Online post-traumatic stress disorder treatment for young people and their carers

As this is an early-stage trial, the primary outcomes are feasibility outcomes and adherence metrics. Feasibility data on acceptability, compliance, retention, and delivery will be collected to enable an estimation of key parameters to inform a larger trial. This is in line with MRC guidance.

The following feasibility data on acceptability will be collected during the trial recruitment phase at the pre-intervention assessment and during the randomisation phase (June 2020- August 2021):
1. The total number of young people referred to the trial by (i) schools, (ii) Child and Adolescent Mental Health Services (CAMHS), or (iii) GP or self-referral
2. Number of young people screened in schools, and of these, the proportion who are considered to be eligible at school and proceed to a phone call with family
3. Number and proportion of young people in schools scoring above cut-off on a validated screening questionnaire (a score of ≥17 on the Children’s Revised Impact of Event Scale, CRIES-8); relative to the number of young people screened in schools
4. The number and proportion of young people in schools who score above cut-off on the CRIES-8 but decline further participation with the trial (relative to those scoring above cut-off)
5. The number and proportion of young people in schools who score above cut-off on CRIES-8 and consent to further assessment but are deemed ineligible at baseline assessment (relative to those deemed eligible at baseline assessment)
6. Number of assessment appointments offered to participants (via any referral route)
7. Number and proportion of assessment appointments attended by participants, relative to the number of appointments offered, reported by referral source (schools, CAMHS, GP referral, and self-referral)
8. Reasons for not attending assessment appointments (count and percentages) reported by referral source (schools, CAMHS, GP referral, and self-referral)
9. Number and proportion of young people who, at the baseline assessment, consent to participation in the trial (number consented / number attended assessment). Reasons for not consenting if known (count and percent)
10. Number and proportion of young people eligible for the trial after baseline assessment (number eligible at baseline interview/number assessed for eligibility at baseline interview)
11. Number of young people who are randomised, and proportion of consented young people who are randomised (number randomised / number consented)
12. Reasons for withdrawing from the trial if known
13. Number retained in study at 16 weeks (post-treatment) and at 38 weeks (follow-up), and proportions of those who start treatment that are retained (number retained / number started, and number retained/number randomised), by arm

Acceptability will also be gauged by carrying out qualitative interviews with young people about the acceptability of the research procedures, the assessment measures and views of randomisation at 16 weeks (post-treatment).

The following feasibility data on adherence, compliance and delivery will be collected in the iCT arm throughout the treatment phase (0-12 weeks):
14. Number of times logged into the programme per week and in total
15. Time spent logged in per week and in total
16. Number of modules completed in total and according to device used (phone, tablet, computer)
17. Number of therapist phone calls attended per week and in total, and the number of missed phone appointments
18. Time spent on phone calls per week and in total
19. Number of messages to/from therapist per week and in total
20. Number and proportion of young people who start treatment (number starting treatment/number randomised)
21. Number of weeks of therapy completed
22. Reasons for dropping out of treatment if known

Feasibility data on retention will be collected, including the reasons for withdrawing from the trial, if known and the number retained in the study at 16 weeks (post-treatment) and at 38 weeks (follow-up), and proportions of those who start treatment that are retained (number retained / number started, and number retained/number randomised), by arm.

The primary clinical outcome is the presence or absence of a diagnosis of post-traumatic stress disorder (PTSD) according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) published by the American Psychiatric Association, determined using a gold-standard semi-structured clinical interview: the Clinician-Administered PTSD Scale for DSM-5 - child and adolescent version (CAPS-5-CA), administered at 0 and 16 weeks after randomisation. This is a clinician-administered interview and will be administered by trained, reliable raters who are blind to treatment allocation.

Current secondary outcome measures as of 23/11/2021:

Young person completed outcome measures:
1. PTSD symptom severity measured using the CAPS-CA-5 at 0 (baseline) and 16 weeks post-randomisation (post intervention)
2. PTSD symptoms measured using the Child Post Traumatic Stress Scale (CPSS-5) and at 0, 16 and 38 weeks post randomisation (follow up)
3. Re-experiencing the traumatic event and avoidance measured using the Children’s Revised Impact of Event Scale - 8 item version (CRIES-8) at 0, 6, 16, and 38 weeks
4. Anxiety and depression measured using the Revised Children’s Anxiety and Depression Scale (RCADS-C) at 0, 16 and 38 weeks

Parent/carer completed outcome measures:
5. Emotional and behavioural problems measured using the Strength & Difficulties Questionnaire (SDQ-P) at 0, 16 and 38 weeks
6. Depression and anxiety measured using the Revised Children’s Anxiety and Depression Scale (RCADS-P) at 0, 16 and 38 weeks

Process measures
7. Negative trauma-related cognitions and appraisals measured using the Child Post Traumatic Cognitions Inventory (CPTCI) at 0, 6, 16 and 38 weeks
8. Memory quality measured using the Trauma Memory Quality Questionnaire (TMQQ) at 0, 6, 16 and 38 weeks
9. Rumination measured using the Trauma Related Rumination Questionnaire items at 0, 6, 16 and 38 weeks

Health economic measures
10. Health economics measured using the Child & Adolescent Service Use Schedule (CA-SUS) at 0, 16 and 38 weeks
11. Health-related quality of life using the Child Health Utility Index 9D (CHU-9D) measured at 0, 16 and 38 weeks

These outcomes will only be repeated at 38 weeks post-randomisation (follow-up) in the RCT for the active treatment arm

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Previous secondary outcome measures:

Young person completed outcome measures:
1. PTSD symptom severity measured using the CAPS-CA-5 at 0 (baseline) and 16 weeks post-randomisation (post intervention)
2. PTSD symptoms measured using the Child Post Traumatic Stress Scale (CPSS-5) and at 0, 16 and 38 weeks post randomisation (follow up)
3. Re-experiencing the traumatic event and avoidance measured using the Children’s Revised Impact of Event Scale - 8 item version (CRIES-8) at 0, 6, 16, and 38 weeks
4. Anxiety and depression measured using the Revised Children’s Anxiety and Depression Scale (RCADS-C) at 0, 16 and 38 weeks
5. Negative trauma-related cognitions and appraisals measured using the Child Post Traumatic Cognitions Inventory (CPTCI) at 0, 6, 16 and 38 weeks
6. Health-related quality of life using the Child Health Utility Index 9D (CHU-9D) measured at 0, 16 and 38 weeks

Parent/carer completed outcome measures:
7. Emotional and behavioural problems measured using the Strength & Difficulties Questionnaire (SDQ-P) at 0, 16 and 38 weeks
8. Depression and anxiety measured using the Revised Children’s Anxiety and Depression Scale (RCADS-P) at 0, 16 and 38 weeks
9. Health economics measured using the Child & Adolescent Service Use Schedule (CA-SUS) at 0, 16 and 38 weeks

These outcomes will only be repeated at 38 weeks post-randomisation (follow-up) in the RCT for the active treatment arm