Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000581662
Ethics application status
Approved
Date submitted
9/05/2023
Date registered
29/05/2023
Date last updated
29/05/2023
Date data sharing statement initially provided
29/05/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of playful discipline taught in an attachment-based parenting program
Scientific title
A randomised controlled dismantling study on playful discipline in an attachment-based parenting program with parents or primary caregivers in Australia
Secondary ID [1] 309626 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parental well-being 329945 0
Ineffective parent behaviour to elicit child attachment behaviour 329946 0
Challenging child behaviour 329947 0
Low feelings of parental self efficacy 329948 0
Low feelings of parental empowerment 330161 0
Condition category
Condition code
Public Health 326854 326854 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed as a 12-week RCT trial with an active control group. At baseline, participants in the treatment group will receive a single 3-hour introductory session (online) of the Aware Parenting program. The program teaches parents responsive parenting skills and playful discipline. The session will be delivered by a trained Aware Parenting facilitator who is also trained in psychosynthesis. The workshop will meet in small groups of 3-10 participants. It will be a combination of lecture style (teaching to slides) and demonstrations as well as giving the participants chances to ask questions and share experiences.

Some of the responsive skills parents will learn are: reasons why their child may be behaving in certain ways, such as not cooperating or crying. Reasons for misbehaviour will include that the child is lacking information or that the child has an unmet emotional or physical need. Participants in the treatment group will be taught playful discipline as both a prevention and present time remedy for challenging behaviour. Some games parent will be taught are called 'power reversal games', an example could be 'the exaggeration game' exaggerate about something that is going on. For example, if a child won’t come out of the house, the parent could pretend that you need a whole team of people to help you, and gather a team of superheroes who all try to do magic things to help him leave. Another strategy will be the use of 'present time', which is another name for 'Non-directive Child Centred Play'.

At week 4, parents will be invited to a 1 hour Zoom follow-up call. At week 8 they will receive a follow-up phone call. The phone call is estimated to last 10-15 minutes. Parenting support via email, text or phone call will be provided if needed throughout the 12 weeks. Support as needed will be provided by answering parenting questions about their child's behaviour and also where they may find resources, such as websites and videos from aware parenting instructors. If the parent is struggling in any other domain (emotional, physical) they will be directed to the relevant resources available (i.e., government websites, hotlines, emergency). A psychologist will be on the team to consult with if needed.

Participant adherence to the intervention will be noted in the engagement level of the follow up call and the follow up phone call. If participants do not attend one of the 3 hour sessions in the first week or 10 days of the start of the study, they will not be eligible to continue with the study.

Survey data will be collected at baseline and week 12.
Intervention code [1] 326053 0
Behaviour
Comparator / control treatment
The control group will receive the same treatment as the intervention group but without the playful discipline aspect and without present time. At baseline, participants in the treatment group will receive a single 3-hour introductory session (online) of the Aware Parenting program. This variation of the program will teach parents responsive parenting skills but not playful discipline. At week 4, parents will be invited to a 1 hour Zoom follow-up call. At week 8 they will receive a follow-up phone call. Parenting support via email, text or phone call will be provided if needed throughout the 12 weeks. Survey data will be collected at baseline and week 12.
Control group
Active

Outcomes
Primary outcome [1] 334706 0
Changes in the child's behaviour as measured by the Strengths and Difficulties Questionnaire (SDQ) compared with a control group. (primary outcome). The difference between the SDQ means for the treatment group will be compared with the control group.
Timepoint [1] 334706 0
Baseline and 12 weeks after intervention.
Primary outcome [2] 334707 0
Changes in the treatment group in the parent's efficacy and empowerment as measured by the Parent Efficacy and Empowerment Measure (PEEM). (primary outcome). The difference between the PEEM means for the treatment group will be compared with the control group.
Timepoint [2] 334707 0
Baseline and 12 weeks after intervention.
Secondary outcome [1] 421818 0
Changes in the parent's report of their child's attachment style as measured by the Attachment Relationship Inventory – Caregiver Perception (ARI-CP).
Timepoint [1] 421818 0
Baseline and 12 weeks after intervention.
Secondary outcome [2] 421819 0
Changes in the treatment group will measure parent's well-being as measured by the Warwick-Edinburgh Mental Well-being Scale (WEWBS).
Timepoint [2] 421819 0
Baseline and 12 weeks after intervention.

Eligibility
Key inclusion criteria
Participants will be parents or primary caregivers residing in Australia over 18 years with children aged 2-4 years old who have not learned this parenting intervention before.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Severe diagnosed neurodevelopment or personality disorders in the parent or child that impacts daily life.
On-going severe depression or anxiety diagnosis in the parent.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes - allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We have used permuted block design with block sized of 2,4 and 6 to achieve reasonable balance across treatments and to ensure that concealment of the allocation sequence will be maintained. Also, permuted block randomisation was used to avoid choosing the last participant in block by algorithm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size
A sample size was calculated from pilot study data based on the difference between the means (MD=9.3, SD=16.3) of the PEEM pre- and post-scores from both groups in the pilot study. For a study with 95% power, at least 42 participants should be recruited in the final analysis. Attrition rates in the pilot study were around 29%. Steps have been taken to minimise attrition rates, such as by providing a more engaging placebo condition and also an alternate date for the delivery of the program intervention. Therefore, for a study with 95% power, 50 participants at randomisation should allow for an anticipated 20% dropout rate. Sample size calculations were done in R studio (version 4.2.2) in pwr library.

Analysis
Linear mixed effects modelling will be used to analysis the survey data to determine if there is a significant difference between mean group scores for each measurement tool. Interview data will be analysed using thematic analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/05/2023
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
30/08/2023
Actual
Sample size
Target
50
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313807 0
University
Name [1] 313807 0
Southern Cross University
Country [1] 313807 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
Gold Coast Airport, Terminal Dr, Bilinga QLD 4225
Country
Australia
Secondary sponsor category [1] 315644 0
None
Name [1] 315644 0
Address [1] 315644 0
Country [1] 315644 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312971 0
Southern Cross University Human Research Ethics Committee
Ethics committee address [1] 312971 0
Ethics committee country [1] 312971 0
Australia
Date submitted for ethics approval [1] 312971 0
16/01/2023
Approval date [1] 312971 0
07/02/2023
Ethics approval number [1] 312971 0
2023/009

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

Contacts
Principal investigator
Name 126534 0
Mrs Kathryn Baltrotsky
Address 126534 0
Gold Coast Airport, Terminal Dr, Bilinga QLD 4225
Country 126534 0
Australia
Phone 126534 0
+61 416598984
Fax 126534 0
Email 126534 0
[email protected]
Contact person for public queries
Name 126535 0
Kathryn Baltrotsky
Address 126535 0
Gold Coast Airport, Terminal Dr, Bilinga QLD 4225
Country 126535 0
Australia
Phone 126535 0
+61 416598984
Fax 126535 0
Email 126535 0
[email protected]
Contact person for scientific queries
Name 126536 0
Kathryn Baltrotsky
Address 126536 0
Gold Coast Airport, Terminal Dr, Bilinga QLD 4225
Country 126536 0
Australia
Phone 126536 0
+61 416598984
Fax 126536 0
Email 126536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de-identification, raw data may be shared upon request.
When will data be available (start and end dates)?
Data will be made available after publication and will be held on a password protected computer for 5 years after data collection.
Available to whom?
Data will only researchers who provide a methodologically sound proposal to view this data.
Available for what types of analyses?
For meta-analysis
How or where can data be obtained?
Data will be stored in a data depository provided by Southern Cross University and will be made available upon request from the author.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19124Ethical approval  [email protected] 385869-(Uploaded-09-05-2023-12-49-59)-Study-related document.pdf
19125Informed consent form  [email protected] 385869-(Uploaded-09-05-2023-12-51-59)-Study-related document.pdf
19126Study protocol  [email protected]
19127Statistical analysis plan  [email protected]
19128Clinical study report  [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.