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
ACTRN12621000723886
Ethics application status
Approved
Date submitted
9/04/2021
Date registered
9/06/2021
Date last updated
19/01/2023
Date data sharing statement initially provided
9/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
What does it take to stop hitting home? Voices of family violence
Scientific title
A mixed-method investigation of themes and recommendations for intervention and research by individuals with lived experience of family violence and self-harm
Secondary ID [1] 303858 0
New Zealand Lottery Grants Board - 2021-152813
Universal Trial Number (UTN)
Trial acronym
NZFV study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Family violence 321424 0
Self-harm 321425 0
Suicidal behaviour 321426 0
Condition category
Condition code
Mental Health 319184 319184 0 0
Suicide
Public Health 319185 319185 0 0
Other public health
Mental Health 319186 319186 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study is examining the relationship between exposure to family violence, and later suicidal ideation and behaviour, and engagement in family violence. The investigation involves open-ended qualitative interviews with participants, primarily conducted face-to-face, coupled with an electronic survey which can be completed on the day of the interview, or later on. The interview is expected to take 1-2 hours, and the survey 20-30 minutes.
Intervention code [1] 320214 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327116 0
Responses to survey on relevance of primary outcome measures for future trials assessed through participant responses during survey.
Timepoint [1] 327116 0
At survey completion.
Primary outcome [2] 327117 0
Recruitment rate (i.e. number of eligible individuals within each of 3 categories) who are approached to take part and consent vs decline).
Timepoint [2] 327117 0
From the beginning of recruitment (once full ethics approval is granted), to the point of recruitment closure.
Primary outcome [3] 327118 0
Qualitative descriptions of life experiences related to exposure to family violence, engagement in family violence, and suicidal ideation and behaviour (their own and/or others with whom they are/have been in a family relationship assessed through participant responses during interview. This is a composite primary outcome.
Timepoint [3] 327118 0
At interview
Secondary outcome [1] 393865 0
Survey responses to questions related to confidentiality assessed through participant responses during survey.
Timepoint [1] 393865 0
At survey completion.
Secondary outcome [2] 395335 0
Responses to survey on ease of completion of primary outcome measures for future trials assessed through participant responses during survey.
Timepoint [2] 395335 0
At survey completion.
Secondary outcome [3] 395336 0
Responses to survey on cultural appropriateness of primary outcome measures for future trials assessed through participant responses during survey.
Timepoint [3] 395336 0
At survey completion.
Secondary outcome [4] 395337 0
Survey responses to questions related to safety assessed through participant responses during survey.
Timepoint [4] 395337 0
At survey completion.
Secondary outcome [5] 395338 0
Survey responses to questions related to research engagement assessed through participant responses during survey.
Timepoint [5] 395338 0
At survey completion.

Eligibility
Key inclusion criteria
3 categories (which may overlap):
(1) Up to 12 male adults aged 18 and over who have engaged in family violence as defined by the NZ Family Violence Act 2018* and who also have a history of suicidal behaviour**
(2) Up to 12 adults (male, female and/or gender expansive) aged 18 and over who have experienced family violence inflicted by a male who has a history of suicidal behaviour
(3) Up to 32 young people aged 16-25 who have been exposed to family violence and who also have a history of suicidal behaviour.
Per ethics committee requirement, participants from all categories must be connected with a health or community practitioner.

*Specifically, violence towards a person with whom that individual is, or has been, in a family relationship (e.g. spouse/romantic partner, family member, ordinarily sharing a household, or otherwise having a close personal relationship with the person), where violence means all or any of the following: physical abuse; sexual abuse; psychological abuse that is coercive/controlling and/or causes cumulative harm.
**These include suicide attempts (i.e. life-threatening acts and/or acts that lead to tissue damage, with suicidal intent), suicide threats coupled with high-risk behaviour, and self-injury coupled with suicidal ideation with or without suicidal intent.
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. Lack of connection to a health or community practitioner, and unwillingness to get connected with one as a pre-requisite to taking part in the study.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the interviews and verbal responses to the survey, an inductive approach to data analysis will be used, drawing on grounded theory analytic strategies of comparative analysis (Glaser & Strauss, 2017). In accordance with grounded theory, preliminary exploration will identify patterns, themes and their interrelationships through the use of an open coding process. This will involve the use of fieldnotes, the ongoing and collaborative engagement with participants and the testing of emerging findings with participants and support organisation representatives. Importantly, the process of constant and collaborative comparative analysis provides an opportunity to determine the extent to which patterns were common across participants while simultaneously exploring reasons underlying these patterns. Finally, an emergent theory will be developed by juxtaposing participants’ narratives and the extent to which these complement or contrast existing research and conventional understanding.

For the quantitative aspects of the survey (e.g. ratings of questionnaire acceptability, responses to binary questions), descriptive analyses will compute the mean score for each rating, and the percentage of yes/no/not answered responses for each question. These will also inform emergent theory as part of the process described above, and complement the purely qualitative data gathered from interviews.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
13/11/2021
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/09/2023
Actual
Sample size
Target
56
Accrual to date
24
Final
Recruitment outside Australia
Country [1] 23586 0
New Zealand
State/province [1] 23586 0
Nationwide

Funding & Sponsors
Funding source category [1] 308250 0
University
Name [1] 308250 0
Otago Medical School Dean's Research Fund
Country [1] 308250 0
New Zealand
Funding source category [2] 308301 0
Charities/Societies/Foundations
Name [2] 308301 0
Oakley Mental Health Research Foundation
Country [2] 308301 0
New Zealand
Funding source category [3] 308302 0
Government body
Name [3] 308302 0
Lottery Health Research Fund
Country [3] 308302 0
New Zealand
Primary sponsor type
Individual
Name
Emily Cooney
Address
Otago University Wellington,
23a Mein st
Newtown
Wellington, 6021
Country
New Zealand
Secondary sponsor category [1] 309440 0
University
Name [1] 309440 0
Otago University Wellington
Address [1] 309440 0
Otago University Wellington,
23a Mein st
Newtown
Wellington, 6021
Country [1] 309440 0
New Zealand
Other collaborator category [1] 281717 0
Individual
Name [1] 281717 0
Simon Bennett
Address [1] 281717 0
School of Psychology
Massey University
P.O. Box 756
Wellington 6140
Country [1] 281717 0
New Zealand
Other collaborator category [2] 281718 0
Individual
Name [2] 281718 0
Gabrielle Jenkin
Address [2] 281718 0
Otago University Wellington,
23a Mein st
Newtown
Wellington, 6021
Country [2] 281718 0
New Zealand
Other collaborator category [3] 281719 0
Individual
Name [3] 281719 0
Silke Kuehl
Address [3] 281719 0
Otago University Wellington,
23a Mein st
Newtown
Wellington, 6021
Country [3] 281719 0
New Zealand
Other collaborator category [4] 281720 0
Other Collaborative groups
Name [4] 281720 0
Te Whanau O Te Maungarongo
Address [4] 281720 0
Te Whanau O Te Maungarongo
9 Raroa Road,
Hutt Central,
Lower Hutt 5010
Country [4] 281720 0
New Zealand
Other collaborator category [5] 281721 0
Other Collaborative groups
Name [5] 281721 0
Tauawhi Men's Centre
Address [5] 281721 0
Tauawhi Men's Centre
71 Peel Street,
Gisborne 4010
Country [5] 281721 0
New Zealand
Other collaborator category [6] 281722 0
Individual
Name [6] 281722 0
Michael Roguski
Address [6] 281722 0
Kaitiaki Research
20 Oriental Terrace,
Oriental Bay 6011
Wellington
Country [6] 281722 0
New Zealand
Other collaborator category [7] 281778 0
Other Collaborative groups
Name [7] 281778 0
Manaaki Tairawhiti
Address [7] 281778 0
Nga Wai E Rua Building,
1 Lowe Street,
First floor, Gisborne 4010
New Zealand
Country [7] 281778 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308233 0
NZ Central Health and Disability Ethics Committee
Ethics committee address [1] 308233 0
Ethics committee country [1] 308233 0
New Zealand
Date submitted for ethics approval [1] 308233 0
14/01/2021
Approval date [1] 308233 0
20/04/2021
Ethics approval number [1] 308233 0
21/CEN/84

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

Contacts
Principal investigator
Name 110010 0
Dr Emily Cooney
Address 110010 0
Otago University Wellington,
23a Mein st
Newtown
Wellington 6021
New Zealand
Country 110010 0
New Zealand
Phone 110010 0
+64 4 918 6954
Fax 110010 0
Email 110010 0
[email protected]
Contact person for public queries
Name 110011 0
Emily Cooney
Address 110011 0
Otago University Wellington,
23a Mein st
Newtown
Wellington 6021
New Zealand
Country 110011 0
New Zealand
Phone 110011 0
+64 4 918 6954
Fax 110011 0
Email 110011 0
[email protected]
Contact person for scientific queries
Name 110012 0
Emily Cooney
Address 110012 0
Otago University Wellington,
23a Mein st
Newtown
Wellington
New Zealand 6021
Country 110012 0
New Zealand
Phone 110012 0
+64 4 918 6954
Fax 110012 0
Email 110012 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
We don't have ethical approval to make the full transcripts available to investigators out of New Zealand.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11320Study protocol  [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.