Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000994785
Ethics application status
Approved
Date submitted
23/06/2022
Date registered
14/07/2022
Date last updated
29/09/2022
Date data sharing statement initially provided
14/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of the RES@T-A program of resources strengthening training for adolescents with problematic gaming
Scientific title
Evaluating the effectiveness of the RES@T-A program of resources strengthening training for adolescents with problematic gaming
Secondary ID [1] 307423 0
None
Universal Trial Number (UTN)
U1111-1278-5481
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Problematic Video Game Use 326767 0
Internet Gaming Disorder 326769 0
Gaming Disorder 326770 0
Hazardous Gaming 326771 0
Condition category
Condition code
Mental Health 323993 323993 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In total there are 13 sessions, all conducted in-person.
- 3 individual sessions, 1-2½ hours, including testing
- 9 group sessions with program content (2 hours). Groups have up to 16 participants.
- 1 testing session to evaluate the retention of gains made in the program (1-1½ hours)

These occur across a 5 month period, with the first 11 sessions occurring, roughly, in consecutive weeks. The final 2 sessions occur about 4 and 12 weeks after that. In addition, those in later offerings of the program also need to do pre-program, post-program and retention testing at the same time as the first offering, to gather comparison data.

Groups sessions include psychoeducation via facilitator, flipcharts, powerpoint presentations and watching videos; motivational interviewing techniques; CBT techniques; working through a series of worksheets; discussing homework (self-recorded observations); and informal discussion. All materials are purpose created for this program.

Adherence to the program is assessed via assessment of self-recorded observations and self-recording of tasks, performed at home. This is done both in groups and in individual sessions (where adherence is assessed and discussed in greater detail).

The program has five stages.

Stage 1. Come in, stay in.

Initial session. This is an individual session involving the teenager, a parent or parents and some RES@T team members. This will occur in the fortnight before the first program group session, at a time agreed between the parent and the RES@T team. In this session:
- The teenager and parent(s) will be introduced to the program and will discuss that teenagers specific situation and needs;
- The teenager will be given a unique ID that will allow us to match data from different time points in the program, but in a way that makes that teenager unidentifiable in the main data set;
- The parent and teenager will each complete some online questionnaires while they are at the session;
- The teenager will undertake some cognitive function tests.
- At the completion of the session both the teenager and the parent will receive a $20 gift card.

Stage 2: Psychoeducation. Gain insight, get bright

Group sessions for teenagers
Program session 1: Participants get to know each other and discuss their own situations. Teams are formed and various games are played. Statistics and facts about problematic gaming are provided to help participants better understand the problem and to know that they aren’t alone in having a problem with video games. Participants reflect on when gaming wasn’t a problem for them and then set goals for the program.

Program session 2: In this session participants reflect on their own gaming behaviour, learn about what can cause problematic and disordered gaming, explore motivations to change gaming behaviour, and start to create their own explanation for why gaming has become a problem for them.

Stage 3: Clever clogs instead of underdogs

Group sessions for teenagers
Program session 3: Eat, sleep, exercise, repeat. In this session participants learn how gaming impacts a healthy lifestyle and how a healthy lifestyle, including sufficient sleep, can help them manage their gaming better. Participants reflect on how their gaming has impacted their sleep and daily routines.

Program session 4: Self care for confidence. In this session participants learn about self care and regulating self-esteem. They explore their talents and strengths, and use a decision-making tool to identify offline areas of strength, and offline activities they would enjoy or like to develop.

The mid program review: This is an individual session involving the teenager, a parent or parents and some RES@T team members, that occurs in the week following program session 4. Individual feedback is given on the teenager’s progress and their training plan is evaluated. Any issues are discussed.

Stage 4: Relation and connection

Group sessions for teenagers
Program session 5: The circuit of emotions. The teenagers will learn about the functions their emotions have, and about functional and dysfunctional emotion regulation. Participants reflect on the roles their emotions play during game play and about their own style of managing emotions, and create a list of strategies to use when under stress.

Program session 6: Social relationships. Participants reflect on the advantages and disadvantages of face-to-face versus online relationships, and the need for F2F relationships is discussed. Participants create their own social network as a basis for potential offline relationships and learn important communication and relationship skills.

Program session 7: Communication skills. Participants learn to differentiate between verbal and physical communication, and between communication that is validating versus invalidating. Participants learn about (cyber-)mobbing and rules of respectful interactions.

Stage 5: Keeping the strength

Group session for teenagers
Program session 8: Relapse prevention. Participants learn about addiction memory and the concept of craving. They receive an anti-relapse plan and create a list of possibly risky situations that could lead back to problematic gaming. They add to the relapse plan problematic behaviours that could lead to a returning to old habits. Self-control strategies are also discussed. Training plans are evaluated and the winning team is announced.

Post-Program session: This is an individual session involving the teenager, a parent or parents and some RES@T team members that occurs in the fortnight following program session 8.
- Individual feedback will be given on the teenager’s progress
- The emergency plan will be revised/updated as needed
- The parent and teenager will each complete some online questionnaires;
- The teenager will undertake some cognitive function tests.
- At the completion of the session both the teenager and the parent will receive a $20 gift card.

Group session for teenagers
Program session 9: Booster session. In this session, which is run about 4 weeks after Program session 8, there is an open group discussion, participants reflect on their progress, and the team offer assistance in maintaining healthy game use.

Retention testing: This is an individual session involving the teenager, a parent or parents and some RES@T team members that occurs about 8 weeks after the booster session. This is where we collect the final data that will help us understand whether the teenager has retained gains made during they program.
- The parent and teenager will each complete some online questionnaires;
- The teenager will undertake some cognitive function tests.
- At the completion of the session both the teenager and the parent will receive a $20 gift card.
Intervention code [1] 323861 0
Behaviour
Comparator / control treatment
There are two control mechanisms.

1. Those attending later offerings of the program, the 'Treatment as usual' group, will provide control data at the same time as the participants in the first treatment offering. Data will be statistically split so that analyses of control v treatment data is split 50/50 among the 48 participants. This group will not undertake the intervention but will continue with treatment as usual.

Treatment as usual is not defined and is not based on set guidelines - for the purposes of the study it is the participant continuing whatever treatment options they would have been undertaking in any case. It should be noted that the researchers will note down any existing treatments undertaken during the interval between enrolment and participation in the metadata notes for each participant.
2. To gain rare data comparing cognitive function of screen disordered versus normal teenagers, a second normal control group of age and gender matched teenagers (N=48) will be recruited to provide comparison cross-sectional data on cognitive function.

This group will undertake only cognitive testing, and will not participate in the program.
Control group
Active

Outcomes
Primary outcome [1] 331791 0
Disordered Screen use
Gaming Disorder diagnostic criteria using GADIS-A Paschke et al 2020, with minor grammatical revisions for English version.

Timepoint [1] 331791 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Primary outcome [2] 331983 0
2. Internet Gaming Disorder diagnostic criteria as evidenced by a score of 5 or more on the IGDT-10, Kiraly et al 2017 (both a child self report and a parent report version are used).
Timepoint [2] 331983 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [1] 411126 0
Executive function: Delis Kaplan Executive Function System (D-KEFS)
Timepoint [1] 411126 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [2] 411128 0
Abstract concept formation/Executive function: Booklet Category Test
Timepoint [2] 411128 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [3] 411129 0
Frontal lobe function/Executive function: Wisconsin Card Sorting Task
Timepoint [3] 411129 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [4] 411130 0
Selective attention: Ruff 2 & 7 Selective Attention Test
Timepoint [4] 411130 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [5] 411131 0
IQ including various cognitive functions/executive functions: WAIS-IV/WISC-V
Timepoint [5] 411131 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [6] 411132 0
Self efficacy (child report): General Self Efficacy Scale, Schwarzer and Jerusalem, 1995
Timepoint [6] 411132 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [7] 411133 0
Social media addiction (Two versions used: child report and parent report): Burgen Social Media Addiction Scale,. Andreasson et al 2017
Timepoint [7] 411133 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [8] 411134 0
Smart phone addiction (Two versions used: child report and parent report): Smartphone Application-Based Addiction Scale (SABAS), Csibi et al 2017
Timepoint [8] 411134 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [9] 411135 0
Emotion dysregulation (child report): Emotion Dysregulation Questionnaire (reduced form). Original scale by Gill et al., 2020.
Timepoint [9] 411135 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [10] 411136 0
Perceived stress (child report): Perceived Stress Scale, Cohen et al ., 1983
Timepoint [10] 411136 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [11] 411138 0
Sleep quality (child report): Pittsburgh Sleep Quality Index, Buysse et al., 1989
Timepoint [11] 411138 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [12] 411139 0
Daytime sleepiness (child report): Pediatric Daytime Sleepiness Scale, Drake et al., 2003
Timepoint [12] 411139 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [13] 411140 0
Family function/attachment (child report): Parent-family Connectedness Scale - Pianta, 1992 as amended by Warburton et al 2022
Timepoint [13] 411140 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [14] 411141 0
Screen time per week (Two versions used: child report and parent report): Childs weekly screen time - measure based on past measures by Saunders et al., 2016, Gingold et al 2014 and King et al., 2017.
Timepoint [14] 411141 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [15] 411143 0
Developmental impacts of screen use (Two versions used: child report and parent report): Screen Developmental Impact Questionnaire. Developed by Marshall and Warburton, 2021
Timepoint [15] 411143 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [16] 411144 0
Physical health (child report): Participants indicate whether they feel pain in back, neck and wrists using body diagram; Participants note whether the have symptoms of eye strain; Participants report on exercise habits and BMI.
Timepoint [16] 411144 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [17] 411146 0
Socioemotional function (parent report): Strengths and Difficulties Questionnaire 11-17 years, Goodman et al., 1997, 1998, 2001
Timepoint [17] 411146 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [18] 411148 0
Attachment relationship (parent report): Child Parent Relationship Scale, Pianta, 1992.
Timepoint [18] 411148 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [19] 411149 0
Child's mental health (parent report): Revised Children's Anxiety and Depression Scale, Chorpita et al., 2000
Timepoint [19] 411149 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [20] 411150 0
Impact of screen use on sleep (parent report): Sleep Disturbance Scale for Children, Bruni et al., 1996
Timepoint [20] 411150 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion
Secondary outcome [21] 411151 0
Child's aggressiveness (parent report): Purpose built measure for this study.
Timepoint [21] 411151 0
t1 baseline
T2 after program session 8
T3 retention at 3 months post-program completion

Eligibility
Key inclusion criteria
- Participants must be high school students;
Minimum age
12 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For ethical reasons, participants cannot have one of the following conditions:
o Bipolar Disorder, Schizophrenia, or another illness with symptoms of psychosis;
o Another addiction including problem gambling.
Applicants with Autism Spectrum Disorder will be assessed on a case by case basis

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealed - allocation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) randomly allocates participants to one of 3 groups (Offering 1, Offering 2 and Offering 3).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cross sectional analyses of cognitive function data: 48 healthy controls are compared to the 48 participants with problematic screen use.
Trial evaluation between subjects: Clinical outcome data is compared to data from Treatment as usual controls at same time points, with participants split into groups of 24
Trial evaluation within subjects. Outcomes are compared at time 1 (baseline), time 2 (after the program week 8) and time 3 (retention 3 months post program).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cross sectional analyses of cognitive function data: 48 healthy controls are compared to the 48 participants with problematic screen use.
Trial evaluation between subjects: Clinical outcome data is compared to data from Treatment as usual controls at same time points, with participants split into groups of 24
Trial evaluation within subjects. Outcomes are compared at time 1 (baseline), time 2 (after the program week 8) and time 3 (retention 3 months post program).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/09/2022
Actual
Date of last participant enrolment
Anticipated
3/04/2023
Actual
Date of last data collection
Anticipated
16/08/2023
Actual
Sample size
Target
96
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311698 0
University
Name [1] 311698 0
Hamburg University
Country [1] 311698 0
Germany
Primary sponsor type
University
Name
Macquarie University
Address
Sydney, NSW, 2109
Country
Australia
Secondary sponsor category [1] 313155 0
None
Name [1] 313155 0
Address [1] 313155 0
Country [1] 313155 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311151 0
Macquarie University Human Ethics Review Committee; Medical Sciences
Ethics committee address [1] 311151 0
Ethics committee country [1] 311151 0
Australia
Date submitted for ethics approval [1] 311151 0
15/07/2022
Approval date [1] 311151 0
26/08/2022
Ethics approval number [1] 311151 0
Reference No:520221183741462

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

Contacts
Principal investigator
Name 120122 0
A/Prof Wayne Warburton
Address 120122 0
Macquarie University, Sydney, NSW, 2019
Country 120122 0
Australia
Phone 120122 0
+61 2 9850 8643
Fax 120122 0
Email 120122 0
[email protected]
Contact person for public queries
Name 120123 0
Wayne Warburton
Address 120123 0
Macquarie University, Sydney, NSW, 2109
Country 120123 0
Australia
Phone 120123 0
+61 2 9850 8643
Fax 120123 0
Email 120123 0
[email protected]
Contact person for scientific queries
Name 120124 0
Wayne Warburton
Address 120124 0
Macquarie University, Sydney, NSW, 2019
Country 120124 0
Australia
Phone 120124 0
+61 2 9850 8643
Fax 120124 0
Email 120124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is highly sensitive data that cannot be shared. All publicly available data will be de-identified and curated at the Australian Data Archives.


What supporting documents are/will be available?




Results publications and other study-related documents

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Documents added automatically
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