Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001355763
Ethics application status
Approved
Date submitted
15/10/2022
Date registered
21/10/2022
Date last updated
21/10/2022
Date data sharing statement initially provided
21/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Online Parent Treatment Modules for Gaming Disorder
Scientific title
Online Parent Treatment Modules: Parent education and behaviour management strategies for Gaming and Screen Disorder and overuse. Investigating the efficacy of online modules on children screen time and developmental impacts.
Secondary ID [1] 308180 0
NA
Universal Trial Number (UTN)
U1111-1283-9789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gaming Disorder 327904 0
Hazardous Gaming 327905 0
Internet Gaming Disorder 327906 0
Problematic Screen Use 327907 0
Condition category
Condition code
Mental Health 324990 324990 0 0
Addiction
Mental Health 324991 324991 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive access to a series of short parent education video modules delivered by Brad Marshall (co-author of this study and Registered Psychologist). Part One of the series will provide psychoeducation around screen addiction and identify psychological “underpinnings” associated with overuse. Part Two outlines the seven-step model for parent intervention outlined in the parenting book The Tech Diet for your Child and Teen (Marshall, 2019). Both Part One and Two will be available immediately upon the participant accessing the website. These strategies involve parents focusing on managing WIFI connection to devices as opposed to traditional advice on "taking" a physical screen. The strategies also outline how to negotiate and agree on a WIFI screen daily plan with their child. In the first two weeks parents are asked to watch the video series that is approximately 90 minutes in length and platform that hosts the video series tracks whether a participant has watched the video which allows for measuring treatment compliance. Parents will then be asked to implement these strategies at home over a 6-week period.

Participants will be recruited online and via social media advertisements targeting parents that are seeking or worried about their child's screen use and would like to be more proactive in setting parent boundaries.
Intervention code [1] 324627 0
Treatment: Other
Intervention code [2] 324628 0
Behaviour
Comparator / control treatment
Control group will consist of those participants who at 6 week follow up indicate they did not implement any of the strategies in the parent modules over that period. They will be asked to complete the same survey data as the "treatment" group. This will be an Treatment as Usual or "standard care" group that are free to access alternate options as they would have naturally.
Control group
Active

Outcomes
Primary outcome [1] 332800 0
Average Recreational Daily Screen Use (number of hours over two week period divided by 14) which is calculated via the online questionnaire prompting the parent to estimate the previous two week period (by each day) and complete the number of hours associated.

EG. 1. On a typical weekday in the last two weeks how long do you/your child spend of the following devices:
Computer/Laptop: ___ Hours and ____ Mins
Tablet (EG. IPad): ___ Hours and ____ Mins
Console (EG Xbox, Playstation, Switch etc) ___ Hours and ____ Mins
Smart Phone: ___ Hours and ____ Mins
TV: ___ Hours and ____ Mins
Timepoint [1] 332800 0
1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up
Primary outcome [2] 332801 0
Impact on child developmental domains (emotional wellbeing, social, physical health, behaviour and education) as measured by a Screens and Developmental Impact Questionnaire
Timepoint [2] 332801 0
1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up
Primary outcome [3] 332802 0
Level of Internet Gaming Disorder (IGD) symptoms as measured by composite of the parent report IGD-10 and the Smartphone Application Based Addiction Scale (SABAS)
Timepoint [3] 332802 0
1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up
Secondary outcome [1] 414729 0
Level of Sleep Disturbance as measured by the Sleep Disturbances Scale for Children
Timepoint [1] 414729 0
1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up

Eligibility
Key inclusion criteria
All participants of this study will be parents/guardians who are recruited via online and social media advertising. These parents/guardians will self-identify as having at least one child with what they consider "problematic" screen/gaming use or parents that identify wanting to help their child find a healthy screens/gaming balance.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Those who are seeking assistance for children outside of school-age (5-18 years) will be excluded as these are "parent management strategies" that are not designed for parents young adults.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample: Aiming to recruit 1,000 parents.

Mixed ANOVAS will be used to determine if there are changes over time across the dependent variables, and whether these changes differ between the treatment groups. Moderation by gender, age and demographics will also be analysed. Relationships between outcomes, and between predictors and outcomes will also be assessed via correlational and regression analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2022
Actual
Date of last participant enrolment
Anticipated
1/03/2024
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 38751 0
2065 - Greenwich

Funding & Sponsors
Funding source category [1] 312436 0
Self funded/Unfunded
Name [1] 312436 0
Country [1] 312436 0
Primary sponsor type
University
Name
Macquaire University
Address
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 314013 0
Other
Name [1] 314013 0
Screens and Gaming Disorder Clinic
Address [1] 314013 0
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country [1] 314013 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311784 0
Macquarie University Human Research Ethics Committee (Humanities and Social Science)
Ethics committee address [1] 311784 0
Ethics committee country [1] 311784 0
Australia
Date submitted for ethics approval [1] 311784 0
02/11/2020
Approval date [1] 311784 0
19/01/2021
Ethics approval number [1] 311784 0
52020930522995

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

Contacts
Principal investigator
Name 122350 0
A/Prof Wayne Warburton
Address 122350 0
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Country 122350 0
Australia
Phone 122350 0
+61 2 98508643
Fax 122350 0
Email 122350 0
[email protected]
Contact person for public queries
Name 122351 0
Brad Marshall
Address 122351 0
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country 122351 0
Australia
Phone 122351 0
+61 2 82871242
Fax 122351 0
Email 122351 0
[email protected]
Contact person for scientific queries
Name 122352 0
Brad Marshall
Address 122352 0
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country 122352 0
Australia
Phone 122352 0
+61 2 82871242
Fax 122352 0
Email 122352 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?
De-identified and reduced data set with groups and key outcomes
When will data be available (start and end dates)?
2025 start date (within 18 months of last data collection) and then ongoing (no end date as it will be in Repository)
Available to whom?
Other academic and researchers who have gained Ethics Committee approval and then applied to the repository for access to this 'sensitive' data set.
Available for what types of analyses?
Any research approved by an Ethics Committee
How or where can data be obtained?
It will be uploaded to Australian Data Archive (Repository) https://ada.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17354Ethical approval  [email protected]
17355OtherAustralian Data Archivehttps://ada.edu.au/  Meta Data records along with the de-identified dat... [More Details]



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.