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Trial registered on ANZCTR


Registration number
ACTRN12618000866202
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
22/05/2018
Date last updated
22/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a modified dialectical behaviour therapy (DBT) group program in treating adolescents and young adults experiencing substance misuse
Scientific title
Evaluating the effectiveness of a modified dialectical behaviour therapy (DBT) group program in treating adolescents and young adults experiencing substance misuse
Secondary ID [1] 294416 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Substance addiction 307149 0
Condition category
Condition code
Mental Health 306271 306271 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is aimed to evaluate the clinical and cost effectiveness of a Modified Dialectical Behaviour Therapy (DBT) Group Program in treating young people with co-morbid substance abuse and mental health concerns. This modified DBT group program (the intervention) is embedded within a Mission Australia Triple Care Farm (TCF), residential rehabilitation and treatment program for young people aged 16-24 years.

The intervention, the modified DBT group program, is a skills-based therapeutic group program delivered over the course of 12 weeks. The group program is integrating drug and alcohol treatment with Dialectical Behaviour Therapy (DBT), developing emotional regulation, inter-personal effectiveness, mindfulness, distress tolerance, drug refusal and relapse prevention. It is designed to address the complex needs that young people accessing Alcohol and Other Drugs (AOD) services present with, including high levels of: poly substance use, comorbid mental illness, service access including acute hospital services, and risk taking behaviour including suicide and violence.

Over the course of these 12 weeks, staff not only provide treatment for addiction but also seek to address underlying issues and contributing factors to the young person's situation. During their stay, the young person works through a 12 week individually tailored program, addressing addiction and mental health issues. They receive one-on-one counselling with psychologists, develop treatment plans for mental health issues, and participate in group therapy sessions and educational workshops.

The modified DBT group program consists of a group therapy program, accompanied by a facilitator manual, participant workbook, see website www.dbtregulator.com.au.

Intervention code [1] 301280 0
Behaviour
Comparator / control treatment
No treatment - Control group that did not receive the Modified Dialectical Behaviour Therapy (DBT). The control group consisted of young people provided with treatment and care (not DBT) at Triple Care Farm between 2008 and 2009. This existing data-set will be used for comparison.
Control group
Historical

Outcomes
Primary outcome [1] 305270 0
The primary outcome measure is the Brief Symptom Inventory (BSI) (Derogatis, 1975). The BSI total score, most indicative of general psychopathological symptom severity, will be computed as the mean score of all individual items (range 0-4). Lower BSI scores correspond to less symptoms and a more beneficial outcome, and treatment success is defined as a 50% reduction in BSI score on follow-up compared to baseline BSI score.
Timepoint [1] 305270 0
Post- intervention: 3 months from program entry
Secondary outcome [1] 344668 0
Secondary outcomes are severity of dependence and drug use - Severity of Dependence Scale (SDS)
Timepoint [1] 344668 0
Post- intervention: 3 months from program entry

Eligibility
Key inclusion criteria
Triple Care Farm is a youth rehabilitation facility for young people between the ages of 16-24 years, with substance abuse, mental illness, homelessness and family breakdown. TCF specialises in treating young people who also are suffering with mental health issues, however, this is not a requirement of entry. The inclusion/exclusion criteria are outlined below:

The young person must:
1) Be aged between 16 and 24
2) Have problematic drug and alcohol use; problematic drug and alcohol use is daily or near daily use and use of multiple types of drugs
3) Be able to participate in all aspects of the program; participants must be physically, developmentally and mentally capable of participating in all activities
4) Demonstrate commitment to undertake the program, as assessed at interview; TCF is voluntary – participants cannot be forced to attend or participate
5) Must be an Australian resident, currently residing in Australia
Minimum age
16 Years
Maximum age
24 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Not aged between 16 and 24; Participants can’t enter before their 16th birthday and must complete the program before their 25th birthday
2) Not able to participate in all aspects of the program; participants that are not physically, developmentally and mentally capable of participating in all activities

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to describe the demographic and clinical characteristics of the two groups and the outcome variables at the five measurements points. Data will be analysed as intention-to-treat (ITT), with time as a repeated measure, to analyse the short and long-terms effects between and within the control group and the Modified DBT program- group over time. Differences are considered statistically significant at p < 0.05. Missing values will be imputed with regression imputation techniques.

Regression models and survival analyses will be used to understand all aspects of treatment and outcomes over time. Effectiveness of each treatment condition will be evaluated using a Multi-level linear modelling approach (SPSS-21 Linear Mixed Models).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 22149 0
2577 - Knights Hill

Funding & Sponsors
Funding source category [1] 299043 0
Government body
Name [1] 299043 0
NSW Health - Non-Government Organisation (NGO) Evaluation Grants Round 1
Address [1] 299043 0
Locked Mail Bag 961
NORTH SYDNEY
NSW 2059
Country [1] 299043 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Triple Care Farm, Mission Australia
Address
Triple Care Farm – Mission Australia
188 Knights Hill Rd, Knights Hill NSW 2577
Country
Australia
Secondary sponsor category [1] 298277 0
University
Name [1] 298277 0
University of Wollongong
Address [1] 298277 0
Northfields Ave, Wollongong NSW 2522
Country [1] 298277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299977 0
University of Wollongong and Illawarra Shoalhaven LHD Health and Medical HREC
Ethics committee address [1] 299977 0
Research Services Office, University of Wollongong, Northfields Avenue, Wollongong NSW 2522
Ethics committee country [1] 299977 0
Australia
Date submitted for ethics approval [1] 299977 0
06/06/2017
Approval date [1] 299977 0
01/08/2017
Ethics approval number [1] 299977 0
2017/233
Ethics committee name [2] 299978 0
Aboriginal Health & Medical Research Council (AH&MRC) Ethics Committee
Ethics committee address [2] 299978 0
3/66 Wentworth Ave, Surry Hills NSW 2010
Ethics committee country [2] 299978 0
Australia
Date submitted for ethics approval [2] 299978 0
31/08/2017
Approval date [2] 299978 0
30/01/2018
Ethics approval number [2] 299978 0
1319/17

Summary
Brief summary
Dialectical Behaviour Therapy (DBT) has been proven to be an efficacious treatment for borderline personality disorder (BPD) (Linehan, 1993; McMain et al., 2009). However, generalisability of this outcome within adolescents and young adults with co-morbid substance abuse and mental health concerns within a residential care setting in Australia has not been investigated.

The primary aim of this study is to evaluate the clinical effectiveness of a Modified Dialectical Behaviour Therapy (DBT) Group Program embedded within a residential program in treating adolescents and young adults aged 16 to 24 years, experiencing substance misuse over time compared to a control group that did not receive the DBT Group Program. The secondary aim is to identify the factors that predict who is most likely to benefit from such treatment, particularly in terms of improved vocational outcomes (employment and education).
Additionally, the cost-effectiveness of this modified DBT program will be evaluated. Finally, client and therapist satisfaction will also be explored through the study.

Evaluation of the effectiveness of the DBT program in treating young people with co-morbid substance abuse and mental health concerns – one of the most difficult cohorts to treat – is an important first step in improving mental health care for this population. This research will advance the knowledge in the field by providing evidence for the importance of continuously improving service and quality person-centred care, taking into account factors that could contribute to positive treatment outcomes.

This project will be conducted at Triple Care Farm (TCF, Mission Australia in partnership with the University of Wollongong (UOW).

Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82146 0
Prof Brin Grenyer
Address 82146 0
University of Wollongong
Project Air Strategy
Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 82146 0
Australia
Phone 82146 0
+61 2 4221 3474
Fax 82146 0
Email 82146 0
grenyer@uow.edu.au
Contact person for public queries
Name 82147 0
Prof Brin Grenyer
Address 82147 0
University of Wollongong
Project Air Strategy
Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 82147 0
Australia
Phone 82147 0
+61 2 4221 3474
Fax 82147 0
Email 82147 0
grenyer@uow.edu.au
Contact person for scientific queries
Name 82148 0
Prof Brin Grenyer
Address 82148 0
University of Wollongong
Project Air Strategy
Building 22, Room G20A | Northfields Avenue | NSW 2522 | Wollongong | Australia
Country 82148 0
Australia
Phone 82148 0
+61 2 4221 3474
Fax 82148 0
Email 82148 0
grenyer@uow.edu.au

No information has been provided regarding IPD availability
Summary results
No Results