Methods/Design: This protocol describes a two-arm, patient-level, single blind, superiority RCT comparing CT-PTSD (n=60) to TAU (n=60) in children and young people aged 8-17 years with a diagnosis of PTSD following multiple trauma exposure. The primary outcome is PTSD severity assessed using the Children’s Revised Impact of Event Scale (8-item version) at post-treatment (i.e. approximately five months post-randomisation). Secondary outcomes include structured interview assessment for PTSD, complex PTSD symptoms, depression and anxiety, overall functioning and parent-rated mental health. Mid-treatment and 11- and 29-month post-randomisation assessments will also be completed. Process-outcome evaluation will consider which mechanisms underpin or moderate recovery. Qualitative interviews with the young people, their families and their therapists will be undertaken. Cost-effectiveness of CT-PTSD relative to TAU will be also be assessed.
Ethics and dissemination: This trial protocol has been approved by a UK Health Research Authority (HRA) Research Ethics Committee (East of England – Cambridge South, 16/EE/0233). Findings will be disseminated broadly via peer-reviewed empirical journal articles, conference presentations, and clinical workshops.
Trial registration: ISRCTN, ISRCTN12077707. Registered 24th October 2016
|Accepted/In press - 18 Jun 2021