Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001277639
Ethics application status
Not yet submitted
Date submitted
21/11/2014
Date registered
5/12/2014
Date last updated
5/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Dialectical Behaviour Skills Group as a school-based wellbeing and prevention program: A feasibility study
Scientific title
The effectiveness of Dialectical Behaviour Skills Group as a school-based wellbeing and prevention program: A feasibility study
Secondary ID [1] 285717 0
NIl
Universal Trial Number (UTN)
U1111-1164-4251
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 293591 0
Depression 293594 0
Condition category
Condition code
Mental Health 293881 293881 0 0
Depression
Mental Health 293882 293882 0 0
Anxiety
Public Health 293952 293952 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dialectical Behaviour Therapy Skills Group which comprises of modules on: a) Mindfulness; b) Interpersonal Effectiveness; c) Emotion Regulation; and d)Distress Tolerance.

The skills group will be delivered in the form of weekly workshops lead by a face-to-face by a external clinical psychologist facilitator. The workshops will be 1 hour in duration and go for a period of 10 weeks.

The sessions will be audio recorded and verified for treatment fidelity by an independent research, not connected to the trial.
Intervention code [1] 290673 0
Prevention
Intervention code [2] 290674 0
Behaviour
Comparator / control treatment
Classes as usual
Control group
Active

Outcomes
Primary outcome [1] 293663 0
Psychopathology symptoms as measured by the Depression, Stress, and Anxiety Scale - Short Form (DASS-21). The composite score as well as the 3 subscale scores (Depression, Anxiety, and Stress) will be used.
Timepoint [1] 293663 0
Pre, post, 6-month, and 12-month
Secondary outcome [1] 311532 0
Flourishing Scale
Timepoint [1] 311532 0
Pre, post, 6-month, and 12-month
Secondary outcome [2] 311533 0
Strengths and difficulties questionnaire
Timepoint [2] 311533 0
pre, post, 6month, and 12month

Eligibility
Key inclusion criteria
All students in selected school year (either Year 10 or Year 11)
Minimum age
15 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher not associated with the project will randomise participants using a random number generator in Excel. Participants will be randomised according to tutorial groups (block randomisation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher not associated with the project will randomise participants using a random number generator in Excel. Participants will be randomised according to tutorial groups (block randomisation).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The expected sample will comprise of approximately 100 participants. This sized sample was selected as it represents the largest sample manageable to present the workshops to as an entire group. The study is a feasibility study and so the main objective is to evaluate the ease with which this material can be presented to this population and observe some trends on the outcome measures. As such no power analysis was used.

The principle analysis will be a between factors, repeated measures MANOVA statistical analysis. This will be used to determine if self-report mental health changes between the different time points (pre- and post-intervention, 6-month, and 12-month) are significantly different between the control and experimental conditions. Baseline psychopathology will be controlled for to separate the participants who are unwell at the start of treatment from those who are healthy, allowing efficacy of the program to reduce existing symptoms to be established in addition to its ability to prevent the occurrence of future episodes. Prevention of mental health disorders will be assessed using the symptom cut-off of relevant measures. A second set of analysis will use MANOVAs to examine improvements on wellbeing using the Flourishing Scale. A final analysis employing Thematic Analysis will examine the qualitative data to explore reported improvements in functioning and satisfaction with the program.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 290292 0
Charities/Societies/Foundations
Name [1] 290292 0
Black Puppy Foundation
Country [1] 290292 0
Australia
Primary sponsor type
Individual
Name
Mr Rowan Burckhardt
Address
Black Dog Institute
Hospital Rd,
Randwick, NSW, 2031
Australia
Country
Australia
Secondary sponsor category [1] 289003 0
None
Name [1] 289003 0
Address [1] 289003 0
Country [1] 289003 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292000 0
UNSW ethics committee
Ethics committee address [1] 292000 0
University of New South Wales,
High St,
Kensington, NSW, 2052
Ethics committee country [1] 292000 0
Australia
Date submitted for ethics approval [1] 292000 0
21/11/2014
Approval date [1] 292000 0
Ethics approval number [1] 292000 0

Summary
Brief summary
High school students from a Sydney school will be recruited to participate in the study. Students will be randomly allocated to either control or intervention condition. The intervention group will receive 10 hours of the intervention over a school term. The intervention is a Dialectical Behaviour Skills Group, which includes training of skills in 4 domains: Mindfulness, Interpersonal Effectiveness, Emotion Regulation, and Distress Tolerance. A large volume of studies have demonstrated the effectiveness of these skills in improving emotion regulation, interpersonal relationships, and wellbeing. It is expected that this evaluation will demonstrate an improvement of wellbeing and decrease in psychopathology symptoms in the intervention group compared to control participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 52994 0
Mr Rowan Burckhardt
Address 52994 0
Black Dog Institute,
Hospital Rd,
Randwick, NSW, 2031
Country 52994 0
Australia
Phone 52994 0
+61 2 9382 8520
Fax 52994 0
Email 52994 0
[email protected]
Contact person for public queries
Name 52995 0
Mr Rowan Burckhardt
Address 52995 0
Black Dog Institute,
Hospital Rd,
Randwick, NSW, 2031
Country 52995 0
Australia
Phone 52995 0
+61293829508
Fax 52995 0
Email 52995 0
[email protected]
Contact person for scientific queries
Name 52996 0
Mr Rowan Burckhardt
Address 52996 0
Black Dog Institute,
Hospital Rd,
Randwick, NSW, 2031
Country 52996 0
Australia
Phone 52996 0
+61293829508
Fax 52996 0
Email 52996 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.