ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622001353785

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

Parenting and behavioural strategies for for Screen and Gaming Addiction in children and teens

Scientific title

Parent Treatment Intervention for Screens and Gaming Disorder: Evaluating the impact on screen time and developmental impacts on children.

Secondary ID [1]

Universal Trial Number (UTN)

U1111-1283-9886

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Gaming Disorder

Hazardous Gaming

Internet Gaming Disorder

Problematic Screen Use

Condition category

Condition code

Mental Health

Addiction

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Parents attending a 90 minute parent seminar at their local school will be invited to participate (opt-in) to the proposed study. The seminar will provide psycho-education on screens and gaming as well as parent strategies to manage this in the family. The session is delivered by a registered psychologist and expert in the field from the Screens & Gaming Disorder Clinic. If they elect to opt in they will be given a link or QR code to complete the pre-treatment survey before the parent seminar takes place.

Those parents who participate will receive free 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. All modules are available immediately, with access granted from the first time the parent logs onto the website. 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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

Control group will consist of those participants who agree to participate but 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]

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 per day

Timepoint [1]

1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up

Primary outcome [2]

Impact on child developmental domains (emotional wellbeing, social, physical health, behaviour and education) as measured by a Screens and Developmental Impact Questionnaire

Timepoint [2]

1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up

Primary outcome [3]

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]

1. Pre- Treatment (before watching video modules)
2. Post- Treatment (six week) follow up

Secondary outcome [1]

Level of Sleep Disturbance as measured by the Sleep Disturbances Scale for Children

Timepoint [1]

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 their voluntary attendance at a school parent seminar. 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

28/10/2022

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]

2065 - Greenwich

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Address [1]

Country [1]

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]

Other

Name [1]

Screens and Gaming Disorder Clinic

Address [1]

20/130-134 Pacific Highway
Greenwich
NSW 2065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee (Humanities and Social Science)

Ethics committee address [1]

Research Services | Ground Floor, 16 Wally's Walk
Macquarie University, NSW 2109, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/07/2020

Approval date [1]

04/09/2020

Ethics approval number [1]

52020790719088

Summary

Brief summary

This study aims to provide understanding of parenting interventions for IGD by providing such an intervention and then testing its effect using a range of measures around the child’s functioning and wellbeing pre- during- and post intervention. The current study will also provide specific data on an Australian population, and examine possible cultural differences in such interventions. In addition, given the rapid advances in technology over the last 5-10 years (smartphone capabilities, devices in schools, faster internet speeds, new video game development etc), this study would provide clarity around the efficacy of assisting parents with technical advice around managing screen and internet access. Finally, whilst physical monitoring of screen time is a common strategy for parents of younger children, it becomes untenable and combative when applied in adolescents. This study will emphasise a model of monitoring internet access as opposed to screen access, and to our knowledge this key differentiation has not been explored to date.

Hypotheses:
1. That parents who are able to implement the model for 6 weeks post intervention, compared to those parents who didn’t implement the strategies, will report a decrease in child screen use and an overall increase 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 problematic screen-use prior to intervention will report an initial increase in family conflict followed by a steady reduction once the parent strategies are in place.

Trial website

Trial related presentations / publications

Public notes

NA

Contacts

Principal investigator

Name

A/Prof Wayne Warburton

Address

4 First Walk
(C3A) Building, Room 408
Macquarie University, NSW 2109, Australia

Country

Australia

Phone

+61 2 98508643

Fax

wayne.warburton@mq.edu.au

Contact person for public queries

Name

Brad Marshall

Address

Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065

Country

Australia

Phone

+61 2 82871242

Fax

bradley.marshall@hdr.mq.edu.au

Contact person for scientific queries

Name

Brad Marshall

Address

Screens & Gaming Disorder Clinic
20/130-134 Pacific Highway
Greenwich
NSW 2065

Country

Australia

Phone

+61 2 82871242

Fax

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.	Type	Citation	Link	Email	Other Details	Attachment
17358	Ethical approval			Wayne.warburton@mq.edu.au
17359	Other	Australian Data Archive	https://ada.edu.au/		Meta Data records along with the de-identified dat... [More Details]

Results publications and other study-related documents

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Documents added automatically

No additional documents have been identified.

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