Clinical trial NCT03935035: Online PTSD Treatment for Young People and Carers - Case Series
Official title: Online PTSD Treatment for Young People and Carers - Case Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: adolescents
internet-delivered
online
young people
trauma
cognitive therapy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Medical Research Council
name: South London and Maudsley NHS Foundation Trust
First posted: 2019-05-02
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uncontrolled case series
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: PTSD symptom scale: Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
timeFrame: Baseline
measure: PTSD symptom scale: using the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA-5, Pynoos et al., 2015)
timeFrame: post-intervention (at 4 months)
measure: PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
timeFrame: Baseline
measure: PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
timeFrame: Baseline
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
timeFrame: Baseline
measure: PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
timeFrame: Mid-Treatment (at 6 weeks)
measure: PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
timeFrame: Post-treatment (at 4 months)
measure: PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
timeFrame: Post-treatment (at 4 months)
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
timeFrame: Post-treatment (at 4 months)
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al 2005)
timeFrame: 10-month follow up
measure: PTSD symptoms: Child Post Traumatic Stress Scale (CPSS-5; Foa et al. 2001)
timeFrame: 10-month follow up
measure: PTSD symptoms: Child Post Traumatic Cognitions Inventory (CPTCI, McKinnon et al 2016)
timeFrame: 10-month follow up
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 1
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 2
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 3
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 4
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 5
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 6
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 7
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 8
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 9
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 10
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 11
measure: PTSD symptoms: Children's Revised Impact of Event Scale (CRIES; Perrin et al., 2005)
timeFrame: Week 12
measure: Acceptability of iCT: Qualitative interviews
timeFrame: Post-Treatment (at 4 months)
measure: Acceptability of iCT: Likert Scales
timeFrame: Post-Treatment (at 4 months)
measure: Adherence to online intervention: time spent logged in to programme
timeFrame: up to week 12
measure: Adherence to online intervention: number of times logged on
timeFrame: up to week 12
measure: Adherence to online intervention: number of modules completed
timeFrame: up to week 12
measure: Adherence to online intervention: number of phone calls between therapist and young person
timeFrame: up to week 12
measure: Adherence to online intervention: time spent on phone calls with the therapist
timeFrame: up to week 12
measure: Adherence to online intervention: number of messages exchanged with the therapist
timeFrame: up to week 12
Secondary outcomes:
measure: Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: Baseline
measure: Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: post-treatment (at 4 months)
measure: Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: post-treatment (at 4 months)
measure: Revised Children's Anxiety and Depression Scale (RCADS-C; Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: at 10-month follow up
measure: Revised Children's Anxiety and Depression Scale (RCADS-P Chorpita & Ebesutani 2014): Measure of young person's anxiety and depression symptoms
timeFrame: at 10-month follow up
measure: Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
timeFrame: Baseline
measure: Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
timeFrame: post-treatment (at 4 months)
measure: Strength & Difficulties Questionnaire (SDQ-P; Goodman, 2001): Measure of young person's emotional and behavioural difficulties
timeFrame: at 10-month follow up
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London/ South London and Maudsley NHS Foundation Trust
city: Norwich
country: United Kingdom
facility: University of East Anglia/ Norfolk and Suffolk NHS Foundation Trust
Study officials:
affiliation: King's College London
name: Patrick Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Goodman 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.
citation: McKinnon 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.
citation: Perrin, 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.
citation: 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.