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Trial registered on ANZCTR


Registration number
ACTRN12624001292561
Ethics application status
Approved
Date submitted
9/08/2024
Date registered
24/10/2024
Date last updated
24/10/2024
Date data sharing statement initially provided
24/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dads Tuning in to Kids: Real-world evaluation
Scientific title
Dads Tuning in to Kids: A dissemination trial evaluating the impact of a parenting program on emotion socialisation with fathers of 3 to 12 year old children
Secondary ID [1] 312727 0
None
Universal Trial Number (UTN)
Trial acronym
DadsTIK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Father's mental health 334746 0
Father's parenting difficulties 334747 0
Child behaviour difficulties 334748 0
Condition category
Condition code
Mental Health 331307 331307 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a dissemination trial where facilitators from 40 services will deliver the Dads Tuning in to Kids (Dads TIK) parenting program. All participants receive the intervention: there is no control condition.

Facilitators (across disciplines) from a range of services are trained and supervised to delivery the 7-session group program to fathers of 3 to 12 year old children attending their services. Training involved 13.5 hours of online Tuning in to Kids training over Zoom, followed by 4.5 hours of Dads TIK training provided 1-2 months prior to delivery of the first Dads TIK groups. Facilitators then attended a 1 hour adaptation session and 3 x 1 hour supervision sessions during the period of program delivery. Training, adaptation and supervision is provided by experienced TIK trainers.

The program is delivered by two facilitators in weekly, 2-hour group sessions, either face to face or online. Program adaptations are able to be made to ensure Dads TIK can effectively reach fathers who may not attend a parenting service.

Facilitators use a manualised delivery and fathers are given handout materials, either the standard package (Wilson et al., 2015) or a simplified English (created specifically for this study for fathers with low literacy) or translated into the relevant language. The program has skills for responding using emotion coaching with children as well as skills for fathers to understand and regulate their own emotions. Fidelity checklists are completed after each session by facilitators.

The program was delivered either face-t0-face or online using either the 7 x 2 hour

Wilson, K.R., Havighurst, S.S. & Harley, A.E. (2015). Dads Tuning in to Kids: Program Manual. The University of Melbourne.
Intervention code [1] 329248 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339071 0
Father emotion socialisation
Timepoint [1] 339071 0
Baseline and immediately post-intervention follow-up
Primary outcome [2] 339072 0
Father empathy
Timepoint [2] 339072 0
Baseline and immediately post-intervention follow-up
Primary outcome [3] 339073 0
Father stress
Timepoint [3] 339073 0
Baseline and immediately post-intervention follow-up
Secondary outcome [1] 438475 0
Child behaviour
Timepoint [1] 438475 0
Baseline and immediately post-intervention follow-up
Secondary outcome [2] 438476 0
Father's Personal Wellbeing
Timepoint [2] 438476 0
Baseline and immediately post-intervention follow-up

Eligibility
Key inclusion criteria
Participant inclusion was being a father of a 3-12 year old child. However, the services that delivered the intervention were often targeting hard to reach fathers: culturally and linguistically diverse settings, court ordered/justice clients, inmates in prisons, Indigenous community services, fly-in-fly out fathers (mining areas) etc.
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Prevention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive statistics. Paired samples T-tests. Linear mixed models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2023
Date of last participant enrolment
Anticipated
Actual
1/05/2024
Date of last data collection
Anticipated
Actual
28/06/2024
Sample size
Target
800
Accrual to date
Final
358
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 317154 0
Charities/Societies/Foundations
Name [1] 317154 0
Movember
Country [1] 317154 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319423 0
None
Name [1] 319423 0
Address [1] 319423 0
Country [1] 319423 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315905 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 315905 0
Ethics committee country [1] 315905 0
Australia
Date submitted for ethics approval [1] 315905 0
18/12/2022
Approval date [1] 315905 0
17/02/2023
Ethics approval number [1] 315905 0
2023-25163-36986-5

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

Contacts
Principal investigator
Name 136166 0
Prof Sophie Havighurst
Address 136166 0
Mindful: Centre for Training and Research in Developmental Health, Department of Psychiatry, The University of Melbourne, Building C, 50 Flemington Street, Travancore 3032, Melbourne, Victoria, Australia
Country 136166 0
Australia
Phone 136166 0
+61 3 8344 4458
Fax 136166 0
Email 136166 0
sophie.h@unimelb.edu.au
Contact person for public queries
Name 136167 0
Sophie Havighurst
Address 136167 0
Mindful: Centre for Training and Research in Developmental Health, Department of Psychiatry, The University of Melbourne, Building C, 50 Flemington Street, Travancore 3032, Melbourne, Victoria, Australia
Country 136167 0
Australia
Phone 136167 0
+61 3 8344 4458
Fax 136167 0
Email 136167 0
sophie.h@unimelb.edu.au
Contact person for scientific queries
Name 136168 0
Sophie Havighurst
Address 136168 0
Mindful: Centre for Training and Research in Developmental Health, Department of Psychiatry, The University of Melbourne, Building C, 50 Flemington Street, Travancore 3032, Melbourne, Victoria, Australia
Country 136168 0
Australia
Phone 136168 0
+61 3 8344 4458
Fax 136168 0
Email 136168 0
sophie.h@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Small samples from individual groups. Trust was an issue anticipated by many of the participants and so sharing of data was expected to reduce study participation.


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.