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

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.

SUBMITTER: Mills KL

PROVIDER: S-EPMC7705546 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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

Mills Katherine L KL Barrett Emma E Back Sudie E SE Cobham Vanessa E VE Bendall Sarah S Perrin Sean S Brady Kathleen T KT Ross Joanne J Peach Natalie N Kihas Ivana I Cassar Joanne J Schollar-Root Olivia O Teesson Maree M

BMJ open 20201130 11

<h4>Introduction</h4>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-focu ...[more]

PMID: 33257495

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

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

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