Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001032741
Ethics application status
Approved
Date submitted
20/07/2022
Date registered
25/07/2022
Date last updated
1/12/2023
Date data sharing statement initially provided
25/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of a brief online parenting program on child behaviour, dysfunctional parenting, and parent well-being
Scientific title
Evaluating the efficacy of Family Man: a self-directed online parenting program targeting child behaviour, dysfunctional parenting, and parent well-being
Secondary ID [1] 307554 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child behavioural disorders 326993 0
Parental mental health 326994 0
Condition category
Condition code
Mental Health 324181 324181 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are parents of children aged between 2 and 8 years 11 months of age who are referred (or self-refer) to the Sydney Child Behaviour Research Clinic, and would like assistance managing child disruptive behaviour. The aim of this study is to conduct a RCT of Family Man, a brief, self-directed online parenting program (OPP) that provides parents with evidence-based strategies to manage challenging child behaviour, promote positive parent-child interactions, and support parental teamwork.

Participants who meet inclusion criteria will complete a baseline assessment, which will involve completing online questionnaires. Once baseline assessment has been completed, participants will be randomly allocated to the OPP group or to the waitlist control group.

Participants randomly allocated to the OPP group will receive access to the website containing the intervention, called Family Man. Family Man is a brief self-directed, online parenting program that is comprised of three modules. The Family Man program has been developed from other evidence-based programs and includes three modules covering strategies to encourage positive behaviour and use rewards (Module 1), manage challenging behaviour and implement consistent effective discipline (Module 2), and generalising parenting strategies to manage high-risk situations (Module 3). The intervention has been designed to be engaging for fathers, who have low rates of participation in parenting interventions. The core intervention content is delivered via three, short (20 minute), animated video episodes, which are embedded with ‘choose-your-own-adventure’-style questions. At the end of each video episode, parents can access additional written content that is relevant to the topics covered in the video episode. For each module, this written content includes a ‘Crash Course’ summarising the key information in the video episode, and a ‘Toolkit’ of tips for implementing the strategies. The three modules will be gradually released, such that after completing one episode, participants will have to wait one week before they can access the next module’s episode and additional content, to provide some time for parents to implement the strategies. In addition to the intervention modules, Family Man contains articles covering a range of topics related to child development, behaviour, and parenting. The 'Crash Course', 'Toolkit' and articles have been designed specifically for the Family Man intervention/study. Parents can access the OPP using a smart phone, tablet, or computer at a time that suits them. Two-parent families are strongly encouraged to complete the OPP together, as research shows this leads to the best outcomes for parents and children.

To assess intervention adherence, program user-data (e.g., number of log-ins, pages visited, time between log-ins) will be collected from the OPP site. Parents will also complete a questionnaire about program use and implementation at the post-assessment, following intervention completion. During the four-week intervention period, the trial manager will send weekly email prompts to parents in the OPP group, to remind them to complete each of the three modules.

All participants will receive the intervention. Participants randomly allocated to the waitlist control group will be required to wait for 4 weeks before receiving the OPP. All participants will be asked not to participate in any other parenting programs during the waiting/intervention period. All families will be assessed pre- and post-program (or waitlist) and the OPP group will also be assessed at two month follow-up.
Intervention code [1] 324015 0
Behaviour
Comparator / control treatment
Parents randomly allocated to the waitlist control group will wait for 4 weeks before receiving the online parenting intervention (i.e., Family Man). The waitlist group will be requested not to complete any parenting programs during the waiting period.
Control group
Active

Outcomes
Primary outcome [1] 331991 0
Child externalising behaviours will be assessed with the Intensity and Problem scales of the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [1] 331991 0
The ECBI will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [1] 412074 0
Child emotional and behavioural symptoms will be assessed with the total difficulties score and the conduct problems subscale score on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [1] 412074 0
The SDQ will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [2] 412075 0
Dysfunctional parenting will be assessed using the Parenting Scale of the Parenting and Family Adjustment Scales (PAFAS; Sanders, Morawska, Haslam, Filus & Fletcher, 2014), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [2] 412075 0
The Parenting Scale of the PAFAS will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [3] 412077 0
Parents’ sense of competence will be assessed with the Efficacy scale on the Parenting Sense of Competence Scale (PSOC; Johnston & Mash, 1989), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [3] 412077 0
The Efficacy scale of the PSOC will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [4] 412078 0
Inter-parental conflict/teamwork between parents who operate as parenting teams will be assessed with the Intensity and Problem scales on the Parent Problem Checklist (PPC; Dadds & Powell, 1991), a parent-report measure completed by all participating parents (both mothers and fathers) in two-parent families.
Timepoint [4] 412078 0
The PPC will be administered at baseline, and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [5] 412079 0
Parents’ feelings about their role as a parent in terms of rewards and satisfaction as well as stress and uncertainty will be assessed with the Parental Stress Scale (PSS; Berry & Jones, 1995), a parent-completed measure completed by all participating parents (both mothers and fathers). The total parental stress score will be used.
Timepoint [5] 412079 0
The PSS will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [6] 412080 0
Parental well-being will be assessed using the 6-item version of the Kessler Psychological Distress Scale (K6; Furukawa, Kessler, Slade & Andrews, 2003), a self-report global measure of depressive and anxiety-related symptomology. The K6 will be completed by all participating parents (both mothers and fathers).
Timepoint [6] 412080 0
The K6 will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.
Secondary outcome [7] 412081 0
Levels of disorganisation and confusion in the child’s household environment will be assessed using the six-item version of the Confusion, Hubbub, and Order Scale (CHAOS; Matheny, Wachs, Ludwig & Phillips, 1995). The CHAOS will be completed by all participating parents (both mothers and fathers).
Timepoint [7] 412081 0
The CHAOS will be administered at baseline and post-assessment (intervention, waitlist control), and two-month follow-up (intervention group only). Post- assessment occurs 4 weeks after randomisation, and two-month follow-up occurs 2 months after post-assessment.

Eligibility
Key inclusion criteria
Inclusion criteria include: 1. Parents/caregivers of children aged 2 to 8 years 11 months; 2. Parents would like assistance in managing their child’s disruptive behaviours; 3. Parents must be able to access high speed internet via computer, tablet, or smart phone to participate in the online parenting program and complete research questionnaires; 4. If child is receiving medication for emotional/behavioural problems, must be stable on current dose for 4 weeks, with no planned changed to medication regime.
Minimum age
24 Months
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Key exclusion criteria are: 1. Child has an intellectual disability, Autism Spectrum Disorder, or pervasive developmental disability; 2. Parent is unable to complete questions and understand program content in English; 3. Family are currently receiving or planning to receive another parenting program or treatment by a psychologist; 4. Family is experiencing domestic violence, child protection issues, or severe parental mental illness/substance use, or is subject to court orders regarding parenting. 5. Family have previously completed this OPP.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to treatment condition will be concealed to researchers by using a central randomisation procedure on the trial’s REDCap system : Once participants have completed the baseline assessment, the trial manager will initiate random allocation to either the online parenting intervention (OPP) or waitlist using the in-built randomisation feature on REDCap. This procedure will ensure concealment of treatment allocation as well as an audit trail for confirming allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation sequence will be generated using Robust Randomisation App (RRApp; Tu & Benn, 2018), which is an online tool . The sequence will be imported into the trial’s REDCap system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A priori power analysis was performed using G*Power software to determine a reasonable sample size for the study. Based on repeated-measures MANOVA with within-between interactions, two groups, with two primary outcome measures and two measurement time points, a total sample size of 100 is sufficient to detect a small-to-moderate effect size of 0.3, using power = 0.8, and a Type I error rate of 0.05 (consistent with convention).

To test the efficacy of the OPP, repeated measures MANOVAs will be conducted for each group of outcome measures, with treatment group as a between-subjects factor and timepoint (pre-, post-) as a within-subjects factor. A second set of repeated measures MANOVAs with timepoint as a within-subjects factor will be conducted to assess longer term intervention effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/01/2024
Actual
Date of last participant enrolment
Anticipated
25/07/2024
Actual
Date of last data collection
Anticipated
1/01/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 38084 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 311827 0
Charities/Societies/Foundations
Name [1] 311827 0
Movember Foundation
Country [1] 311827 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 313302 0
None
Name [1] 313302 0
Address [1] 313302 0
Country [1] 313302 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311271 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 311271 0
Ethics committee country [1] 311271 0
Australia
Date submitted for ethics approval [1] 311271 0
04/07/2022
Approval date [1] 311271 0
02/09/2022
Ethics approval number [1] 311271 0

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

Contacts
Principal investigator
Name 120522 0
Prof Mark Dadds
Address 120522 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 120522 0
Australia
Phone 120522 0
+61 2 9114 4321
Fax 120522 0
Email 120522 0
[email protected]
Contact person for public queries
Name 120523 0
Adrienne Turnell
Address 120523 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 120523 0
Australia
Phone 120523 0
+61 2 9114 4326
Fax 120523 0
Email 120523 0
[email protected]
Contact person for scientific queries
Name 120524 0
Adrienne Turnell
Address 120524 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 120524 0
Australia
Phone 120524 0
+61 2 9114 4326
Fax 120524 0
Email 120524 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


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.