enrolment/pre-treatment | |||
Clinical outcomes: PDSS-A, RCADS-C/P, CAIS-C/P Health economic measures: CSRI, EQ-5D, CHU-9D | Post-treatment | |||
Clinical outcomes: ADIS-C/P/KSADS-C/P (or DAWBA & ADIS-panic section) (diagnosis and CSR), CGI-I, PDSS-A, RCADS-C/P, CAIS-C/P Health economic measures: CSRI, EQ-5D, CHU-9D | 3-month follow-up | |||
b. | Explore the acceptability of the treatments and trial procedures | Credibility and expectation of improvement scale-C/P | Enrolment | No serious concerns raised |
ESQ-C/P | Post-treatment and 3-month follow-up | No serious concerns raised | ||
Qualitative interview (young people, parent/carers, clinicians) | Post-treatment/3-month follow-up | No serious concerns raised | ||
c. | Establish likely recruitment rates | Screening logs maintained by site n = Approached n= Accepting n = Declining Reasons (coded) for decline of study invitation | At study entry and ongoing through study | Green: ≥ 30 participants recruited; ≥ 80% eligible participants agree to randomisation |
Amber: 20–29 participants recruited; 70–79% eligible participants agree to randomisation | ||||
Red:Â < 20 young people are recruited; < 70% eligible participants agree to randomisation | ||||
d. | Establish the likely rate of treatment drop-out | Number withdrawing from treatment | Ongoing through study | Green: Treatment drop-out rate of ≤ 20% in both treatment arms |
Amber: Treatment drop-out rate of 21–30% in both treatment arms | ||||
Red:Â Treatment drop-out rate of > 30% in both treatment arms | ||||
e. | Establish likely retention to research assessments post-treatment and at 3-month follow-up | Number of completed assessments - PDSS-A - All other clinical and health economic outcome measures | Ongoing through study | Green: ≥ 80% of participants will complete the PDSS-A at post-treatment and 3-month follow-up assessment |
Amber: 70–79% of participants complete the PDSS-A at post-treatment and 3-month follow-up assessment | ||||
Red:Â < 70% of participants complete the PDSS-A at post-treatment and 3-month follow-up assessment | ||||
f. | Explore retention to a brief 12-month follow-up | Clinical outcomes: PDSS-A | 12-months follow-up | No set criteria |
g. | Establish if brief cognitive therapy can be delivered so that it is clearly distinct from a general form of CBT, with high levels of fidelity by practitioners in both arms | Therapy contents checklist | Each clinical session | Green: In both arms, sessions contain ≥ 80% ‘allowable’ features of the specific intervention |
Amber: In both arms, sessions contain 70–79% ‘allowable’ features of the specific intervention | ||||
Red: In both arms, sessions contain < 70% ‘allowable’ features of the specific intervention | ||||
h. | Conduct exploratory analyses of possible outcomes for the two treatments including changes in anxiety symptoms, diagnostic status, quality of life and healthcare resource use | Clinical outcomes: PDSS-A, RCADS-C/P, CAIS-C/P Health economic measures: CSRI, EQ-5D, CHU-9D | Post-treatment | Not applicable |
Clinical outcomes: ADIS-C/P/KSADS-C/P (diagnosis and CSR), CGI-I, PDSS-A, RCADS-C/P, CAIS-C/P Health economic measures: CSRI, EQ-5D, CHU-9D | 3-month follow-up | Not applicable | ||
Clinical outcomes: PDSS-A | 12-months follow-up | Not applicable | ||
i. | Describe negative impacts of the treatments and the trial procedures (to young people, their parents/carers and clinicians) | Adverse events | Ongoing through study | Serious negative impacts do not occur because of participation in the trial |
Qualitative interview (young people, parent/carers, clinicians) | Post-treatment/3-month follow-up | No serious impacts raised | ||
j. | Explore young people’s outcomes on measures of symptom and functional impairment | Symptom measures: PDSS-A, RCADS-C/P, CAIS-C/P Functional impairment: ORS | Post-treatment | Not applicable |
Symptom measures: PDSS-A, RCADS-C/P, CAIS-C/P Functional impairment: ORS | 3-month follow-up | Not applicable | ||
Clinical outcomes: PDSS-A | 12-month follow-up | Not applicable |