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

Abstract

IntroductionPost-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 analysisA 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 disseminationEthical 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 numberACTRN12618000785202; Pre-reults.Protocol versionVersion 1, 31 July 2017.

A systematic review and meta-analysis of psychological interventions for comorbid post-traumatic stress disorder and substance use disorder

“…Among children and adolescent populations, we only included one pilot study with female adolescents (Najavits et al, 2006 ). We identified one other adolescent-focused RCT evaluating a family therapy-based intervention (Danielson et al, 2020 ) that did not fulfil our diagnostic inclusion criteria, and a protocol for one study which is currently under way (Mills et al, 2020 ).…”

Integrated Trauma-Focused Psychotherapy for Traumatic Stress and Substance Use: Two Adolescent Case Studies

“…There is an overall dearth of empirically validated integrated treatment options for adolescents with PTSD and SUD (Danielson et al, 2010, 2012, 2020; Fortuna et al, 2018; Najavits et al, 2006). We sought to address this gap by conducting a world-first randomised controlled trial which compares a novel integrated trauma-focused psychotherapy for co-occurring PTSD and SUD among adolescents, called COPE-A (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure for Adolescents) (Mills et al, 2020), with a supportive counselling control condition (person-centred therapy) (Kay-Lambkin et al, 2011) (Trial Registration number: ACTRN12618000785202).…”

“…Participants completed a battery of assessments at baseline, 4-month follow-up and 12-month follow-up (Mills et al, 2020). These included diagnostic measures such as the Clinician Administered PTSD Scale for DSM-5-Child/Adolescent Version (CAPS-CA-5) (Pynoos et al, 2015) and the Diagnostic Interview Schedule for Children-Version Five (DISC-5) (Fisher, 2020).…”

Integrated care – panacea or white elephant? A review of integrated care approaches in Australia over the past two decades

“…The COPE intervention provides evidence that concurrent treatment of PTSD and substance use disorder is both safe and efficacious, challenging the myth that abstinence is required prior to addressing trauma (Mills et al , 2012). Important next steps in advancing this evidence base are underway in Australia, with implementation in a routine clinical setting at Turning Point in Melbourne, and a current trial in an adolescent population run by the Matilda Centre (Mills et al , 2020). However, the overall evidence base remains limited for complex co-occurring disorders, particularly for integrated interventions targeting substance use concurrently with severe mental illness.…”