Post-traumatic stress disorder Mental and Behavioural Disorders
Conditions
Interventions
A remote randomisation service will assign allocation to groups coordinated by the Norwich Clinical Trials Unit. Allocation is by pre-set lists of permuted blocks with randomly distributed block sizes
and site (i.e. NHS Trust from where the participant was recruited).
Intervention group: Participants receive treatment with CT-PTSD (Cognitive therapy-PTSD). This involves participating in up to 15 t
Sponsors
University of East Anglia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children and adolescents aged 8-17 years 2. Experiencing high levels of PTSD symptoms (scoring 17 or above on the CRIES-8) 3. Diagnosis of PTSD (as defined by DSM-5) following multiple trauma exposure
Exclusion criteria
Exclusion criteria: 1. Any change of prescribed psychiatric medication within the past two months 2. PTSD symptoms only related to a single traumatic event 3. Developmental/neurodevelopmental disorder (e.g. autism) 4. Diagnosis of intellectual disability 5. Primary psychiatric diagnosis that warrants treatment ahead of PTSD (e.g. psychosis, severe depression, suicidal behaviour) 6. Inability to speak and understand English 7. On-going threat (e.g. living with an abuser) or safeguarding issue 8. Strong likelihood of being unable to complete treatment (e.g. imminent house move or placement move) or 9. History of organic brain damage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of symptoms of PTSD are measured using the Child Revised Impact of Event Scale (CRIES-8) completed at baseline and at 2.5, 5 and 11 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PTSD severity is measured using the Children’s PTSD Symptom Scale for DSM-5, interviewer version (CPSS-I-5), at baseline, 5 and 11 months 2. Self-reported PTSD severity is measured using the Child and Adolescent Trauma Screen (CATS), with additional items addressing dissociation and complex PTSD symptoms at baseline, 2.5, 5 and 11 months. 3. Anxiety and depression are is measured using the Revised Child Anxiety and Depression Scale (RCADS) at baseline, 5 and 11 months 4. Suicidal ideation is measured using selected items from the Mood and Feelings Questionnaire (MFQ) at baseline,5 and 11 months 5. Irritability is measured using the Affective Reactivity Index (ARI; child and parent-report versions) at baseline, 5 and 11 months 6. Child’s overall severity and functioning is measured using the Children’s Global Assessment Scale at baseline, 5 and 11 months 7. Parent reported mental health and well-being measured using the Strengths and Difficulties Questionnaire at baseline, 5 and 11 months 8. Personality traits are measured using the McLean Screening Instrument (caregiver version) at baseline, 5 and 11 months 9. Quality of life is measured using the Youth version of EuroQol EQ-5D (EQ-5D-Y) at baseline, 5 and 11 months Health economic outcomes: 1. Resource use is measured using the Child and Adolescent Service Use Schedule (CA-SUS) at baseline, 5 and 11 months 2. Views of the young people, their families and clinicians will be captured using qualitative interviews when therapy has been concluded (for participants and family members) or after the trial data collection has concluded (for service managers and commissioners). 3. Cost-effectiveness of CT-PTSD will be assessed using CA-SUS and EQ-5DY (as above) and additional data will be collected directly from clinicians and service records regarding CT-PTSD and TAU contact time and indirect time. If resources allow, an additional 29 month follow up assessment will take place, where the CRIES-8, CPSS-I-5, CATS, RCA | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed