Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol. Issue 11 (30th November 2020)

• Record Type: Journal Article
• Authors: Mills, Katherine L; Barrett, Emma; Back, Sudie E; Cobham, Vanessa E; Bendall, Sarah; Perrin, Sean; Brady, Kathleen T; Ross, Joanne; Peach, Natalie; Kihas, Ivana; Cassar, Joanne; Schollar-Root, Olivia; Teesson, Maree
• Is Part Of: BMJ open. Volume 10:Issue 11(2020)
• Publication Date: 2020-11-30
• Subjects: substance misuse -- child & adolescent psychiatry -- anxiety disorders; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2020-043742
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : Introduction: 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)). Methods and analysis: 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. Ethics and dissemination: 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. Trial registration number: ACTRN12618000785202; Pre-reults. Protocol version: Version 1, 31 July 2017.