Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001018606
Ethics application status
Approved
Date submitted
1/09/2014
Date registered
22/09/2014
Date last updated
26/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Treating substance use and traumatic stress among adolescents: A pilot study
Scientific title
A preliminary examination of the Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure - Adolescent (COPE-A) intervention: Designed to reduce traumatic stress symptoms and substance use among adolescents aged 12-17yrs
Secondary ID [1] 285274 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-traumatic stress 292929 0
substance use 292930 0
Condition category
Condition code
Mental Health 293227 293227 0 0
Anxiety
Mental Health 293228 293228 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The COPE-A program consists of 16 weekly 60-90minute individual psychotherapy sessions and is designed for adolescent males or females who use any substances and have experienced any form of trauma. The COPE-A program comprises components of the gold standard treatments for adolescent PTSD and SUD including: i) trauma-focused cognitive behavioural therapy (CBT) for posttraumatic stress disorder (PTSD) and CBT for substance use; ii) establishing a trusting therapeutic relationship; iii) psychoeducation for PTSD and substance use; iv) enhancing stress management and problem solving skills; v) recognising and challenging unhelpful cognitions; and vi) exposure therapy for PTSD. COPE-A also includes three optional caregiver sessions that provide psychoeducation about substance use and trauma responses and a rationale for the adolescent program. A session is offered at the end-of-treatment to discuss PTSD and substance use relapse prevention strategies and aftercare.
Intervention code [1] 290161 0
Behaviour
Intervention code [2] 290224 0
Treatment: Other
Comparator / control treatment
All participants will receive the intervention (i.e., no control group).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293082 0
Acceptability of the COPE-A intervention will be measured using the Youth Client Satisfaction Questionnaire (YCSQ) and the Revised Helping Alliance Questionnaire (Haq-II).
Timepoint [1] 293082 0
At completion of the COPE-A treatment (i.e. at 16 weeks post-baseline)
Primary outcome [2] 293083 0
Feasibility of the COPE-A treatment will be measured as session attendance and treatment drop out. The therapist will also complete a session checklist at the end of each session to record which components were completed.
Timepoint [2] 293083 0
At completion of the COPE-A treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [1] 310303 0
Substance use will be measured using the CRAFFT Screening Tool
Timepoint [1] 310303 0
Assessed at baseline and post-treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [2] 310457 0
PTSD symptoms will be measured using the UCLA PTSD-Reaction Index
Timepoint [2] 310457 0
Assessed at baseline and post-treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [3] 310458 0
Psychological distress will be measured using the Kessler-10
Timepoint [3] 310458 0
Assessed at baseline and post-treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [4] 310459 0
Emotional, social, and behavioural functioning will be measured using the Strengths and Difficulties Questionnaire (SDQ)
Timepoint [4] 310459 0
Assessed at baseline and post-treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [5] 310460 0
Aggression will be measured using the Reactive Proactive Aggression Questionnaire and the Olweus Bullying Questionnaire
Timepoint [5] 310460 0
Assessed at baseline and post-treatment (i.e. at 16 weeks post-baseline)
Secondary outcome [6] 310552 0
Sessions will be recorded and reviewed to document therapeutic compliance.
Timepoint [6] 310552 0
At completion of the COPE-A treatment (i.e. at 16 weeks post-baseline)

Eligibility
Key inclusion criteria
(i) aged between 12-17 years,
(ii) substance use in the past month,
(iii) lifetime exposure to at least one traumatic event,
(iv) partial or full diagnosis of current PTSD.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) recent history of suicide or self-harm,
(ii) chronic psychosis,
(iii) organic or traumatic brain injury, or
(iv) ongoing trauma-related threat or ongoing unsupervised contact with the alleged perpetrator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/09/2014
Actual
17/10/2014
Date of last participant enrolment
Anticipated
Actual
17/10/2014
Date of last data collection
Anticipated
Actual
23/04/2015
Sample size
Target
10
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23548 0
2138 - Concord West

Funding & Sponsors
Funding source category [1] 289896 0
Government body
Name [1] 289896 0
Mental Health and Drug and Alcohol Office (MHDAO),
New South Wales Department of Health
Country [1] 289896 0
Australia
Primary sponsor type
Government body
Name
Mental Health and Drug and Alcohol Office (MHDAO)
Address
Locked Mail Bag 961
North Sydney NSW 2059
Australia
Country
Australia
Secondary sponsor category [1] 288582 0
None
Name [1] 288582 0
Address [1] 288582 0
Country [1] 288582 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291618 0
University of New South Wales HREC
Ethics committee address [1] 291618 0
Ethics committee country [1] 291618 0
Australia
Date submitted for ethics approval [1] 291618 0
Approval date [1] 291618 0
31/07/2014
Ethics approval number [1] 291618 0
HC14195

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51166 0
Dr Emma Barrett
Address 51166 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country 51166 0
Australia
Phone 51166 0
+61 02 9385 0164
Fax 51166 0
Email 51166 0
[email protected]
Contact person for public queries
Name 51167 0
Emma Barrett
Address 51167 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country 51167 0
Australia
Phone 51167 0
+61 02 9385 0164
Fax 51167 0
Email 51167 0
[email protected]
Contact person for scientific queries
Name 51168 0
Emma Barrett
Address 51168 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney, NSW 2052
Country 51168 0
Australia
Phone 51168 0
+61 02 9385 0164
Fax 51168 0
Email 51168 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.