Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000509763
Ethics application status
Approved
Date submitted
20/12/2021
Date registered
30/03/2022
Date last updated
12/04/2023
Date data sharing statement initially provided
30/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Kids First Caring Dads and ODysseY House (KODY), an all-of-family response to co-occurring substance misuse and domestic violence: trialling an enhanced intervention with men and their family members to investigate its impact on safety and wellbeing for women and children
Scientific title
Trial of an all-of-family response to co-occurring substance misuse and domestic violence: an enhanced intervention with men and their family members to investigate its impact on safety and wellbeing for women and children
Secondary ID [1] 305909 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
KODY - [K] ids First and [OD] ysse [Y] House Victoria
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Substance Misuse 324482 0
Domestic Violence 324483 0
Child Welfare 324484 0
Parenting 324485 0
Condition category
Condition code
Public Health 321966 321966 0 0
Other public health
Mental Health 321967 321967 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial intervention (KODY) intervenes with men who use both violence and alcohol and other drugs, through an enhanced "Caring Dads" intervention, aiming to improve the safety and well-being of the men’s children and their (ex)partners. "Caring Dads" is a 17 session, empirically-based and manualised group parenting intervention for fathers who use violence, with a focus on engaging men to examine their fathering, increasing child centred fathering, including respect and support of children’s mothers, and changing patterns of harmful fathering. [Scott, K. L., Kelly, T., Crooks, C. & Francis, K. (2018). Caring Dads: Helping Fathers Value their Children, 2nd Edition. London, ON, Canada.]
Allocation of participants to the trial intervention will be based on eligibility, particularly that fathers must be receiving support through Odyssey House Victoria clinicians. All eligible participants will be allocated to the trial program, based on service availability and participant choice.

Components of KODY include:
Group work - “Caring Dads standard” program with specialist AOD facilitation of group sessions and AOD-focussed content incorporated into the “Caring Dads” curriculum. For example, discussions of each curriculum topic will include, consideration of violent behaviour (“Caring Dads standard” ) and also men’s use of AOD and its interaction with violent behaviour and impact on family. Extra sessions will not be added. The intervention uses a combination of motivational interviewing, psychoeducation, cognitive behavioural therapy and group-based processing to focus on engaging men to examine their fathering, increasing child centred fathering, including respect and support of children’s mothers, and changing patterns of harmful fathering. The group is conducted in weekly 2-hour sessions over 3-4 months, with a maximum of 12 participants in each group. Two ‘booster’ (group) sessions are also offered, at 4 and 8 weeks after the group program finishes – to review and support participants’ ongoing change progress and application of program content.

Case Coordination - Collaborative case coordination for fathers by, consisting of regular weekly meetings of the Caring Dads facilitators with other KODY DV and AOD practitioners. In addition, all-of-family case management by a family support program (Kids in Focus) whose staff specialise in DV and AOD, will be integrated with Caring Dads case coordination.

Services for mothers and children - mothers of children with whom fathers have contact are provided support and safety planning through a Child and Family Wellbeing Practitioner. Contact is offered at least four times, and is agreed between the practitioner and each mother. Participants in the ‘Caring Dads standard’ program do not have access to the Kids in Focus program.

Kids in Focus (KIF) for mothers, children and fathers - a specialist child, parenting and family support service for families where a parent has an alcohol and/or other drug problem. Families are visited in their home at least weekly, typically for an hour. However, depending on needs and goals of each family, visits may be more frequent and longer. As the individual needs of each family and its members differ, service design is not standardised across families but is tailored to each individual, drawing on the following components, as appropriate for each family.
- The Parents under Pressure (PUP) program consisting of 12 psycho-educational modules covering parenting, child behaviour and parental emotion regulation within a case management model, and is tailored to each family and delivered in their own home.
- My Kids and me - a manualised psycho-educational seven session course (weekly, 2 hours, maximum group size 10 participants) for parents whose children have been removed from their care due to parental substance misuse or dependence, and who are involved with the Family Drug Treatment Court, a program within the Family Division of the Children’s Court of Victoria. Rather than practical parenting help, this program aims to enable reflection and ‘moments of change’.
- Information and referral
- Advocacy and support in relation to other services such as child protection
- Domestic and Family violence assessment and intervention
- Individual Counselling
- Therapeutic family camps (12-17 families)

Monitoring adherence and participation: Session attendance sheets will be kept for participants in all group programs. In addition, participation charts will be developed for fathers, mothers and children, to record what services they have received from the Child and Family Wellbeing Practitioner and from Kids in Focus, including frequency of professional contact.
Intervention code [1] 322451 0
Behaviour
Comparator / control treatment
The “Caring Dads standard” program (the control treatment) consists of the following components.
Group work - "Caring Dads standard": 16 group and 1 individual session (at Session 10), as well as three individual assessment/engagement sessions before the group program commences. As with the KODY version, the intervention uses a combination of motivational interviewing, psychoeducation, cognitive behavioural therapy and group-based processing to focus on engaging men to examine their fathering, increasing child centred fathering, including respect and support of children’s mothers, and changing patterns of harmful fathering. The group is conducted in weekly 2-hour sessions over 3-4 months, with a maximum of 12 participants in each group. Two ‘booster’ (group) sessions are also offered, at 4 and 8 weeks after the group program finishes – to review and support participants’ ongoing change progress and application of program content.
Case Coordination - case coordination between group intervention and mother contact practitioners.
Services for mothers and children - mothers of children with whom fathers have contact are provided support and safety planning through a Child and Family Wellbeing Practitioner. Participants in the control group will receive only this level of support and will not have access to the Kids in Focus program.
Control group
Active

Outcomes
Primary outcome [1] 329903 0
Primary Outcome 1. Safety of women, assessed by the Composite Abuse Scale (Mothers only).
Timepoint [1] 329903 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Primary outcome [2] 329904 0
Primary Outcome 2. Safety of children, measured by the Emotional Dysregulation Scale (fathers and mothers)
Timepoint [2] 329904 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Primary outcome [3] 330821 0
Primary Outcome 3. Wellbeing of children, measured by the Brief Infant-Toddler Social and Emotional Assessment (under 3 years) or the Strengths and Difficulties Questionnaire (for ages 3+) (mothers only)
Timepoint [3] 330821 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [1] 404217 0
Primary Outcome 2. safety of children, measured by Interpersonal Mindfulness in Parenting Scale (fathers only)
Timepoint [1] 404217 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [2] 404218 0
Secondary Outcome 1. - Fathers' use of domestic violence, measured by the Anger Management Scale (fathers only)
Timepoint [2] 404218 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [3] 407706 0
Secondary Outcome 2. Fathers' use of domestic violence, measured by the Brief Irritability Test (fathers only)
Timepoint [3] 407706 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [4] 407708 0
Secondary Outcome 3. Fathers’ level of alcohol use, measured by the Alcohol Use Disorders Identification Test (fathers only)
Timepoint [4] 407708 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [5] 407709 0
Secondary Outcome 4. Fathers’ level of drug use, measured by the Drub Use Disorders Identification Test (fathers only)
Timepoint [5] 407709 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [6] 407713 0
Secondary Outcome 5. Fathers’ use of respect in communication, measured by Mirabal scale 1(mothers only)
Timepoint [6] 407713 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [7] 407714 0
Secondary Outcome 6. Fathers’ fathering practice, measured by Mirabal scale 2 (mothers only)
Timepoint [7] 407714 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program
Secondary outcome [8] 407716 0
Secondary Outcome 7. Fathers’ awareness of self and others, measured by Mirabal scale 3 (mothers only)
Timepoint [8] 407716 0
T1 - baseline
T2 - within 7 days of the end of the "Caring Dads" group program
T3 - 3 months after the end of the "Caring Dads" group program

Eligibility
Key inclusion criteria
1. Fathers who use domestic violence an also use alcohol or other drugs, who undertake 'Caring Dads Standard' or KODY Caring Dads.

2. Fathers must have contact with at least one child.

3. Fathers must be able to understand and speak English.

4. Fathers must have capacity to maintain participation and attend group work regularly, bearing in mind their substance use status.

5. Partners or ex-partners of these fathers are also eligible to participate
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with communication difficulties (cognitive or sensory, language barrier); and participants who do not consent to participate in the study. Participants will be assessed for suitability on a case by case basis as appropriate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
We have made some assumptions to determine the sample size based on previous studies. Assuming a medium effect size (based on Cohen’s d), a power of .80 and a two-tailed test across independent groups, this study will need to involve reports from 128 mothers, 64 in each of the KODY and comparison groups. Reported participation rates for evaluations of Caring Dads programs range from 62% (Diemer et al., 2020) to 97% (McConnell et al., 2016) . Assuming a partner contact success rate of 75% based on the benefits of the Kids in Focus program for women and children, this study will need to enrol 170 families across groups.

Intent to treat analyses will be used so that all service users are included in the primary analysis, allowing for variations in levels of participation in KODY and including those who drop out prematurely. Assuming differences between groups, supplementary analyses will examine the extent to which intervention effects vary according to whether families received a higher or lower ‘dose’ of expanded service. Each component of the study will be analysed separately in the first instance, then brought together to triangulate data collection and analysis, before a final synthesis.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
18/04/2022
Actual
Date of last participant enrolment
Anticipated
11/12/2023
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
170
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310259 0
Government body
Name [1] 310259 0
Australian Research Council
Country [1] 310259 0
Australia
Funding source category [2] 310420 0
University
Name [2] 310420 0
The University of Western Ontario (Western Univ.)
Country [2] 310420 0
Canada
Funding source category [3] 310421 0
Charities/Societies/Foundations
Name [3] 310421 0
Kids First Australia
Country [3] 310421 0
Australia
Funding source category [4] 310422 0
Charities/Societies/Foundations
Name [4] 310422 0
Odyssey House Victoria
Country [4] 310422 0
Australia
Funding source category [5] 310423 0
Government body
Name [5] 310423 0
Department of Families, Fairness and Housing
Country [5] 310423 0
Australia
Primary sponsor type
University
Name
Melbourne School of Health Sciences, Department of Social Work
Address
University of Melbourne
161 Barry St,
Carlton, Vic, 3053
Country
Australia
Secondary sponsor category [1] 312388 0
None
Name [1] 312388 0
Address [1] 312388 0
Country [1] 312388 0
Other collaborator category [1] 282106 0
Individual
Name [1] 282106 0
Professor Cathy Humphreys (Chief Investigator)
Address [1] 282106 0
Melbourne School of Health Sciences,
University of Melbourne
161 Barry St,
Carlton, Vic, 3053
Country [1] 282106 0
Australia
Other collaborator category [2] 282107 0
Individual
Name [2] 282107 0
Dr Margaret Kertesz (Chief Investigator) Senior Research Fellow
Address [2] 282107 0
Melbourne School of Health Sciences,
University of Melbourne
161 Barry St,
Carlton, Vic, 3053
Country [2] 282107 0
Australia
Other collaborator category [3] 282108 0
Individual
Name [3] 282108 0
Dr Anne-Marie Laslett (Chief Investigator) Senior Research Fellow
Address [3] 282108 0
La Trobe University,
Centre for Alcohol Policy Research,
Plenty Rd & Kingsbury Dr,
Bundoora VIC 3086
Country [3] 282108 0
Australia
Other collaborator category [4] 282109 0
Individual
Name [4] 282109 0
Dr Menka Tsantefski (Chief Investigator) Senior Lecturer
Address [4] 282109 0
Griffith University
Parklands Drive
Southport Queensland 4222
Country [4] 282109 0
Australia
Other collaborator category [5] 282110 0
Individual
Name [5] 282110 0
Professor Katreena Scott (Chief Investigator) Director, Centre for Research and Education on Violence Against Women and Children
Address [5] 282110 0
Faculty of Education,
1151 Richmond Street
London, Ontario,
Canada, N6A 3K7
Country [5] 282110 0
Canada
Other collaborator category [6] 282111 0
Individual
Name [6] 282111 0
Sarah Gruner (Partner Investigator) Director, Research & Planning, FSV
Address [6] 282111 0
Director, Research & Planning, FSV
Department of Families, Fairness and Housing,
50 Lonsdale Street, Melbourne, Vic, 3000
Country [6] 282111 0
Australia
Other collaborator category [7] 282112 0
Individual
Name [7] 282112 0
Nicole Artico (Partner Investigator)
Address [7] 282112 0
Kids First Australia
273 Settlement Rd,
Thomastown VIC, 3074
Country [7] 282112 0
Australia
Other collaborator category [8] 282113 0
Individual
Name [8] 282113 0
Dr Stefan Gruenert
Address [8] 282113 0
CEO, Odyssey House Victoria,
660 Bridge Rd,
Richmond VIC 3121
Country [8] 282113 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309931 0
University of Melbourne HREC STEMM 3
Ethics committee address [1] 309931 0
Ethics committee country [1] 309931 0
Australia
Date submitted for ethics approval [1] 309931 0
Approval date [1] 309931 0
21/09/2021
Ethics approval number [1] 309931 0
2021-21142-21907-3

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

Contacts
Principal investigator
Name 115882 0
Prof Cathy Humphreys
Address 115882 0
University of Melbourne,
Melbourne School of Health Sciences,
Level 7, 161 Barry Street,
Carlton, Vic, 3053
Country 115882 0
Australia
Phone 115882 0
+61 437 392 181
Fax 115882 0
Email 115882 0
[email protected]
Contact person for public queries
Name 115883 0
Cathy Humphreys
Address 115883 0
University of Melbourne,
Melbourne School of Health Sciences,
Level 7, 161 Barry Street,
Carlton, Vic, 3053
Country 115883 0
Australia
Phone 115883 0
+61 437 392 181
Fax 115883 0
Email 115883 0
[email protected]
Contact person for scientific queries
Name 115884 0
Margaret Kertesz
Address 115884 0
University of Melbourne,
Melbourne School of Health Sciences,
Level 7, 161 Barry Street,
Carlton, Vic, 3053
Country 115884 0
Australia
Phone 115884 0
+61 407 052 300
Fax 115884 0
Email 115884 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
The ethical approval does not allow for data sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14482Study protocol  [email protected]
14483Informed consent form  [email protected]
14484Ethical approval  [email protected]
14485Clinical study report  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.