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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]

None.

Universal Trial Number (UTN)

U1111-1275-2168

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Violent behaviour

Suicidal ideation and behaviour

Emotion dysregulation

Substance use

PTSD

Condition category

Condition code

Mental Health

Suicide

Public Health

Health promotion/education

Injuries and Accidents

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]

Not applicable

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Post-session ratings of skill helpfulness, relevance, and cultural acceptability, using 11-point Likert scales. This is a composite primary outcome.

Timepoint [1]

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]

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]

At the conclusion of the 6 months of skills groups

Primary outcome [3]

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]

At the conclusion of the 6 months of skills groups.

Secondary outcome [1]

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]

From the start date of recruitment to the point of recruiting the last group member

Secondary outcome [2]

Responses from an end-of-skills-group survey assessing recommendations regarding the design of future research, designed specifically for this study.

Timepoint [2]

At the conclusion of the 6 months of skills groups

Secondary outcome [3]

Dropout rate as assessed by an audit of study records.

Timepoint [3]

At the conclusion of 6 months of skills group sessions

Secondary outcome [4]

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]

Across the 6 months of skills groups

Secondary outcome [5]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

Level 3/110 Stanley Street, Grafton, Auckland 1010, New Zealand

Country [1]

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]

University

Name [1]

University of Otago, Wellington

Address [1]

23A Mein Street, Newtown, Wellington 6242

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Puti Snowden

Address [1]

Te Whanau O Te Maungarongo, 9 Raroa Road, Hutt Central, Lower Hutt 5010

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

John Snowden

Address [2]

Te Whanau O Te Maungarongo, 9 Raroa Road, Hutt Central, Lower Hutt 5010

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee (Health)

Ethics committee address [1]

University of Otago Human Ethics Committee (Health)
Academic Committees Office
1st Floor, 
Scott/Shand House, 
90 St David's Street, 
Dunedin

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

17/01/2022

Approval date [1]

31/01/2022

Ethics approval number [1]

H22/012

Summary

Brief summary

We (the PI and Te Whanau O Te Maugarongo) want to offer a 6 month DBT skills group to young people experiencing suicidal urges who have also been exposed to family violence. Te Whanau O Te Maugarongo (henceforth referred to as Maungarongo) is a non-governmental community organisation in Lower Hutt, which offers non-violence, victim survivor, whanau support and whanau resilience services to men, women, youth, children, couples, and whanau/families in the Lower Hutt, Wairarapa and Chatham Islands regions. It aims to develop and enhance the wellbeing of Maori men, women, youth and children. We want to assess whether DBT skills have anything to contribute to the wellbeing of young people attending Maungarongo who have experienced family violence, and suicidal urges.  We also want to find out from whanau accessing this intervention how to develop research protocols for these problems that foster engagement, collaboration and shared ownership of the discovery of what works.

-	Whether participants find DBT skills training acceptable
-	The outcomes they think are relevant to assessing the impact of this initiative
-	Their recommendations for adapting DBT skills training to meet the needs of whanau Maori experiencing these problems
-	Their recommendations for intervention research design

Through embarking on an exploration of these questions, in collaboration with young people attending services at Maungarongo, we will grow the relationships and foundation necessary to develop and evaluate DBT skills training for suicidal whanau attending Maungarongo who have 
-	used violence within their homes
-	survived violence within their homes

We hope that this research activation initiative will help us form the partnerships, research capacity, and processes necessary to undertake research in the future that will examine the feasibility of applying this therapeutic approach to the specific problems encountered by whanau experiencing family violence.

Trial website

Trial related presentations / publications

Public notes

This is considered to be an observational study as this 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 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.

Regarding the inclusion criteria:
 If Te Whanau O Te Maungarongo staff believe that the individual is an inappropriate candidate for the group due to lack of proficiency in spoken English, learning difficulties, or psychosis, then this will be an exclusion criterion. In previous studies we have used intellectual impairment, and active psychosis as exclusion criteria, and measured these with the SCID-5 for psychosis and intellectual disability via the revised version of the Peabody Picture Vocabulary Test.  However we have concerns about the validity of these measures in this context, as well as how the administration of these would be experienced by participants.  We are deliberately keeping the age range of the group flexible to be open to the possibility that family groups from the same home may want to attend together, and to allow the inclusion of younger siblings that are of an age to consent (rather than assent).  However if this is not the case, we intend to restrict groups to  either individuals aged 16-25 years, or 18 years and above, depending on the ages of individuals who want to take part. Also, the study is not restricted to males and females above; nonbinary individuals are welcome to take part.

Contacts

Principal investigator

Name

Dr Emily Cooney

Address

OUW, 23a Mein st, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64274850899

Fax

emily.cooney@otago.ac.nz

Contact person for public queries

Name

Emily Cooney

Address

OUW, 23a Mein st, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64274850899

Fax

emily.cooney@otago.ac.nz

Contact person for scientific queries

Name

Emily Cooney

Address

OUW, 23a Mein st, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64274850899

Fax

emily.cooney@otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Email
15267	Study protocol	emily.cooney@otago.ac.nz
15268	Informed consent form	emily.cooney@otago.ac.nz
15269	Clinical study report	emily.cooney@otago.ac.nz
15270	Ethical approval	emily.cooney@otago.ac.nz

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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