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Trial registered on ANZCTR


Registration number
ACTRN12617000529347
Ethics application status
Approved
Date submitted
27/02/2017
Date registered
11/04/2017
Date last updated
14/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial – the efficacy of dialectical behaviour therapy in young adult prisoners who engage in self-harm
Scientific title
Will prisoners who self-harm reduce their frequency of self-harming after going through the Dialectical Behaviour Therapy intervention?
Secondary ID [1] 291284 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
self-harm 302235 0
borderline personality disorder 302236 0
well-being 302237 0
Condition category
Condition code
Mental Health 301832 301832 0 0
Psychosis and personality disorders
Mental Health 301833 301833 0 0
Suicide
Mental Health 301834 301834 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for young prisoners who self-harm will be the modified dialectical behaviour therapy by Mission Australia’s Triple Care Farm. The group intervention is a 12-week, biweekly group-skills session conducted by two clinical psychologists who are DBT-trained. The modules included will be on mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. 1. Sessions will be in a group therapy format with up to 10 participants per group (Triple Care Farm, 2015). DBT is a structured, skills-based program which will teach participants skills such as mindfulness (i.e. to encourage teaching in the 'here and now' and focus on the present), distress tolerance (i.e. coping skills whenever participants are in a crisis), interpersonal effectiveness (i.e. how to behave in relationships and to maintain respect at the same time) and emotion regulation (i.e. how to identify emotions and manage emotions that are unhelpful or unjustified). Besides teaching skills, participants will also be given a treatment workbook where they can fill in their own notes during sessions.

2. Duration of sessions will be 2-hours

3. Strategies to monitor adherence: Register of attendance at the beginning of each session and a diary-card, where participants will need to tick which skill they used outside therapy times and any reasons why some skills are difficult than others and this will be reviewed at the beginning of every session

4. Biweekly means two sessions a week.
Intervention code [1] 297299 0
Early detection / Screening
Intervention code [2] 297300 0
Treatment: Other
Intervention code [3] 297303 0
Behaviour
Comparator / control treatment
Treatment as Usual: Participants in this group will receive leaflets on self-harm and alternative coping strategies and will be required to meet with the prison doctor for further monitoring. No other therapy will be provided to this group of participants throughout the 12-week period.
Control group
Active

Outcomes
Primary outcome [1] 301255 0
Self-harm behaviours assessed using the Inventory of Statements about Self-Injury (ISAS)
Timepoint [1] 301255 0
Follow-up at Week 16 and 20 post-intervention here means:
3 weeks of screening, plus 12 weeks of intervention.
Week 16 is the week immediately after intervention just ended (follow-up 1) and week 20 is 4 weeks after the intervention (follow-up 2).
Primary outcome [2] 301256 0
Borderline Personality Disorder symptoms as assessed by the Structured Clinical Interview for Borderline Personality Disorder (SCID-BPD)
Timepoint [2] 301256 0
Follow-up at Week 16 and 20 post-intervention here means:
3 weeks of screening, plus 12 weeks of intervention.
Week 16 is the week immediately after intervention just ended (follow-up 1) and week 20 is 4 weeks after the intervention (follow-up 2).
Secondary outcome [1] 332112 0
General well-being (as observed from the Well-being Survey)
Timepoint [1] 332112 0
Follow-up at Week 16 and 20 post-intervention here means:
3 weeks of screening, plus 12 weeks of intervention.
Week 16 is the week immediately after intervention just ended (follow-up 1) and week 20 is 4 weeks after the intervention (follow-up 2).
Secondary outcome [2] 332113 0
Emotion regulation (as observed from the Difficulties in Emotion Regulation, DERS questionnaire)
Timepoint [2] 332113 0
Follow-up at Week 16 and 20 post-intervention here means:
3 weeks of screening, plus 12 weeks of intervention.
Week 16 is the week immediately after intervention just ended (follow-up 1) and week 20 is 4 weeks after the intervention (follow-up 2).

Eligibility
Key inclusion criteria
- Malaysian nationality
- Young adult prisoner aged between 14 and 21 years of age who self-harm
- Males and Females
- Does not necessarily need to know how to read or write, but must be able to understand English or Malay
- Convicted prisoners only
- Remaining length of sentence should be at least 6 months
Minimum age
14 Years
Maximum age
21 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The participant is Non-Malaysian
The participant is only able to comprehend minimum English or Malay language, and is only able to speak in his mother tongue (i.e. Chinese, Tamil or others)
The participant is over 21 years of age
The participant has significant mental health, physical or drug and alcohol concerns that may get in the way of their involvement or threaten the safety of other participants,
The participant has less than 6 months left of his sentence

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Balanced and blocked randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using the sample size calculation method via the G*Power program, in order to produce a medium-to-large effect size with the power of approximately 80% for an independent t-test (to see the differences between two groups), one group should have 64 participants. Consequently, two groups would yield 128 participants. However, this number would just be estimates as determining a sample size for a randomised controlled trial is highly unpredictable (i.e. many variables would affect the final sample size).

Similar randomised controlled trials such as cognitive behaviour therapy intervention for self-harm (Slee et al., 2008); DBT for women with borderline personality disorder (Verheul et al., 2003); DBT with suicidal and self-harming adolescents (Tørmoen et al., 2014); DBT for adolescents with repeated suicidal and self-harm behaviour (Mehlum et al., 2016) among other studies included between 27 to 90 participants in their RCTs.

Therefore, 128 participants in our study would be ideal and might just be more than enough.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/05/2017
Actual
26/04/2017
Date of last participant enrolment
Anticipated
20/12/2017
Actual
27/07/2017
Date of last data collection
Anticipated
20/02/2019
Actual
14/12/2017
Sample size
Target
128
Accrual to date
Final
97
Recruitment outside Australia
Country [1] 8694 0
Malaysia
State/province [1] 8694 0
Malacca

Funding & Sponsors
Funding source category [1] 295748 0
Other Collaborative groups
Name [1] 295748 0
Project Air Strategy for Personality Disorders
Country [1] 295748 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Project Air Strategy for Personality Disorders
Address
Project Air Strategy for Personality Disorder, Illawarra Health and Medical Research Institute, School of Psychology, University of Wollongong, NSW, Australia, 2500
Country
Australia
Secondary sponsor category [1] 294592 0
None
Name [1] 294592 0
Nil
Address [1] 294592 0
Nil
Country [1] 294592 0
Other collaborator category [1] 279452 0
Individual
Name [1] 279452 0
Associate Professor Dr. Muhammad Muhsin Ahmad Zahari
Address [1] 279452 0
Department of Psychological Medicine, Faculty of Medicine, University Malaya, 59100 Kuala Lumpur
Country [1] 279452 0
Malaysia
Other collaborator category [2] 280297 0
Individual
Name [2] 280297 0
Kate Lewis
Address [2] 280297 0
Project AIr Strategy, Northfields Clinic, Building 22.20A, Northfields Avenue, University of Wollongong, NSW 2522
Country [2] 280297 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297048 0
University of Wollongong Human Research Ethics Committee
Ethics committee address [1] 297048 0
Ethics committee country [1] 297048 0
Malaysia
Date submitted for ethics approval [1] 297048 0
05/07/2016
Approval date [1] 297048 0
27/09/2016
Ethics approval number [1] 297048 0
HE16/273
Ethics committee name [2] 297049 0
Medical Ethics Committee, University Malaya Medical Center
Ethics committee address [2] 297049 0
Ethics committee country [2] 297049 0
Malaysia
Date submitted for ethics approval [2] 297049 0
Approval date [2] 297049 0
21/09/2016
Ethics approval number [2] 297049 0
20166-2609

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1539 1539 0 0
/AnzctrAttachments/372437-UOW 16-273 Approval 131016.pdf (Ethics approval)
Attachments [2] 1540 1540 0 0
/AnzctrAttachments/372437-Arina Main - PIS and CF V3.docx (Participant information/consent)

Contacts
Principal investigator
Name 72806 0
Prof Brin Grenyer
Address 72806 0
Building 41
School of Psychology
Faculty of Social Sciences
University of Wollongong
Northfields Avenue
WOLLONGONG NSW 2522
AUSTRALIA
Country 72806 0
Australia
Phone 72806 0
+61 2 4221 3474
Fax 72806 0
+61 2 4221 4163
Email 72806 0
grenyer@uow.edu.au
Contact person for public queries
Name 72807 0
Brin Grenyer
Address 72807 0
Building 41
School of Psychology
Faculty of Social Sciences
University of Wollongong
Northfields Avenue
WOLLONGONG NSW 2522
AUSTRALIA
Country 72807 0
Australia
Phone 72807 0
+61 2 4221 3474
Fax 72807 0
+61 2 4221 4163
Email 72807 0
grenyer@uow.edu.au
Contact person for scientific queries
Name 72808 0
Brin Grenyer
Address 72808 0
Building 41
School of Psychology
Faculty of Social Sciences
University of Wollongong
Northfields Avenue
WOLLONGONG NSW 2522
AUSTRALIA
Country 72808 0
Australia
Phone 72808 0
+61 2 4221 3474
Fax 72808 0
+61 2 4221 4163
Email 72808 0
grenyer@uow.edu.au

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.