Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000012572
Ethics application status
Approved
Date submitted
5/12/2023
Date registered
10/01/2024
Date last updated
10/01/2024
Date data sharing statement initially provided
10/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A weekend intervention for families with screen disordered children
Scientific title
Investigating the impact of a weekend intervention for families with screen disordered children on screen addiction symptoms in the children and parental efficacy to manage screen use in the home.
Secondary ID [1] 309916 0
Nil
Universal Trial Number (UTN)
U1111-1293-8268
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
screen dependency disorders 330422 0
Condition category
Condition code
Mental Health 327257 327257 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Personnel and qualifications

The program will be delivered by:

Prof. Wayne Warburton, is a registered psychologist and key developer of the RES@T-A Australia program, which has now run three successful trials in Australia (see ANZCTR number ACTRN12622000994785 ‘Evaluating the effectiveness of the RES@T-A program of resources strengthening training for adolescents with problematic gaming’). Much of the content delivered by Dr Warburton will be based on the RES@T-A program, but condensed into a weekend format. Thus Dr. Warburton is experienced in delivering the content he will provide.

Mr Brad Marshall is a registered psychologist, Director of North Shore Kid Space, and a PhD student (under Dr Warburton) at Macquarie Unievrsity. He is one of Australia’s leading psychologists for child and adolescent screen disorders and has published a successful book for parents of young people with screen disorders. Mr Marshall specialises in delivering content to enable parents of young persons with screen disorders manage the disorder in their house, and is thus experienced in delivering the content he will provide.

Two additional people will provide clinical support:

Dr Kim Le, Psychiatrist, who specialises in screen disorders and works from the CGI clinic in Adelaide and from Australia’s only screen disorder clinic at Fiona Stanley hospital in Perth. Dr Le is a highly regarded as a treating clinician in the field.

Shane Southwood is an intern psychologist, close to registration, who has co-facilitated the RES@T-A Australia program with Dr Warburton for all three offerings and thus has substantial skill in running screen disorder programs for teens (see ANZCTR number ACTRN12622000994785 ‘Evaluating the effectiveness of the RES@T-A program of resources strengthening training for adolescents with problematic gaming’).

Participants.

Up to 8 children and 12 parents can attend

The program

What is in the intervention program?

The intervention will run across three days in a family camp environment. There will be 6 sessions of 1-2 hours each, the sixth session split into two 1 hour sessions. Interspersed will be family activities and free time.

The program is primarily group-based.

The young people will be in one group led by Prof. Warburton, Dr Le and Mr Southwood, and the parents in a group led by Mr Marshall for most sessions, with Prof. Warburton leading a session explaining what the young people have learned and key strategies for maintaining behaviour change. In some sessions both groups will combine. For example, the first session will be primarily an education session that will involve all participants.

It is anticipated that some participants may need to speak to a psychologist/psychiatrist one to one to discuss or clarify parts of the program or to discuss specific issues. This will happen on an as-needed basis, and is the key reason that there will be two other psychologists/psychiatrists available apart from Dr Warburton and Mr Marshall.

To be clear, the one to one sessions will not be individual therapy sessions, but assistance as needed to support those participating in the program, which is the intervention.

The program will involve:

Session 1: combined group session, psychoeducation, both groups

Session 2:
- Young people: mindfulness game, introduce each other, psychoeducation, motivational task around benefits and pitfalls of screen use, task around risks and triggers for problematic use, introduce cycle of addiction.
- Parents: Why young people use screens, what needs screens meet for young people, identifying the role of screen use in your child’s life, finding ways to meet those needs in the offline world, guided small group discussion on meeting needs within the family (more detail below).

Session 3:
- Young people: mindfulness game, task around developing strategies to manage screen use, motivational work around sleep and health, develop sleeping plan, task to investigate offline options to manage stress, anxiety and negative emotions.
- Parents: Screen use strategies within the home 1, guided small group discussions around how to implement these strategies (more detail below).

Session 4:
- Young people: mindfulness game, skill building tasks for emotion management, stress management, relationship and communication skills.
- Parents: Screen use strategies within the home 2, guided small group discussions around how to implement these strategies (more detail below).

Session 6a: Combined session:
Stage 1, Family plan. Saturday night introduce family plan, small group sessions
Family strategies to maintain behaviour change over time and set up patterns of healthy screen use within the family. Each family comes together to develop their own family screen management plan, and their plan to support any child with problematic screen use, under the guidance of the facilitators. [BM to introduce session and guidelines][All facilitators visit families and provide guidance as each family puts together its plan].

Session 5:
- Young people: Mindfulness game, develop personal plan to (a) break cycle of addiction and (b) manage situations with a high risk of leading to problematic screen behaviour and what to do if there are signs that screen use is starting to gain control of the young person again.
- Parents: Key elements of the program that need to be reinforced within the home going forward, so that their children’s new knowledge and skills can be ‘bedded in’ towards long-term behaviour change. Practical strategies across a range of key skills (more detail below).

Session 6b Combined session: Family strategies to maintain behaviour change over time and set up patterns of healthy screen use within the family. Each family comes together to develop their own family screen management plan, and their plan to support any child with problematic screen use, under the guidance of the facilitators.

Specific session content for the young people:

• Psychoeducation sessions about what draws people to screens, persuasive design techniques used by online platforms to keep people at the screen and use neuroscience to encourage addiction-like behaviours, the nature of screen disorders, impacts that screen overuse and screen disorders can have (psychological and physical), ways to develop a healthy media diet and ways to lessen the impact of persuasive design elements in screen media.
• Most or all screen disorded teens are on ‘automatic pilot’ and driven by the limbic system when using a screen. The frontal lobes of the brain, which enables impulse control, emotion management, behaviour management, thinking through of consequences, focus/attention, planning, complex problem solving and other ‘higher executive functions’ is much less active. This puts the screen and pleasure seeking impulses in control, and means the young person has little conscious control over their behaviour. Much of the program is about helping the child regain conscious control of their behaviour, by engaging the front brain and the higher functions. One way we will do this is to do fun mindfulness exercises to engage the conscious brain – group games that require young people to concentrate and use their higher cognitive functions. For example remembering increasingly complex sequences of ball tossing between people, lining up in order according to criteria such as shoe size without verbal communication, or quickly creating multi-person formations when asked.
• Most screen disordered young people underplay their issues and do not want to change, even when they know their screen sue is having substantial negative impacts on their life. Thus we will include motivational tasks designed to help the young person get a sense of whether their screen use is a problem or not, such as providing comparison data about average levels of screen use in trivia style games, getting participants to compile lists of short- and long-term advantages and disadvantages of screen use, and discussing graphs of things like average sleep time for children of their age.
• Skill building tasks. Most young people with screen disorders have difficulty regulating emotions and managing stress. Most develop a problem because their ‘go to’ response to feeling stressed or having a negative emotion is to use a screen, which makes them feel better. This becomes an frequently repeated response that eventually sets up a ‘cycle of addiction’ that starts with feeling stressed or anxious or sad or angry. To help provide strategies to break this cycle we will include:
o An explanation of the cycle of addiction
o An emotion regulation task and information about healthy emotion regulation
o An activity for developing a range of responses to stress at high, moderate and low levels
o An activity designed to get young people think about alternate offline activities that they can undertake when feeling stressed, anxious, bored, sad angry etc., in a variety of situations
o An activity designed to help young people develop self-control strategies that will help them manage their screen use.
• Many screen disordered young people have issues with social isolation, social skills, and offline friendships. We will have an activity designed to build relationships skills and increase coinfidence in establishing offline friendships.
• Young people will build a specific plan that identifies factors which put them at greater risk of losing control of their screen use, indicators that they are losing control of their screen use, and specific strategies to reduce risk or get back on track where there are indicators.
• Together, these tasks, activities and learnings should help the young person to gain greater cognitive control of their behaviour and break the cycle of addiction in a number of places.
• Young people will put together a folder with all the key resources that they can keep and refer to later.
• Material, tasks and activities will be drawn from the RES@T-A Australia program (see www.resataus.com.au for more details).

Specific session content for the parents:

Parents will be given talks and then discuss various issues within groups. Topics will include:

• Psychoeducation sessions about what draws people to screens, persuasive design techniques used by online platforms to keep people at the screen and use neuroscience to encourage addiction-like behaviours, the nature of screen disorders, impacts that screen overuse and screen disorders can have (psychological and physical), ways to develop a healthy media diet and ways to lessen the impact of persuasive design elements in screen media.
• Strategies for managing screen use in the home. These include:
o technological approaches such as controlling the wifi and internet, changing a range of settings on devices, the types of data plans young people should have, appropriate devices at appropriate ages
o setting up a family media plan and family media rules, and strategies around setting and adhering to consequences for breaking those rules
o helpful and unhelpful ways of working with the young people in terms of their screen disorder and screen behaviour, and managing conflict
o managing aggressive and violent behaviour
o establishing what needs their screen use meets and how to meet those needs in the offline world.
o How addictions and behavioru patterns are set and ways to break those patterns
o More details of this program material is in the uploaded Parent treatment manual.
• Parents will also be given the key messages their children are being given in the other room, and strategies for supporting the new skills and knowledge and behaviour change strategies their children are developing in day to day life in the home. This includes;
o Revising the notes that children will be given, and notes that they will be given,
o Encouraging conscious, mindful awareness, higher executve functions as noted in the previous section, consciously living in the moment, using the five senses and emotional awareness;
o Encouraging the emotion regulation strategies learned;
o Encouraging the stress management strategies learned;
o Supporting and facilitating the plan their children have made to better manage their screen use;
o Being aware of the cycle of addiction and the places it can be broken;
o Encouraging offline friendships and interpersonal communication skills learned;
o Encouraging their child to build a repertoire of offline activities, interests and skills.
• Parents will be given a handout detailing many of the above, that they can refer to later.

Other activities
• There will also be a range of fun activities such as archery, canoeing or bushwalking etc. to facilitate re-engagement with the offline world. These cannot be finalised at this stage as the specific activities will depend on the venue that can be secured, and this will depend on the number and timing of participant enrolments.
• Being in community – all participants and personnel eating and socialising together to create an atmosphere of connection and mutual support.

Participant materials

Participants will build a folder of hard copy materials from each of the sessions across the course of the weekend, one for each child, and one for each child’s parent(s). These can be used as a resource post-program.

Adherence measures

The attendance for each participant will be noted session by session, for both parents and the children. Attendance at weekend activities will also be documented.

Intervention code [1] 327556 0
Treatment: Other
Intervention code [2] 327633 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336763 0
Gaming Disorder Symptoms - Internet Gaming Disorder diagnostic criteria as evidenced by a score of 5 or more on the IGDT-10 child self report'
IGD-10 (internet gaming disorder 10-item measure)
Kiraly et al 2017
Timepoint [1] 336763 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Primary outcome [2] 336764 0
Social Media Disorder
Burgen Social Media Addiction Scale (BSMAS)
Andreasson et al 2017
Timepoint [2] 336764 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Primary outcome [3] 336765 0
Phone addiction
Smartphone Application-Based Addiction Scale (SABAS)
Csibi et al 2018
Timepoint [3] 336765 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [1] 429614 0
Attachment and connectedness between child and parents
Parent Family Connectedness Scale (child report)
Warburton et al (2022)
Timepoint [1] 429614 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [2] 429615 0
Child report of average weekday screen time on computer, tablet/laptop, games console, television and smart phone;
Child report of average weekend screen time on computer, tablet/laptop, games console, television and smart phone.
Timepoint [2] 429615 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Note t2 data may not be used given child's restricted access to screens during the program
Secondary outcome [3] 429616 0
Impact of screen disorder on developmental domains
Developmental Impacts Questionnaire - parent report
Marshall et al 2022
Timepoint [3] 429616 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [4] 429617 0
Child's strengths and struggles
Strengths and Difficulties Questionnaire (SDQ) (Parent report on child’s strengths and areas of where they may struggle).
Goodman, 1997
Timepoint [4] 429617 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [5] 429618 0
Child's aggression
Child's Aggressiveness Scale
Warburton, 2022
Timepoint [5] 429618 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [6] 429619 0
Self efficacy around screens
Purpose built measure, 5 items
Timepoint [6] 429619 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [7] 429620 0
Emotion regulation
Purpose built measure
7 items
Timepoint [7] 429620 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [8] 429621 0
Focus, attention, executive function, thinking fast and slow
18 items, purpose built
Items added to create overall executive function measure (composite outcome)
Timepoint [8] 429621 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [9] 429622 0
Stress management
4 items, purpose built
Timepoint [9] 429622 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [10] 429623 0
Relationship skills
5 items purpose built
Timepoint [10] 429623 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [11] 429624 0
Engagement with the offline world
4 items purpose built
Timepoint [11] 429624 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [12] 429625 0
Understanding of screen problems
11 items purpose built
Timepoint [12] 429625 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [13] 430011 0
Primary Outcome
Gaming Disorder Symptoms - Internet Gaming Disorder diagnostic criteria as evidenced by a score of 5 or more on the IGDT-10, parent report.
IGD-10 (internet gaming disorder 10-item measure)
Kiraly et al 2017
Timepoint [13] 430011 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [14] 430013 0
Attachment and connectedness between child and parents
Child-parent relationship scale (parent report)
Pianta (1992)
Timepoint [14] 430013 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [15] 430014 0
Parent report of child’s average weekday screen time on computer, tablet/laptop, games console, television and smart phone;
Parent report of child’s average weekend screen time on computer, tablet/laptop, games console, television and smart phone.
Timepoint [15] 430014 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Note t2 data may not be used given child's restricted access to screens during the program
Secondary outcome [16] 430015 0
Strategies for managing screen use in the home
Parent report
7 item purpose built scale
Timepoint [16] 430015 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [17] 430016 0
Family engagement with the offline world
Parent report
5-item purpose built scale
Timepoint [17] 430016 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [18] 430017 0
Parent's understanding of screen use problems
Parent report
11-item purpose built measure
Timepoint [18] 430017 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program
Secondary outcome [19] 430018 0
Impact of screen disorder on developmental domains
Developmental Impacts Questionnaire - child report
Marshall et al 2022
Timepoint [19] 430018 0
t1 baseline, pre program
t2 immediately post-program
t3 3 months post program

Eligibility
Key inclusion criteria
- The attending young people in the family aged 10 or older and at school;
- No attending family member can have a serious mental health condition such as an illness with a psychosis component like schizophrenia.
- No attending child should have another addiction including problem gambling
- Attending children on the Autism spectrum must be high functioning, going to a regular school, able to manage a group environment and the cognitive load of several group sessions, and to be assessed as having no identifiable risk of harm from participating in such a program.
- All participants must be physically able to participate together in outdoor activities such as bushwalking, canoeing, and other such activities
- Any other issue that staff believe would cause the attending person to be at risk from, or not to benefit from, the program.
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- A potential attending young person who is aged below 10 or has finished school;
- A potential attending family member that has a serious mental health condition such as an illness with a psychosis component like schizophrenia.
- A potential attending child that has another addiction including problem gambling
- A potential attending child on the Autism spectrum who is NOT all of the below: high functioning, going to a regular school, able to manage a group environment and the cognitive load of several group sessions, and assessed as having no identifiable risk of harm from participating in such a program.
- People who are NOT physically able to participate together in outdoor activities such as bushwalking, canoeing, and other such activities
- People with any other issue that staff believe would cause the attending person to be at risk from, or not to benefit from, the 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?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measures ANOVA to assess efficacy and retention of program across time and across outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/11/2023
Date of last participant enrolment
Anticipated
18/01/2024
Actual
Date of last data collection
Anticipated
22/04/2024
Actual
Sample size
Target
10
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 314099 0
Commercial sector/Industry
Name [1] 314099 0
Channel 7, Sydney
Country [1] 314099 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University, Sydney, NSW, 2109, Australia
Country
Australia
Secondary sponsor category [1] 316016 0
Commercial sector/Industry
Name [1] 316016 0
Channel 7
Address [1] 316016 0
Channel 7, 52 Martin Place - Sydney, NSW, Australia
Country [1] 316016 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313238 0
Macquarie University Human Research Ethics Committee - Medical
Ethics committee address [1] 313238 0
Macquarie University, Sydney, NSW, 2109, Australia
Ethics committee country [1] 313238 0
Australia
Date submitted for ethics approval [1] 313238 0
19/06/2023
Approval date [1] 313238 0
17/08/2023
Ethics approval number [1] 313238 0
Reference No:520231571552485

Summary
Brief summary
Approval was granted to run trials of a 3 day weekend intervention for children and parents in families where one child is screen disordered. This application was carefully scrutinised by the HREC, a separate meeting was organised to discuss more sensitive issues, and all ethical aspects were carefully addressed to HREC satisfaction before final approval was given. The trial will be run through Macquarie University, and the first trial will be filmed and paid for by Channel 7 for their Spotlight program. Prospective participants are given two information and consent forms - one from Macquarie and one from Channel 7 - and will speak to Channel 7 at length before making a decision to apply to participate, as we believe it is crucial participants are fully informed about the implications of the trial being televised before agreeing to participate. Final vetting of applications are by Prof Warburton and Mr Marshall, with the key criterion being no reasonably identifiable indication of potential harm to participants and an assessed likelihood that the child will benefit from the program.. Participants are fully informed and not coerced in any way to participate. Prof Warburton and Mr Marshall are not paid to create or run the program and have no conflicts of interest.
It is hypothesised that child participants in the intervention will show reduced screen disorder symptoms and greater insight into their screen use immediately after the intervention, with continued benefits at 3 months after the program. It is also hypothesised that parents will report feeling more able to manage screen use issues in the home post intervention and will report improvements in their child's screen habits and symptoms 3 months after the program.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 127442 0
Prof Wayne Warburton
Address 127442 0
School of psychological sciences, Macquarie University Wallumattagal Campus Macquarie Park NSW 2109
Country 127442 0
Australia
Phone 127442 0
+61 2 9850 8643
Fax 127442 0
Email 127442 0
wayne.warburton@mq.edu.au
Contact person for public queries
Name 127443 0
Prof Wayne Warburton
Address 127443 0
School of psychological sciences, Macquarie University Wallumattagal Campus Macquarie Park NSW 2109
Country 127443 0
Australia
Phone 127443 0
+61 2 9850 8643
Fax 127443 0
Email 127443 0
wayne.warburton@mq.edu.au
Contact person for scientific queries
Name 127444 0
Prof Wayne Warburton
Address 127444 0
School of psychological sciences, Macquarie University Wallumattagal Campus Macquarie Park NSW 2109
Country 127444 0
Australia
Phone 127444 0
+61 2 9850 8643
Fax 127444 0
Email 127444 0
wayne.warburton@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 individual participant data used in published results will be available through Australian data archives
When will data be available (start and end dates)?
IPD data used in published results will be made available at the time of publication and will remain available for 7 years.
Available to whom?
Available on application to ADA to those with HREC approval to use the data
Available for what types of analyses?
Unsure. We will do RM ANOVAs but others may want to analyse data differently.
How or where can data be obtained?
Available on application to ADA to those with HREC approval to use the data, via the ADA data access portal at https://ada.edu.au/accessing-data/.


What supporting documents are/will be available?

No Supporting Document Provided



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.