Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Parent education and behavioural management strategies for children with clinical and at risk levels of excessive screen use and Gaming Disorder
Query!
Secondary ID [1]
307114
0
NA
Query!
Universal Trial Number (UTN)
U1111-1278-2026
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Gaming Disorder
326274
0
Query!
Hazardous Gaming
326275
0
Query!
Internet Gaming Disorder
326276
0
Query!
Problematic Screen Use
326277
0
Query!
Condition category
Condition code
Mental Health
323584
323584
0
0
Query!
Addiction
Query!
Mental Health
323585
323585
0
0
Query!
Other mental health disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
323566
0
Treatment: Other
Query!
Intervention code [2]
323567
0
Behaviour
Query!
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
Query!
Control group
Dose comparison
Query!
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
Query!
Assessment method [1]
331340
0
Query!
Timepoint [1]
331340
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
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
Query!
Assessment method [2]
331341
0
Query!
Timepoint [2]
331341
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
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)
Query!
Assessment method [3]
331342
0
Query!
Timepoint [3]
331342
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
Secondary outcome [1]
409572
0
Level of Sleep Disturbance as measured by the Sleep Disturbances Scale for Children
Query!
Assessment method [1]
409572
0
Query!
Timepoint [1]
409572
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
Secondary outcome [2]
409573
0
Parent and child attachment and conflict levels as measured by Parent-Family Connectedness Scale
Query!
Assessment method [2]
409573
0
Query!
Timepoint [2]
409573
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
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
Query!
Assessment method [3]
409574
0
Query!
Timepoint [3]
409574
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
Secondary outcome [4]
410031
0
Parent and child attachment and conflict levels as measured by Child Negative Events Screening scale
Query!
Assessment method [4]
410031
0
Query!
Timepoint [4]
410031
0
1. Pre-treatment 2. Post-Treatment (six weeks) - Primary End Point 3. 3 month follow up
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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,
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
NA
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
9/05/2023
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
30/11/2023
Query!
Actual
Query!
Date of last data collection
Anticipated
1/07/2024
Query!
Actual
Query!
Sample size
Target
200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW
Query!
Recruitment postcode(s) [1]
37517
0
2065 - Greenwich
Query!
Funding & Sponsors
Funding source category [1]
311420
0
Self funded/Unfunded
Query!
Name [1]
311420
0
Query!
Address [1]
311420
0
Query!
Country [1]
311420
0
Query!
Primary sponsor type
University
Query!
Name
Macquarie University
Query!
Address
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Query!
Country
Australia
Query!
Secondary sponsor category [1]
312812
0
Other
Query!
Name [1]
312812
0
Screens and Gaming Disorder Clinic
Query!
Address [1]
312812
0
20/130-134 Pacific Highway
Greenwich
NSW 2065
Query!
Country [1]
312812
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
310900
0
Macquaire University Human Research Ethics Committee (HREC) (Medical Sciences)
Query!
Ethics committee address [1]
310900
0
Research Services | Ground Floor, 16 Wally's Walk Macquarie University, NSW 2109, Australia
Query!
Ethics committee country [1]
310900
0
Australia
Query!
Date submitted for ethics approval [1]
310900
0
16/05/2022
Query!
Approval date [1]
310900
0
01/07/2022
Query!
Ethics approval number [1]
310900
0
520221167539476
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
119278
0
A/Prof Wayne Warburton
Query!
Address
119278
0
4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia
Query!
Country
119278
0
Australia
Query!
Phone
119278
0
+61 2 9850 8643
Query!
Fax
119278
0
Query!
Email
119278
0
[email protected]
Query!
Contact person for public queries
Name
119279
0
Brad Marshall
Query!
Address
119279
0
Brad Marshall
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Query!
Country
119279
0
Australia
Query!
Phone
119279
0
+61 02 8287 1242
Query!
Fax
119279
0
Query!
Email
119279
0
[email protected]
Query!
Contact person for scientific queries
Name
119280
0
Brad Marshall
Query!
Address
119280
0
Brad Marshall
Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065
Query!
Country
119280
0
Australia
Query!
Phone
119280
0
+61 02 8287 1242
Query!
Fax
119280
0
Query!
Email
119280
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
De-identified and reduced data set with groups and key outcomes
Query!
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)
Query!
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.
Query!
Available for what types of analyses?
Any research approved by an Ethics Committee
Query!
How or where can data be obtained?
It will be uploaded to Australian Data Archive (Repository) https://ada.edu.au
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
16019
Other
https://ada.edu.au
Australian Data Archive
16020
Ethical approval
[email protected]
MQ Ethics Approval submitted on 16.05.22 and await...
[
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.
Download to PDF