Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol.

Post-traumatic stress disorder (PTSD) and substance use disorder frequently co-occur and tend to have their onset during adolescence. Although research has highlighted the importance of treating these disorders in an integrated fashion, there is a dearth of empirically validated integrated treatment options for adolescents with this comorbidity. This paper describes the study protocol for a randomised controlled trial (RCT) examining the efficacy of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents (Concurrent Treatment of PTSD and Substance Use Using Prolonged Exposure - Adolescent (COPE-A)), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)). A two-arm, parallel, single-blind RCT with blinded follow-up at 4 and 12 months poststudy entry will be conducted in Sydney, Australia. Participants (n~100 adolescents aged 12-18 years) and their caregivers (caregiver participation is optional) will be allocated to undergo either COPE-A or PCT (allocation ratio 1:1) using minimisation. Both therapies will be delivered individually by project psychologists over a maximum of 16 sessions of 60-90 min duration and will include provision of up to four 30 min optional caregiver sessions. The primary outcome will be between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for DSM-5. Ethical approval has been obtained from the human research ethics committees of the Sydney Children's Hospital Network (HREC/17/SCHN/306) and the University of Sydney (HREC 2018/863). Findings will be published in peer-reviewed journals and presented at scientific conferences. ACTRN12618000785202; Pre-reults. Version 1, 31 July 2017.

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Déclaration de conflit d'intérêts

Competing interests: KM is a recipient of grant funding and commissions from the National Health and Medical Research Council (NHMRC), Australian Government, NSW Health, Australian Rotary Health, Central Eastern Sydney Primary Health Network, the Sax Institute, Paul Ramsay Foundation, icare; receives royalties from Oxford University Press for the sale of the adult COPE manual; receives honorarium and payment for lectures, seminars and webinars; and is a member of the NSW Health Mental Health Review Tribunal. MT is a recipient of grant funding and commissions from the NHMRC, NSW Health, Sax Institute, Australian Government, Australian Rotary Health, Paul Ramsay Foundation and icare. She receives royalties from Oxford University Press for the sale of the adult COPE manual; receives honorarium and payment for lectures, seminars and webinars. She is a director of Climate Schools Pty Ltd, a company established to distribute evidence-based prevention resources to schools. SEB is a recipient of grant funding from the National Institutes of Health (NIH), Department of Defense and Veterans Affairs; receives royalties from Oxford University Press for the sale of the adult COPE manual; and receives honorarium and payment for lectures and grant reviews. EB is a recipient of grant funding from NSW Health, NHMRC, Australian Rotary Health, Sax Institute and icare, and receives payment for lectures, seminars and webinars. VC is a recipient of grant funding from the NHMRC, Australian Rotary Health and Children’s Hospital Foundation. She receives royalties from New Harbinger Press for the sale of a self-help book for parents of anxious children; and receives honorarium and payment for lectures, seminars and marking of theses. She is the first author of Fear-less Triple P and may in the future receive royalties from the dissemination of this resource. SB is a recipient of grant funding from the NHMRC, Movember Foundation, The Mental Illness Research Fund, Australian Rotary Health and the Telstra Foundation. She receives honorarium and payment for lectures, seminars and workshops. SP is a recipient of grant funding from National Institutes for Health Research and charitable organisations in the UK and Sweden and receives income from books/book chapters and workshops on cognitive–behavioural therapy for paediatric post-traumatic stress disorder and anxiety disorders. JR is a recipient of grant funding from the NHMRC. KTB is a recipient of grant funding and commissions from the NIH, the Department of Defense and the Veterans Administration Medical System; receives royalties from American Psychiatric Press; receives honorarium and payment for lectures, seminars and webinars. NP is a recipient of grant funding from Australian Rotary Health. IK is a recipient of grant funding from Australian Rotary Health.