Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618000866202
Ethics application status
Approved
Date submitted
21/03/2018
Date registered
22/05/2018
Date last updated
25/11/2021
Date data sharing statement initially provided
15/09/2020
Date results provided
25/11/2021
Type of registration
Retrospectively 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 will evaluate the effectiveness of dialectical behaviour therapy (DBT) in treating young people with co-morbid substance abuse and mental health concerns. This DBT group program is embedded within Mission Australia Triple Care Farm (TCF), a residential rehabilitation program for young people aged 16-24 years.

The intervention is a skills-based therapeutic group program delivered over the course of 12 weeks plus residential milieu. The group program integrates drug and alcohol treatment with DBT principles, developing emotional regulation, interpersonal effectiveness, mindfulness, distress tolerance, drug refusal, and relapse prevention. It is designed to address the complex needs of this population including high levels of poly substance use, comorbid mental illness, service access including acute hospital services, and risk taking behaviour including suicide and violence. The DBT component consists of a group therapy program, accompanied by a facilitator manual, participant workbook, and website (www.dbtregulator.com.au).

The residential milieu setting is an 18-bed program which incorporates the general principles of milieu treatment. The treatment model is a 12-week holistic psychosocial rehabilitation
program based on harm minimisation and health promotion. This 12-week program is followed up with community aftercare. The DBT treatment program is embedded within the overall residential milieu. Within the milieu there were general worker-resident activities throughout the day and evening designed to provide therapeutic containment and safety whilst seeking to generalise the use of skills learnt in the DBT program. The wider residential milieu also included individual counselling, principles from psychoeducation, motivational interviewing for substance use and criminality, relapse prevention, strengths-based work, and drug education.
Intervention code [1] 301280 0
Behaviour
Comparator / control treatment
We compared two cohorts from the same 12-week residential substance use disorder (SUD) facility over a ten year period: Cohort A (2008-2009) and Cohort B (2018-2020). Data for Cohort A were routinely collected and archived, being made available for this study in de-identified form following ethical approval. The essential components of the program remained the same with the primary treatment being dialectical behaviour therapy (DBT) plus residential milieu.
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
Sex
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
Completed
Date of first participant enrolment
Anticipated
5/06/2018
Actual
25/01/2018
Date of last participant enrolment
Anticipated
11/02/2020
Actual
25/10/2019
Date of last data collection
Anticipated
20/04/2020
Actual
26/03/2020
Sample size
Target
100
Accrual to date
Final
100
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
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
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
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
Trial website
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
[email protected]
Contact person for public queries
Name 82147 0
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
[email protected]
Contact person for scientific queries
Name 82148 0
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
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseNow and then: a ten-year comparison of young people in residential substance use disorder treatment receiving group dialectical behaviour therapy.2021https://dx.doi.org/10.1186/s12888-021-03372-2
N.B. These documents automatically identified may not have been verified by the study sponsor.