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

Internet-delivered cognitive therapy (iCT) for young people with post-traumatic stress disorder (PTSD) - early-stage randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16876240

Enrollment

Registered

2020-07-06

Start date

2020-07-14

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-traumatic stress disorder (PTSD) Mental and Behavioural Disorders Post-traumatic stress disorder

Interventions

Randomisation will be carried out by an independent clinical trials unit. Individual patient-level randomisation, with allocation in a 1:1 ratio, using minimisation methods employing two factors (gend

n = 17) This comprises therapist-supported online delivery of all components from our face-to-face Cognitive Therapy (CT) manual (Smith et al., 2010), including: psycho-education, reclaiming life, dev

n = 17) Patients allocated to WL will be asked to wait for 16 weeks before being offered iCT. If preferred, and if clinics are open and functioning as usual at the time, patients will be able to opt f

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Young people: 1. Aged 12-17 years old 2. Main presenting problem is PTSD (diagnosed using CAPS-5-CA) and there is a not a co-morbid problem that would preclude treatment of PTSD 3. PTSD symptoms relate to a single trauma 4. Participant has access to compatible smartphone or larger computing device (e.g. laptop, desktop computer, iPad) with internet access and to a safe and confidential space in which to engage in iCT 5. Participant speaks English to a level that allows therapy without the need for an interpreter, and reads English to a level that allows independent use of iCT Parents or carers: 1. Parent or carer of a young person who meets all of the inclusion criteria above and none of the exclusion criteria below 2. Parent or carer speaks English to a level that allows participation in therapy without the need for an interpreter, and reads English to a level that allows independent use of iCT 3. Parent or carer has access to compatible smartphone or larger computing device (e.g. laptop, desktop computer, iPad) with internet access

Exclusion criteria

Exclusion criteria: Young people: 1. Brain damage 2. Intellectual disability 3. Pervasive developmental disorder or neurodevelopmental disorder 4. Other psychiatric diagnosis that requires treatment before PTSD 5. Moderate to high risk to self 6. Ongoing trauma-related threat 7. Started treatment with psychotropic medication, or changed medication, within the last 2 months 8. Currently receiving another psychological treatment 9. Has already received trauma-focused CBT in relation to the same traumatic event that they are currently seeking treatment for Parents or carers: Parents or carers are not eligible if their son or daughter meets the exclusion criteria above. There are no additional exclusion criteria for parents or carers

Design outcomes

Primary

Measure	Time frame
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, con	—

Measure

Time frame

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, con

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Secondary

Measure	Time frame
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 _____ 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	—

Measure

Time frame

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 _____ 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

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Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 12, 2026