{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Mills KL"],"funding":["National Health and Medical Research Council"],"pagination":["e043742"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC7705546"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["10(11)"],"pubmed_abstract":["<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-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)).<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>ACTRN12618000785202; Pre-reults.<h4>Protocol version</h4>Version 1, 31 July 2017."],"journal":["BMJ open"],"pubmed_title":["Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol."],"pmcid":["PMC7705546"],"funding_grant_id":["APP1127141"],"pubmed_authors":["Barrett E","Kihas I","Teesson M","Bendall S","Back SE","Peach N","Mills KL","Brady KT","Cassar J","Ross J","Schollar-Root O","Cobham VE","Perrin S"],"additional_accession":[]},"is_claimable":false,"name":"Randomised controlled trial of integrated trauma-focused psychotherapy for traumatic stress and substance use among adolescents: trial protocol.","description":"<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-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)).<h4>Methods and analysis</h4>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.<h4>Ethics and dissemination</h4>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.<h4>Trial registration number</h4>ACTRN12618000785202; Pre-reults.<h4>Protocol version</h4>Version 1, 31 July 2017.","dates":{"release":"2020-01-01T00:00:00Z","publication":"2020 Nov","modification":"2026-07-09T11:34:18.818Z","creation":"2025-06-01T01:54:41.218Z"},"accession":"S-EPMC7705546","cross_references":{"pubmed":["33257495"],"doi":["10.1136/bmjopen-2020-043742"]}}