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A randomised controlled trial of integrated psychological therapy for traumatic stress and substance use among adolescents: Trial protocol

Mills, Katherine ; Barrett, Emma ; Back, Sudie ; Cobham, Vanessa ; Bendall, Sarah ; Perrin, Sean LU orcid ; Brady, Kathleen ; Ross, Joanne ; Peach, Natalie and Kihas, Ivana , et al. (2020) In BMJ Open 10.
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... (More)
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. (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
PTSD, Substance use disorders, Children and Adolescents, Randomized Controlled Trial, CBT, Integrated Treatment
in
BMJ Open
volume
10
article number
e043742
publisher
BMJ Publishing Group
external identifiers
  • pmid:33257495
  • scopus:85097038292
ISSN
2044-6055
DOI
10.1136/bmjopen-2020-043742
project
Randomised controlled trial of an integrated cognitive-behavioural therapy for the treatment of co-occurring post traumatic stress disorder and substance use disorder in adolescents
language
English
LU publication?
yes
id
4d06820a-53d5-4ee1-a190-e94ea6656a35
date added to LUP
2020-10-27 20:48:22
date last changed
2022-06-28 23:45:37
@article{4d06820a-53d5-4ee1-a190-e94ea6656a35,
  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.}},
  author       = {{Mills, Katherine and Barrett, Emma and Back, Sudie and Cobham, Vanessa and Bendall, Sarah and Perrin, Sean and Brady, Kathleen and Ross, Joanne and Peach, Natalie and Kihas, Ivana and Cassar, Joanne and Schollar-Root, Olivia and Teesson, Maree}},
  issn         = {{2044-6055}},
  keywords     = {{PTSD; Substance use disorders; Children and Adolescents; Randomized Controlled Trial; CBT; Integrated Treatment}},
  language     = {{eng}},
  month        = {{11}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{A randomised controlled trial of integrated psychological therapy for traumatic stress and substance use among adolescents: Trial protocol}},
  url          = {{https://lup.lub.lu.se/search/files/87488182/Mills_et_al_2020_Trial_protocol_of_COPE_A_for_PTSD_and_Substance_Use_BMJ_Open.pdf}},
  doi          = {{10.1136/bmjopen-2020-043742}},
  volume       = {{10}},
  year         = {{2020}},
}