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
ACTRN12622000502730
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
29/03/2022
Date last updated
29/03/2022
Date data sharing statement initially provided
29/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Dialectical Behaviour Therapy Skills within an Indigenous Service in Aotearoa New Zealand
Scientific title
Acceptability of Dialectical Behaviour Therapy skills offered within a Kaupapa Maori Family Violence Prevention Service
Secondary ID [1] 306570 0
None.
Universal Trial Number (UTN)
U1111-1275-2168
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Violent behaviour 325469 0
Suicidal ideation and behaviour 325470 0
Emotion dysregulation 325471 0
Substance use 325472 0
PTSD 325473 0
Condition category
Condition code
Mental Health 322854 322854 0 0
Suicide
Public Health 322855 322855 0 0
Health promotion/education
Injuries and Accidents 322856 322856 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The focus of this study is collective and reciprocal learning regarding the relevance, and acceptability of DBT skills for Indigenous participants in New Zealand who have lived experience of family violence and suicidality. Accordingly, DBT skills are offered for evaluation by participants, rather than intervention to them. The plan is to offer six months of weekly 2-hour group sessions of dialectical behaviour therapy (DBT) skills training, however this format and process may change, based on feedback from the service, and from the participants. Typically the first hour of each group session involves mindfulness practice and review of homework assigned the week before. The homework involves practising skills taught the previous week, and completing an optional worksheet reflecting on the skills use. The second hour involves skills instruction, practice, homework assignment, and a closing mindfulness task. The content of these sessions will be an adaptation of the standard curriculum provided by Linehan (2015), modified for this context. The skills fall into the following 5 catagories: mindfulness, emotion regulation, distress tolerance, interpersonal skills and walking the middle path skills. Group sessions include up to 10 participants at a time, and two group facilitators. We will have three facilitators: a pakeha facilitator with expertise in DBT, and two Maori facilitators with expertise in family violence group facilitation, and in working from a te Ao Maori perspective (Maori worldview) with whanau who are traumatised and suicidal. Documentation within each session includes a record of participants who attended, and who completed homework; these will be used to monitor the extent to which the participants have tried out the skills on offer, in order to offer their informed opinion on the skills' relevance and applicability to their lives.
At the conclusion of the skills group, focus group interviews (anticipated to last up to 2 hours) will be held with up to 10 participants within each session in order to obtain feedback regarding the applicability, utility and acceptability of the skills group sessions, and also the research process for participants. These interviews will be conducted by an independent researcher with direct experience of these issues. In addition, participants will be asked to complete post-group questionnaires on the acceptability of DBT skills, and a survey at the conclusion of the skills group sessions, advising on future research design.
NB: This is considered to be an observational study as this most accurately reflects our intention and commitment to structure this research in a way that upholds the mana (dignity and authority) of the participants as partners and consultants with us in this investigation. We do not see them as patients or passive recipients of a treatment. Rather we see them as co-producers of a future treatment. This relates to a key issue that was discussed extensively with the ethics committee, who advised us to be very clear that DBT skills are *not* offered as an intervention in this context. Rather, the participants are serving as a community of lived-experience consultants first and foremost, as opposed to individuals receiving treatment. They are contributing their time and expertise primarily to comment on the acceptability of DBT skills training within Te Ao Maori - within the Maori worldview. This is a core perspective and philosophy underpinning this research.
Intervention code [1] 323005 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330636 0
Post-session ratings of skill helpfulness, relevance, and cultural acceptability, using 11-point Likert scales. This is a composite primary outcome.
Timepoint [1] 330636 0
Weekly during the skills groups phase (i.e. weekly from the point that the first respondent began the skills group, until the point that the last participant completed the skills group)
Primary outcome [2] 330637 0
Responses on a modified version of the Treatment Acceptability Scale at the point of completion of the 6 months of skills group sessions.
Timepoint [2] 330637 0
At the conclusion of the 6 months of skills groups
Primary outcome [3] 330638 0
Responses on a modified version of the Client Satisfaction Questionnaire at the point of completion of the 6 months of skills group sessions.
Timepoint [3] 330638 0
At the conclusion of the 6 months of skills groups.
Secondary outcome [1] 407053 0
Recruitment rate (as an indication of the acceptability of committing to 26 weeks of group sessions), which will be assessed from an audit of study records tracking the time from recruitment of the first participant to the recruitment of the last participant, along with the number of individuals who declined to be involved, and the number of individuals who were deemed ineligible.
Timepoint [1] 407053 0
From the start date of recruitment to the point of recruiting the last group member
Secondary outcome [2] 407054 0
Responses from an end-of-skills-group survey assessing recommendations regarding the design of future research, designed specifically for this study.
Timepoint [2] 407054 0
At the conclusion of the 6 months of skills groups
Secondary outcome [3] 407055 0
Dropout rate as assessed by an audit of study records.
Timepoint [3] 407055 0
At the conclusion of 6 months of skills group sessions
Secondary outcome [4] 407056 0
Homework completion to assess the extent to which participants were motivated to try out the skills on offer and provide an informed view of their acceptability.
Timepoint [4] 407056 0
Across the 6 months of skills groups
Secondary outcome [5] 407188 0
Qualitative feedback on the acceptability and utility of the skills group, and the acceptability of the research design obtained from focus group interviews following group completion.
Timepoint [5] 407188 0
At the conclusion of the 6 months of DBT skills groups.

Eligibility
Key inclusion criteria
We will recruit participants aged 16 years and above who are engaged with Te Whanau o Te Maungarongo, deemed an appropriate referral to the group by Te Whanau staff, and who report having experienced family violence (as defined by the NZ Family Violence Act [2018]), and/or have a lifetime history of either suicide attempt, or significant suicidal ideation and self-injury. All will need to be proficient in spoken English.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of proficiency in spoken English, severe learning difficulties, or psychosis as assessed/identified by te whanau o te maungarongo staff.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Our primary focus is to determine the acceptability of DBT skills, and to gather qualitative data from participants regarding their experience of taking part, and their recommendations for the design of any further research in this area, if their feedback are that DBT skills are helpful. As such we will gather descriptive data relating to individuals' responses on questionnaires and ratings of the utility, cultural acceptability and relevance of skills in their lives. This information will be collected at each session, and at the conclusion of the 6-months of skills groups.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
Date of last participant enrolment
Anticipated
27/06/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 24635 0
New Zealand
State/province [1] 24635 0
Wellington

Funding & Sponsors
Funding source category [1] 310903 0
Government body
Name [1] 310903 0
Health Research Council
Country [1] 310903 0
New Zealand
Primary sponsor type
Individual
Name
Emily Cooney
Address
Department of Psychological Medicine, University of Otago, Wellington, 23A Mein Street, Newtown, Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 312188 0
University
Name [1] 312188 0
University of Otago, Wellington
Address [1] 312188 0
23A Mein Street, Newtown, Wellington 6242
Country [1] 312188 0
New Zealand
Other collaborator category [1] 282182 0
Individual
Name [1] 282182 0
Puti Snowden
Address [1] 282182 0
Te Whanau O Te Maungarongo, 9 Raroa Road, Hutt Central, Lower Hutt 5010
Country [1] 282182 0
New Zealand
Other collaborator category [2] 282183 0
Individual
Name [2] 282183 0
John Snowden
Address [2] 282183 0
Te Whanau O Te Maungarongo, 9 Raroa Road, Hutt Central, Lower Hutt 5010
Country [2] 282183 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310465 0
University of Otago Human Ethics Committee (Health)
Ethics committee address [1] 310465 0
Ethics committee country [1] 310465 0
New Zealand
Date submitted for ethics approval [1] 310465 0
17/01/2022
Approval date [1] 310465 0
31/01/2022
Ethics approval number [1] 310465 0
H22/012

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

Contacts
Principal investigator
Name 117758 0
Dr Emily Cooney
Address 117758 0
OUW, 23a Mein st, Newtown, Wellington, 6242
Country 117758 0
New Zealand
Phone 117758 0
+64274850899
Fax 117758 0
Email 117758 0
[email protected]
Contact person for public queries
Name 117759 0
Emily Cooney
Address 117759 0
OUW, 23a Mein st, Newtown, Wellington, 6242
Country 117759 0
New Zealand
Phone 117759 0
+64274850899
Fax 117759 0
Email 117759 0
[email protected]
Contact person for scientific queries
Name 117760 0
Emily Cooney
Address 117760 0
OUW, 23a Mein st, Newtown, Wellington, 6242
Country 117760 0
New Zealand
Phone 117760 0
+64274850899
Fax 117760 0
Email 117760 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
This research is highly sensitive and the dignity, privacy and ownership of participants' information is of high significance, particularly for Indigenous research in Aotearoa.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15267Study protocol  [email protected]
15268Informed consent form  [email protected]
15269Clinical study report  [email protected]
15270Ethical approval  [email protected]



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.