Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000768796
Ethics application status
Approved
Date submitted
17/05/2022
Date registered
30/05/2022
Date last updated
8/05/2023
Date data sharing statement initially provided
30/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Parent education and behavioural management interventions for Screens and Gaming Disorder in children
Scientific title
Parent education and behavioural management strategies for children with clinical and at risk levels of excessive screen use and Gaming Disorder
Secondary ID [1] 307114 0
NA
Universal Trial Number (UTN)
U1111-1278-2026
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gaming Disorder 326274 0
Hazardous Gaming 326275 0
Internet Gaming Disorder 326276 0
Problematic Screen Use 326277 0
Condition category
Condition code
Mental Health 323584 323584 0 0
Addiction
Mental Health 323585 323585 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Group

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). 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.



Intervention code [1] 323566 0
Treatment: Other
Intervention code [2] 323567 0
Behaviour
Comparator / control treatment
In the new Feasibility Trial model there will be no official "control group" assignment. Those participants who do not watch all/some of the videos, and/or who don't implement any of the strategies, and/or who don't implement the strategies for the full 6 weeks will be compared to the group that is fully or partially compliant
Control group
Dose comparison

Outcomes
Primary outcome [1] 331340 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] 331340 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Primary outcome [2] 331341 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] 331341 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Primary outcome [3] 331342 0
Level of Internet Gaming Disorder symptoms as measured by composite of the parent report IGD-10 and the Smartphone Application Based Addiction Scale (SABAS)
Timepoint [3] 331342 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Secondary outcome [1] 409572 0
Level of Sleep Disturbance as measured by the Sleep Disturbances Scale for Children
Timepoint [1] 409572 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Secondary outcome [2] 409573 0
Parent and child attachment and conflict levels as measured by Parent-Family Connectedness Scale
Timepoint [2] 409573 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Secondary outcome [3] 409574 0
Levels of Anxiety or Depression symptoms (normal, elevated, sub-clinical or clinical) as measured by the Revised Children's Anxiety and Depression Scale (RCADS) parent report
Timepoint [3] 409574 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up

Secondary outcome [4] 410031 0
Parent and child attachment and conflict levels as measured by Child Negative Events Screening scale
Timepoint [4] 410031 0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up

Eligibility
Key inclusion criteria
All participants in this study will be invited post a school based screening questionnaire from a earlier study. This will identify "at risk and clinical" levels of screen and gaming use, and invite those parents to participate.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any child who displays clinical levels of co-morbid psychopathology (Depression, Anxiety etc) will be excluded if they are not currently under the care of a health practitioner able to monitor their mental state during this program,

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
Open (masking not used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Single group
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Initial sample: 1993 (school sample)
Estimated prevalence of sub-sample: 10%.
Estimated invitations: 200
Estimated participants: 50-100


The school sample of approximately 2,000 Australian children will identify (based on previous studies) approximately 10% of children that are "at risk" on the measures described earlier.
Mixed ANOVAS will be used to determine if there are changes over time across the dependent variables, and whether these changes differ between the dosage 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
9/05/2023
Actual
Date of last participant enrolment
Anticipated
30/11/2023
Actual
Date of last data collection
Anticipated
1/07/2024
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 37517 0
2065 - Greenwich

Funding & Sponsors
Funding source category [1] 311420 0
Self funded/Unfunded
Name [1] 311420 0
Country [1] 311420 0
Primary sponsor type
University
Name
Macquarie University
Address
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Country
Australia
Secondary sponsor category [1] 312812 0
Other
Name [1] 312812 0
Screens and Gaming Disorder Clinic
Address [1] 312812 0
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country [1] 312812 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310900 0
Macquaire University Human Research Ethics Committee (HREC) (Medical Sciences)
Ethics committee address [1] 310900 0
Research Services | Ground Floor, 16 Wally's Walk
Macquarie University, NSW 2109, Australia
Ethics committee country [1] 310900 0
Australia
Date submitted for ethics approval [1] 310900 0
16/05/2022
Approval date [1] 310900 0
01/07/2022
Ethics approval number [1] 310900 0
520221167539476

Summary
Brief summary
The objective of the current study is to conduct a Feasibility Trial (FT) for a treatment intervention involving parents of children and young adolescents with a screen-based disorder, or with problematic patterns of screen use.
Parents of children and adolescents identified as “at risk” of Internet Gaming Disorder (IGD) or Problematic Screen Use will be invited to take part in the FT.

Hypotheses:

1. Given that it is expected a number of parents will not be able to implement the program for the full 6 weeks, it is expected that those who complete will have better results than those who partially complete. That is, that parents who are able to implement the treatment model for all 6 weeks post intervention, compared to those parents who implemented strategies for under 2 weeks and those who implemented them for between 3-6 weeks, will report a greater decrease in child screen use and significantly stronger improvement in their child’s wellbeing as measured by reduced family conflict, improved behaviour, sleep, exercise, social engagement with peers and schoolwork.
2. That children with high levels of Internet Gaming as measured by clinically significant score on the IGD-10 (5+) and/or high/problematic levels on the IGD-10, SABAS and BSMAS (24+) prior to intervention, will report an initial increase in family conflict followed by a steady reduction once the parent strategies are in place.
3. That the parenting intervention strategies employed by the active treatment group will be more effective in the younger sample than in the teenage sample. This hypothesis is based on previous research (Marshall et al., 2022) where we found preliminary evidence for increased IGD symptoms after children start high school and on the basis that teenagers are individuating and therefore less likely to willingly comply with parent rules than primary school children.
4. That parenting strategies will be more effective for children that have ‘at risk’ or sub-clinical presentations rather than clinical levels of IGD/GD, as children and teenagers who meet criteria the full clinical disorder criteria may be more resistant to intervention, more ‘driven’ by the “addiction”, and potentially lacking insight into their disorder.
5. That participants whose parents receive the text message ‘nudge’ will maintain treatment gains longer and/or more consistently than participants who do not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119278 0
A/Prof Wayne Warburton
Address 119278 0
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Country 119278 0
Australia
Phone 119278 0
+61 2 9850 8643
Fax 119278 0
Email 119278 0
wayne.warburton@mq.edu.au
Contact person for public queries
Name 119279 0
Mr Brad Marshall
Address 119279 0
Brad Marshall
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country 119279 0
Australia
Phone 119279 0
+61 02 8287 1242
Fax 119279 0
Email 119279 0
bradley.marshall@hdr.mq.edu.au
Contact person for scientific queries
Name 119280 0
Mr Brad Marshall
Address 119280 0
Brad Marshall
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Country 119280 0
Australia
Phone 119280 0
+61 02 8287 1242
Fax 119280 0
Email 119280 0
bradley.marshall@hdr.mq.edu.au

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
16019Other https://ada.edu.au  Australian Data Archive
16020Ethical approval  Wayne.warburton@mq.edu.au MQ Ethics Approval submitted on 16.05.22 and await... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.