Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001223426
Ethics application status
Approved
Date submitted
4/08/2016
Date registered
5/09/2016
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Like Father Like Son: Evaluation of a National Online Parenting Program
Scientific title
Like Father Like Son: Evaluation of a National Online Parenting Program for the reduction of child behavioural problems.
Secondary ID [1] 289529 0
Nil known
Universal Trial Number (UTN)
U1111-1184-6167
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child emotional/behavioural adjustment 299236 0
Condition category
Condition code
Mental Health 299246 299246 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
***Brief name***
ParentWorks


***Intervention development***
This program is based on the Integrated Family Intervention for Child Conduct Problems developed by Professor Mark Dadds and Associate Professor David Hawes (Dadds & Hawes, 2005), and examined in previous research studies (e.g., Hawes & Dadds, 2005). The program has been adapted for an online, self-directed delivery format (through a dedicated website: www.parentworks.org.au) and designed to appeal particularly to fathers (a group that has in the past been difficult to engage in parenting programs). In addition, although the program was originally designed for parents of children with conduct problems, it has been modified for a broader community sample of parents who may have more general concerns about parenting and child behaviour.


***Intervention summary***
There are 5 core modules, 3 optional modules, supplementary information sheets, practice exercises and typed summaries of module content. The modules are presented as videos and contain a male clinical psychologist presenting the material (speaking to camera or as a voiceover); role plays of parents and/or psychologists demonstrating main skills/strategies (with or without voice over); bullet points during the video that summarise the main points; in session exercises/worksheets (approximately 3 per module).


***Detailed intervention description***
Module 1: Getting Started and Setting Up for Success
- Discussion about how the program works
- Causes of child behaviour
- The important role that fathers play in their children’s upbringing
- Barriers to completing the program and how to overcome these
- Setting goals for the program

Module 2: Encouraging Positive Behaviour
- The importance of when and how parents give children attention
- The importance of parents spending quality time with children
- Parents will learn the different strategies to reward children for positive behaviour, including descriptive praise, tangible rewards, physical affection and spending quality time with them

Module 3: Responding to Misbehaviour
- Information will be presented on the following strategies: Setting family rules, giving instructions, using time out
- Trouble-shooting tips for using time-out will be presented

Module 4: Managing Challenging Situations and Sibling Conflict
- The psychologist will begin by explaining what high risk situations are (e.g., car rides, morning routines and going shopping with children)
- Parents will be provided with practical strategies on how to manage high risk situations by giving them step by step instructions on what to do before, during and after an event.
- Parents will learn about practical strategies they can apply in order to manage sibling conflict, such as rewarding/ disciplining siblings as a team

Module 5 (Optional Module): Working as a Team
- Common sources of disagreement between parents will be outlined
- Parents will be given practical advice about: 1. what they can do when their child misbehaves whilst two adults are present; 2. How to have brief discussions together; 3. problem solving discussions
- The importance of spending quality time together and practical ways to achieve this will be discussed
- The psychologist will provide tips to separated/divorced parents

Module 6: Review and Preventing Future Problems
- Information presented on key strategies to maintain changes
- Parents will be provided with a summary of the key points and strategies provided in modules 2 to 5
- Parents will then be reminded that they have the option to complete the additional modules and download the tip sheets available
- Parents prompted to complete the post-assessment and reminded they will receive feedback on this when they have done so
- Next, parents will be informed that they will receive a text and/or email reminder regarding the 3 month questionnaires they will be asked to complete

Module 7 (Optional Module): Encouraging Child Development through Quality Time and Play
- Information will be presented about what spending quality time with children involves
- The developmental benefits of playing with children (e.g., cognitive, social, emotional and physical) will be outlined
- Parents will be provided with information about, and practical strategies to carry out, Child Directed Play

Module 8 (Optional Module): Bully-Proofing Your Child
- The various forms of bullying will be defined (e.g., verbal, psychological and social)
- The effects of bullying on the victim, bully and witnesses will be discussed
- Strategies parents can use to reduce the chances of their child being bullied and what they can do if their child is being bullied will be discussed
- How to carry out problem solving discussions with children if they disclose that they are being bullied
- Parents will then be provided with strategies they can use to reduce the likelihood that their child will bully others
- Signs that may indicate that their child is bullying others, why children might bully others as well as what parents can do if their child is bullying others


***Mode of delivery***
All online with option to print physical copies of some materials if desired. No face-to-face contact. Parents can choose to complete the intervention alone or with their partner (or other adult who is involved in parenting).


***Intervention dose***
The 5-8 modules will be completed over a 4-8 week period at the parents' own pace. Parents can take as long as they like to complete the program and can also put the program on hold for as long as they choose. Each module takes 20-30 minutes to complete. Modules 1 and 2 can be completed on the same day. There is a one-week break in between each of Modules 2, 3, 4, 5 and 6. During the one-week breaks, there are practice exercises to be completed, which relate to the module content. After Module 6, Modules 7 and 8 become available immediately and can be completed at any time. All intervention content can be revisited at any time until three months post-intervention.


***Location***
The intervention can be completed online at locations of the participants' choice.


***Personalisation of intervention***
The content of the modules will not differ between individuals completing the intervention. However, based on participants baseline questionnaire responses, participants might receive a recommendation to complete the optional Module 5. This recommendation will occur if parents indicate that they experience disagreements surrounding childrearing issues.


***Fidelity***
Fidelity is not relevant as it is an online intervention.
Intervention code [1] 295121 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298729 0
Child emotional/behavioural adjustment will be assessed using scores on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997). This measure will be completed by parents participating in the program.
Timepoint [1] 298729 0
1. Baseline
2. Immediately post-intervention
3. Three-months post-intervention
Primary outcome [2] 298730 0
Disagreements between parents over childrearing issues will be assessed using scores on the Parent Problem Checklist (PPC; Dadds & Powell, 1991).
Timepoint [2] 298730 0
1. Baseline
2. Immediately post-intervention
3. Three-months post-intervention
Primary outcome [3] 298731 0
Dysfunctional and positive parenting will be assessed using scores on the Parenting and Family Adjustment Scales (PAFAS; Sanders et al, 2003).
Timepoint [3] 298731 0
1. Baseline
2. Immediately post-intervention
3. Three-months post-intervention
Secondary outcome [1] 325083 0
Parent mental health as assessed using scores on the K6 (Kessler et al, 2003).
Timepoint [1] 325083 0
1. Baseline
2. Immediately post-intervention
3. Three-months post-intervention
Secondary outcome [2] 325087 0
Relationship satisfaction as measured by scores on a single item from Abbreviated Dyadic Adjustment Scale (Sharpely & Rogers, 1984).
Timepoint [2] 325087 0
1. Baseline
2. Immediately post-intervention
3. Three-months post-intervention
Secondary outcome [3] 325148 0
Father engagement in the program as assessed by number of views of each module and completion of 'putting it into practice' homework exercises.
Timepoint [3] 325148 0
Immediately post-intervention

Eligibility
Key inclusion criteria
- Parent or caregiver of child aged 2-16 years
- Aged 18 and over
- Lives in Australia
- Ability to complete questionnaires and understand program content in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Aged under 18 years
- Lives outside Australia
- Not able to complete questionnaires or understand program content in English

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Estimation
The Sample Size estimate was conducted with G*power. To detect a small effect of father engagement in the parenting program on child outcomes (d = 0.2, with 0.8 power) we estimate that we will need 800 two-parent families, of which we expect approximately 400 fathers will elect to participate. We aim to recruit at least 1200 families. We estimate that approximately 20% of families will drop out after commencement of the program. Of the remaining 960 families, we expect approximately 160 will be single-parent families and 800 will be two-parent families.

Statistical Analysis Plan
Statistical approach will be data-driven and will include a range of within subjects analysis (e.g., repeated measures t-tests) to detect changes over the three time points, as well as between subjects analysis (e.g., t-test/ANOVA) to examine effects of father engagement. We will also apply a range of regression-based techniques (including SEM) to test predictors, moderators, and mediators of program effectiveness. The outlined analyses will be conducted in SPSS, R and Mplus.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
5/09/2016
Date of last participant enrolment
Anticipated
31/10/2019
Actual
Date of last data collection
Anticipated
31/01/2020
Actual
Sample size
Target
8000
Accrual to date
4600
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293907 0
Charities/Societies/Foundations
Name [1] 293907 0
Movember Foundation
Country [1] 293907 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 292732 0
None
Name [1] 292732 0
Address [1] 292732 0
Country [1] 292732 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295324 0
The University of Sydney's Human Research Ethics Committee
Ethics committee address [1] 295324 0
Ethics committee country [1] 295324 0
Australia
Date submitted for ethics approval [1] 295324 0
22/04/2016
Approval date [1] 295324 0
07/06/2016
Ethics approval number [1] 295324 0
2016/452

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

Contacts
Principal investigator
Name 66870 0
Prof Mark Dadds
Address 66870 0
School of Psychology
University of Sydney
Camperdown
NSW 2006
Country 66870 0
Australia
Phone 66870 0
+61 2 8627 4583
Fax 66870 0
Email 66870 0
[email protected]
Contact person for public queries
Name 66871 0
Mark Dadds
Address 66871 0
School of Psychology
University of Sydney
Camperdown
NSW 2006
Country 66871 0
Australia
Phone 66871 0
+61 2 8627 4583
Fax 66871 0
Email 66871 0
[email protected]
Contact person for scientific queries
Name 66872 0
Mark Dadds
Address 66872 0
School of Psychology
University of Sydney
Camperdown
NSW 2006
Country 66872 0
Australia
Phone 66872 0
+61 2 8627 4583
Fax 66872 0
Email 66872 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
There is no plan to share the data.


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
SourceTitleYear of PublicationDOI
EmbaseParentWorks: Evaluation of an Online, Father-Inclusive, Universal Parenting Intervention to Reduce Child Conduct Problems.2020https://dx.doi.org/10.1007/s10578-019-00934-0
N.B. These documents automatically identified may not have been verified by the study sponsor.