Post Traumatic Stress DisorderOPTYCNCT03935035
Online PTSD Treatment for Young People and Carers - Case Series
A study testing internet-delivered Cognitive Therapy for PTSD (iCT) in people with Post Traumatic Stress Disorder, run by King's College London at 2 sites in United Kingdom.
Trial summary
Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- internet-delivered Cognitive Therapy for PTSD (iCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 1 Apr 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant is aged 12-17 years old
- Main presenting problem is PTSD and there is a not a co-morbid problem that would preclude treatment of PTSD.
- PTSD symptoms related to a single trauma
- Participant has access to compatible smartphone and larger computing device (e.g. laptop, desktop computer, iPad) with internet access.
- Participant is proficient in speaking and writing in the English language, sufficient to participate in treatment without an interpreter.
Who cannot join
- Brain damage assessed by clinical interview with parents / carers
- Intellectual disability assessed by clinical interview with parents / carers
- Pervasive developmental disorder or neurodevelopmental disorder assessed by clinical interview with parents / carers
- Other psychiatric diagnosis that requires treatment before PTSD, determined by clinical interview and questionnaires
- Moderate to high risk to self assessed in clinical interview
- Ongoing trauma-related threat assessed in clinical interview
Show all 9Show fewer
- Started treatment with psychotropic medication, or changed medication, within the last 2 months, assessed in clinical interview
- Currently receiving another psychological treatment, assessed in interview
- Have already received Trauma Focused CBT in relation to the same traumatic event that the young person is currently seeking treatment for.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
King's College London/ South London and Maudsley NHS Foundation Trust
London, SE5 8AF
Patrick Smith, 02078480506, patrick.smith@kcl.ac.uk
- Not yet recruiting
University of East Anglia/ Norfolk and Suffolk NHS Foundation Trust
Norwich, NR4 7TJ
Richard Meiser-Stedman, 01603 593601, r.meiser-stedman@uea.ac.uk
About this study
Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments.
The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people.
The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.
Read the detailed description
PTSD is prevalent among young people, and is distressing and impairing. Face-to-face trauma-focussed CBT (TFCBT) is an effective short-term therapy for PTSD in young people. The researchers previously developed Cognitive Therapy for PTSD (CT-PTSD) in children and young people, and have shown in 2 published RCTs that it is efficacious when delivered face-to-face. However, most young people with PTSD do not receive effective, evidence-based treatments. This is in part due to under-capacity in NHS CAMHS, and in part due to the burden and inconvenience to young people in attending face-to-face appointments in a clinic. In this project the researchers propose to make CT for PTSD widely available to young people by delivering the therapy via the internet, with therapist support. The rationale for this approach is that (1) young people will engage with internet-delivered therapy, and online therapies for other disorders such as depression have demonstrated efficacy in clinical trials; (2) effective online therapies for adults with PTSD have been developed and evaluated; (3) no online treatments for young people with PTSD have yet been developed.
An uncontrolled case series will be run with N=6 young patients. Young people who are referred to the South London and Maudsley NHS Foundation Trust CAMHS service, and who meet the eligibility criteria, will be invited to take part in the case series. After both the young person and their carer or parent have provided informed consent (or assent), they will complete several baseline assessment measures. These measures will be completed at a face-to-face meeting in the Tier 4 National and Specialist Trauma, Anxiety and Depression (TAD) NHS clinic, and online. The young person and family will meet the young person's therapist face-to-face at this initial assessment meeting. After assessment, the young person that will be treated remotely using iCT for up to 12 weeks.
This treatment will include regular (at least weekly) telephone contact with the therapist, and other contact with the therapist during the week using a messaging function within the iCT App. The young person will be asked to complete a mood rating and a brief 8-item questionnaire about PTSD symptoms once a week during treatment: this mirrors what happens during standard face-to-face care in the TAD NHS clinic. At mid treatment, the young person will be asked to complete one additional 25-item questionnaire about thoughts related to trauma. Risk monitoring including monitoring of adverse events will be carried out during weekly phone calls.
Post treatment, the young person will attend the TAD NHS clinic for a face-to-face clinical interview and will complete a questionnaire pack online. At this meeting, the young person will complete feedback ratings on the acceptability of the design of online treatment modules using 4 simple 0-10 scales (about the overall design appeal, ease-of-use, comprehension, and likelihood of recommending the program to a friend with similar problems). The young person will be interviewed about their experience of using the iCT program (an "exit interview"). Acceptability of the questionnaire battery will be assessed by asking young people to complete an end-of-treatment rating using a 0-100 scale. The young people's parents or carers will also take part in a clinical interview about the young person, will complete a questionnaire pack online, and will be invited to take part in an interview about their experience as a parent or carer of using the iCT program.
N=6 young people will be treated as part of this case series. Young people's and their parents' qualitative feedback on the acceptability of the iCT programme will be reported using data from the exit interviews and from the acceptability rating scales. Averse events during therapy will also be reported. Reliable Clinical Change on a standardised questionnaire of PTSD symptoms (the CPSS-5) will be reported as a preliminary signal of clinical effect. Reliable Clinical Improvement is shown by a reduction of 8 points on the CPSS-5. Acceptability of the outcome measures will be gauged by scrutinising completion rates.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- internet-delivered Cognitive Therapy for PTSD (iCT)
- Keywords
- adolescents, internet-delivered, online, young people, trauma, cognitive therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-delivered Cognitive Therapy for PTSD (iCT)Behavioural
Participants will receive 10 hours of Cognitive Therapy for PTSD over 12 weeks, with a baseline assessment at the beginning and follow up interview at the end of treatment. The treatment consists of online modules (9 core modules, 11 optional modules and parent/carer modules) and a weekly phone call with a qualified and trained therapist.
| Study group | Role | What they receive |
|---|---|---|
| internet-Cognitive Therapy for PTSD | Experimental | This is a single-arm study. All participants will receive the same therapist supported, internet-delivered intervention. Receives: Behavioral: internet-delivered Cognitive Therapy for PTSD (iCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.
Measured: Baseline
PTSD symptom scale: using the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.
Measured: post-intervention (at 4 months)
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
Measured: Baseline
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
Measured: Baseline
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Baseline
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
Measured: Mid-Treatment (at 6 weeks)
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
Measured: Post-treatment (at 4 months)
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
Measured: Post-treatment (at 4 months)
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Post-treatment (at 4 months)
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: 10-month follow up
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
Measured: 10-month follow up
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
Measured: 10-month follow up
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 1
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 2
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 3
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 4
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 5
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 6
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 7
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 8
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 9
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 10
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 11
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Measured: Week 12
Acceptability of iCT: Qualitative interviews
Qualitative interviews with N=6 young people, their carers, and their therapists.
Measured: Post-Treatment (at 4 months)
Acceptability of iCT: Likert Scales
Young people will be asked to complete ratings of acceptability on a scale from 0 to 100.
Measured: Post-Treatment (at 4 months)
Adherence to online intervention: time spent logged in to programme
Time spent logged on to online programme in seconds:minutes:hours according to the device used (smartphone, tablet or computer).
Measured: up to week 12
Adherence to online intervention: number of times logged on
The number of times a participant logs on to the online programme
Measured: up to week 12
Adherence to online intervention: number of modules completed
The number of online modules the young person completes during the 12 week intervention
Measured: up to week 12
Adherence to online intervention: number of phone calls between therapist and young person
The number of times the participant spoke to the therapist on the phone
Measured: up to week 12
Adherence to online intervention: time spent on phone calls with the therapist
Time spent on phone calls with the therapist in seconds:minutes:hours
Measured: up to week 12
Adherence to online intervention: number of messages exchanged with the therapist
Number of messages exchanged between the patient and the therapist
Measured: up to week 12
Secondary outcomes (9)
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item self-report questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: Baseline
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item parent rated questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS-P can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: Baseline
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item self-report questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: post-treatment (at 4 months)
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item parent rated questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS-P can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: post-treatment (at 4 months)
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item self-report questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: at 10-month follow up
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
A 47-item parent rated questionnaire. Items are rated on a 4-point scale (0= never, 1 = sometimes, 2= often, 3 = always). The RCADS-P can be scored using spreadsheets available from the developer. The young person's school year must be entered (enter the year number according to the US grade system) and a 't-score' is calculated. A t-score of 70 or more is considered clinically significant. The greater the t-score the greater the symptoms.
Measured: at 10-month follow up
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Parent rated questionnaire with 25 items. Items are rated on a 3-point scale (0=not true, 1=somewhat true, 2= certainly true). There are 5 sub-scales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. A total difficulties score of 17 or above is considered clinically significant. The greater the total score, the greater the difficulties experienced.
Measured: Baseline
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Parent rated questionnaire with 25 items. Items are rated on a 3-point scale (0=not true, 1=somewhat true, 2= certainly true). There are 5 sub-scales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. A total difficulties score of 17 or above is considered clinically significant. The greater the total score, the greater the difficulties experienced.
Measured: post-treatment (at 4 months)
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Parent rated questionnaire with 25 items. Items are rated on a 3-point scale (0=not true, 1=somewhat true, 2= certainly true). There are 5 sub-scales each with scores ranging from 0-10. The total difficulties score is calculated by summing 4 of the sub-scales to give a score between 0-40. A total difficulties score of 17 or above is considered clinically significant. The greater the total score, the greater the difficulties experienced.
Measured: at 10-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2019
- Study start1 Apr 2019
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Uncontrolled case series
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South London and Maudsley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Patrick Smith, PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935035
- Sponsor's protocol ID
- MR/P017355/1
- Acronym
- OPTYC
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9.
PubMed 11501254Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
PubMed 11699809McKinnon A, Smith P, Bryant R, Salmon K, Yule W, Dalgleish T, Dixon C, Nixon RD, Meiser-Stedman R. An Update on the Clinical Utility of the Children's Post-Traumatic Cognitions Inventory. J Trauma Stress. 2016 Jun;29(3):253-8. doi: 10.1002/jts.22096. Epub 2016 May 18.
PubMed 27191657Perrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
Pynoos, R. S., Weathers, F. W., Steinberg, A. M., Marx, B. P., Layne, C. M., Kaloupek, D. G., Schnurr, P. P., Keane, T. M., Blake, D. D., Newman, E., Nader, K. O., & Kriegler, J. A. (2015). Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online PTSD Treatment for Young People and Carers - Case Series
- ClinicalTrials.gov ID
- NCT03935035
- Acronym / sponsor ID
- OPTYC / MR/P017355/1
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- adolescents, internet-delivered, online, young people, trauma, cognitive therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Medical Research Council, South London and Maudsley NHS Foundation Trust
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 2 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Post Traumatic Stress Disorder (PTSD) is prevalent and impairing in children and young people. Effective face to face treatments exist, including Cognitive Therapy for PTSD (CT-PTSD), developed by the researchers' group. However, few young people access effective treatments.
The researchers are therefore developing a website and smart-phone App that will improve accessibility of this treatment by allowing trained therapists to deliver CT-PTSD over the internet (iCT) to young people (12-17 years old) with PTSD. This study aims to provide an initial evaluation of iCT. This will be done by running an uncontrolled case series with 6 young people.
The objectives of the case series are to: to gauge acceptability of the programme to young people, carers, and therapists; to measure adherence to the programme; to test the battery of measures for acceptability; and to obtain estimates of clinical change.
Detailed description
PTSD is prevalent among young people, and is distressing and impairing. Face-to-face trauma-focussed CBT (TFCBT) is an effective short-term therapy for PTSD in young people. The researchers previously developed Cognitive Therapy for PTSD (CT-PTSD) in children and young people, and have shown in 2 published RCTs that it is efficacious when delivered face-to-face. However, most young people with PTSD do not receive effective, evidence-based treatments. This is in part due to under-capacity in NHS CAMHS, and in part due to the burden and inconvenience to young people in attending face-to-face appointments in a clinic. In this project the researchers propose to make CT for PTSD widely available to young people by delivering the therapy via the internet, with therapist support. The rationale for this approach is that (1) young people will engage with internet-delivered therapy, and online therapies for other disorders such as depression have demonstrated efficacy in clinical trials; (2) effective online therapies for adults with PTSD have been developed and evaluated; (3) no online treatments for young people with PTSD have yet been developed.
An uncontrolled case series will be run with N=6 young patients. Young people who are referred to the South London and Maudsley NHS Foundation Trust CAMHS service, and who meet the eligibility criteria, will be invited to take part in the case series. After both the young person and their carer or parent have provided informed consent (or assent), they will complete several baseline assessment measures. These measures will be completed at a face-to-face meeting in the Tier 4 National and Specialist Trauma, Anxiety and Depression (TAD) NHS clinic, and online. The young person and family will meet the young person's therapist face-to-face at this initial assessment meeting. After assessment, the young person that will be treated remotely using iCT for up to 12 weeks.
This treatment will include regular (at least weekly) telephone contact with the therapist, and other contact with the therapist during the week using a messaging function within the iCT App. The young person will be asked to complete a mood rating and a brief 8-item questionnaire about PTSD symptoms once a week during treatment: this mirrors what happens during standard face-to-face care in the TAD NHS clinic. At mid treatment, the young person will be asked to complete one additional 25-item questionnaire about thoughts related to trauma. Risk monitoring including monitoring of adverse events will be carried out during weekly phone calls.
Post treatment, the young person will attend the TAD NHS clinic for a face-to-face clinical interview and will complete a questionnaire pack online. At this meeting, the young person will complete feedback ratings on the acceptability of the design of online treatment modules using 4 simple 0-10 scales (about the overall design appeal, ease-of-use, comprehension, and likelihood of recommending the program to a friend with similar problems). The young person will be interviewed about their experience of using the iCT program (an "exit interview"). Acceptability of the questionnaire battery will be assessed by asking young people to complete an end-of-treatment rating using a 0-100 scale. The young people's parents or carers will also take part in a clinical interview about the young person, will complete a questionnaire pack online, and will be invited to take part in an interview about their experience as a parent or carer of using the iCT program.
N=6 young people will be treated as part of this case series. Young people's and their parents' qualitative feedback on the acceptability of the iCT programme will be reported using data from the exit interviews and from the acceptability rating scales. Averse events during therapy will also be reported. Reliable Clinical Change on a standardised questionnaire of PTSD symptoms (the CPSS-5) will be reported as a preliminary signal of clinical effect. Reliable Clinical Improvement is shown by a reduction of 8 points on the CPSS-5. Acceptability of the outcome measures will be gauged by scrutinising completion rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Uncontrolled case series
| Arm | Type | Receives |
|---|---|---|
| internet-Cognitive Therapy for PTSD | Experimental | Behavioral: internet-delivered Cognitive Therapy for PTSD (iCT)This is a single-arm study. All participants will receive the same therapist supported, internet-delivered intervention. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant is aged 12-17 years old
- Main presenting problem is PTSD and there is a not a co-morbid problem that would preclude treatment of PTSD.
- PTSD symptoms related to a single trauma
- Participant has access to compatible smartphone and larger computing device (e.g. laptop, desktop computer, iPad) with internet access.
- Participant is proficient in speaking and writing in the English language, sufficient to participate in treatment without an interpreter.
Key exclusion criteria (9 listed)
- Brain damage assessed by clinical interview with parents / carers
- Intellectual disability assessed by clinical interview with parents / carers
- Pervasive developmental disorder or neurodevelopmental disorder assessed by clinical interview with parents / carers
- Other psychiatric diagnosis that requires treatment before PTSD, determined by clinical interview and questionnaires
- Moderate to high risk to self assessed in clinical interview
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| internet-delivered Cognitive Therapy for PTSD (iCT)Participants will receive 10 hours of Cognitive Therapy for PTSD over 12 weeks, with a baseline assessment at the beginning and follow up interview at the end of treatment. The treatment consists of online modules (9 core modules, 11 optional modules and parent/carer modules) and a weekly phone call with a qualified and trained therapist. | Behavioural | internet-Cognitive Therapy for PTSD |
Primary outcome
PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
Time frame: Baseline
Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.
PTSD symptom scale: using the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
Time frame: post-intervention (at 4 months)
Clinician Administered. The time period covered is the past month. Items are rated 0-4 based on frequency and severity of symptoms (0=absent, 1= mild, 2=moderate, 3 = severe, 4 = extreme). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" (if the symptom severity is rated 2 or higher) or "absent" (rated 0 or 1). Items pertain to the 4 criterion of PTSD outlined in the DSM-V; criterion B (items 1-5), criterion C (items 6-7), criterion D (items 8-14) and criterion E (items 15-20). PTSD may be diagnosed if the young person has at least one criterion B, one criterion C, two criterion D and two criterion E symptoms and if the disturbance has lasted for more than one month and causes clinically significant distress or functional impairment.
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
Time frame: Baseline
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
Time frame: Baseline
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
Time frame: Baseline
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
Time frame: Mid-Treatment (at 6 weeks)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
Time frame: Post-treatment (at 4 months)
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
Time frame: Post-treatment (at 4 months)
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
Time frame: Post-treatment (at 4 months)
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
Time frame: 10-month follow up
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
Time frame: 10-month follow up
A self-report questionnaire with 27 items relating to the past one month. The first 20 items evaluate the frequency and severity of PTSD symptoms. Items are rated on a 5-point scale (0= not at all, 1 = <once a week, 2= 2-3 times per week, 3 = 4-5 times a week, 4 = 6 or more times per week). The final 7 items evaluate functional impairment an are scored 1 ('Yes') or 0 ('No') with scores ranging from 0-7, greater scores indicate greater impairment. From the first part of the CPSS scores can range between 0-80 with higher scores indicating greater symptom severity. A score of 31 or higher indicates PTSD.
PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
Time frame: 10-month follow up
A self-report questionnaire with 10 items. The CPTCI measures PTSD symptoms since the traumatic event occurred, on a scale of 1-4 (1= don't agree at all, 2 = don't agree a bit, 3 = agree a bit, 4 = agree a lot). Scores range from 0-40 with greater scores indicating greater symptom severity. A total score of 16 or above is considered clinically significant.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 1
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 2
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 3
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 4
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 5
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 6
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 7
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 8
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 9
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 10
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 11
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
Time frame: Week 12
A self-report questionnaire with 8 items (4 measuring intrusions, 4 measuring avoidance). The items assess symptoms over the past 7 days on a 4-point scale (0=not at all, 1= rarely, 3=sometimes, 5=often). Intrusion sub-scale is the sum of items 1,3,6 and 7. Avoidance sub-scale is the sum of items 2,4,5 and 8. Scores can range from 0-40 with greater scores indicating greater symptom severity. A total score of 17 or higher indicates PTSD.
Acceptability of iCT: Qualitative interviews
Time frame: Post-Treatment (at 4 months)
Qualitative interviews with N=6 young people, their carers, and their therapists.
Acceptability of iCT: Likert Scales
Time frame: Post-Treatment (at 4 months)
Young people will be asked to complete ratings of acceptability on a scale from 0 to 100.
Adherence to online intervention: time spent logged in to programme
Time frame: up to week 12
Time spent logged on to online programme in seconds:minutes:hours according to the device used (smartphone, tablet or computer).
Adherence to online intervention: number of times logged on
Time frame: up to week 12
The number of times a participant logs on to the online programme
Adherence to online intervention: number of modules completed
Time frame: up to week 12
The number of online modules the young person completes during the 12 week intervention
Adherence to online intervention: number of phone calls between therapist and young person
Time frame: up to week 12
The number of times the participant spoke to the therapist on the phone
Adherence to online intervention: time spent on phone calls with the therapist
Time frame: up to week 12
Time spent on phone calls with the therapist in seconds:minutes:hours
Adherence to online intervention: number of messages exchanged with the therapist
Time frame: up to week 12
Number of messages exchanged between the patient and the therapist
9 secondary outcomes
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: Baseline
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: Baseline
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: post-treatment (at 4 months)
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: post-treatment (at 4 months)
Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: at 10-month follow up
Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
Time frame: at 10-month follow up
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Time frame: Baseline
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Time frame: post-treatment (at 4 months)
Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
Time frame: at 10-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Background: PubMed 11501254Foa EB, Johnson KM, Feeny NC, Treadwell KR. The child PTSD Symptom Scale: a preliminary examination of its psychometric properties. J Clin Child Psychol. 2001 Sep;30(3):376-84. doi: 10.1207/S15374424JCCP3003_9.
- Background: PubMed 11699809Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.
- Background: PubMed 27191657McKinnon A, Smith P, Bryant R, Salmon K, Yule W, Dalgleish T, Dixon C, Nixon RD, Meiser-Stedman R. An Update on the Clinical Utility of the Children's Post-Traumatic Cognitions Inventory. J Trauma Stress. 2016 Jun;29(3):253-8. doi: 10.1002/jts.22096. Epub 2016 May 18.
- BackgroundPerrin, S., Meiser-Stedman, R., & Smith, P. (2005). The Children's Revised Impact of Event Scale (CRIES): validity as a screening instrument for PTSD. Behavioural and Cognitive Psychotherapy, 33(4), 487-498.
- BackgroundPynoos, R. S., Weathers, F. W., Steinberg, A. M., Marx, B. P., Layne, C. M., Kaloupek, D. G., Schnurr, P. P., Keane, T. M., Blake, D. D., Newman, E., Nader, K. O., & Kriegler, J. A. (2015). Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version.
- Link to Perrin, Meiser-Stedman, \& Smith, (2005). The Children's Revised Impact of Event Scale (CRIES): validity as a screening instrument for PTSDLink provided by the sponsor.
- Link to Pynoos et al., (2015). Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent VersionLink provided by the sponsor.
- Chorpita, B. F., Ebesutani, C., \& Spence, S. H. (2014). Revised children's anxiety and depression scale user's guide. Unpublished Users Guide, University of California, Los Angeles. http://www. childfirst. ucla. edu/RCADSUsersGuide20140711.pdf.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Smith, PhD principal investigator
King's College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internet-delivered Cognitive Therapy for PTSD (iCT) in people with Post Traumatic Stress Disorder, run by King's College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick A Smith, PhD (02078480506 ext. 0506, patrick.smith@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015) (time frame: Baseline). The study lists 32 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03935035, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.