Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000763640
Ethics application status
Approved
Date submitted
8/06/2023
Date registered
12/07/2023
Date last updated
12/07/2023
Date data sharing statement initially provided
12/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Restricting Access to Mobile Phones in Secondary Schools: The RAMP Intervention.
Scientific title
The Effects of Restricting Access to Mobile Phones in Secondary Schools on Physical Activity and Health Outcomes: The RAMP Randomised Controlled Trial.
Secondary ID [1] 309867 0
Nil known
Universal Trial Number (UTN)
Trial acronym
RAMP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 330308 0
Problematic phone use 330310 0
Psychological wellbeing 330311 0
Behavioural functioning 330313 0
Cyberbullying 330314 0
Executive function 330315 0
Condition category
Condition code
Public Health 327170 327170 0 0
Health promotion/education
Mental Health 327285 327285 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A parallel-group cluster randomised controlled trial (RCT) will be conducted in ten secondary schools located across New South Wales (NSW), Australia. The intervention will last for approximately 3 months and will involve measurement at baseline, approximately 3- and 12-month post-baseline (long-term follow-up). This study will recruit students (years 7-12), teachers and parents/carers.

The intervention will consist of:
1. The introduction of a school-level policy to restrict access to mobile phones for students during school hours. Schools will develop a school-level mobile phone policy and support the development of an implementation approach for the policy. An implementation approach that is suitable to the school will be selected by the Principal based on methods commonly used by secondary schools that have previously implemented such policies. Implementation methods may vary based on schools’ preferences and may include:
• The introduction of lockable mobile phone pouches upon entry to the school,
• Requiring mobile phones be placed in school bags and in class mobile phone boxes during school hours.

The research team will work with schools to support the implementation of the policy and provide additional support if such assistance is required/requested (e.g. ongoing implementation support, meetings with the staff, and help in developing a smartphone restriction policy). At the end of the school day, students will be able to unlock their devices upon leaving school or remove phones from school bags/in-class boxes.

2. A short education session, in the form of a five-minute video, outlining the rationale, context, and evidence for reducing access to mobile phones during school hours.
In addition to the above, we will also make available for schools interested, an educational video that could be implemented with all teachers (via an existing staff meeting), students (during PDHE lessons), and parents/carers (via existing digital communication channels).

Adherence will be monitored during school-based observations and during support meetings with the schools through the key contact person.
Intervention code [1] 326292 0
Lifestyle
Comparator / control treatment
For the duration of the study, control schools will be asked to continue allowing mobile phone use as usual for the duration of the study until first follow-up (approx. 3 months).
Control group
Active

Outcomes
Primary outcome [1] 335045 0
Student physical activity (observational assessment).
Physical activity among students will be assessed using the validated System for Observing Play and Leisure Activity in Youth (SOPLAY) observational assessment tool during recess and lunch breaks. The tool is based on momentary time sampling techniques in which systematic and periodic scans of individuals and contextual factors within pre-determined target areas are made.
Timepoint [1] 335045 0
Students will be assessed at baseline assessment, 3-month and 12-month follow-up.
Secondary outcome [1] 422838 0
Student’s smartphone use.
Smartphone use will be assessed using modified items around students’ smartphone use from the student and parents’ perspectives. The items will focus on smartphone use duration (before, during, and after school), and time spent on various activities (e.g., social media, watching videos). The items were created specifically for this study.
Timepoint [1] 422838 0
Students will be assessed at baseline assessment, 3-month and 12-month follow-up.
Secondary outcome [2] 422839 0
Problematic phone use.
Problematic phone use among students will be measured using the Smartphone Addiction Scale Short Version (SAS-SV), that contains 10 items. The items will be related to the following symptoms of problematic smartphone use: loss of control, disruption, disregard, withdrawal, preoccupation, and tolerance. Items are scored on a six-point Likert scale of 1 (strongly disagree) to 6 (strongly agree).
Timepoint [2] 422839 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [3] 422840 0
Behavioural functioning.
The behavioural functioning measure will be assessed via Strengths and Difficulties Questionnaire (SDQ) in relation to emotional symptoms, conducting problems, hyperactivity/inattention, peer relationship problems and prosocial behaviour. Students will complete the 25-item SDQ via an online survey completed in during school hours, within schools at baseline and again at 3-month and 12-month.
Timepoint [3] 422840 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [4] 422841 0
Psychological wellbeing.
Student’s psychological wellbeing will be assessed by Warwick-Edinburgh Mental Well-being Scale. The 7-item questionnaire requires participants to reflect on their experiences over the last 2 weeks. Items are scored on a five-point scale ranging from 1 ‘None of the time’ to 5 ‘All of the time’ and summed across all to produce a well-being composite.
Timepoint [4] 422841 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [5] 422842 0
Social Connectedness.
Social interaction among students will be assessed using Social Connectedness Scale, an eight-item measure. Items are scored on a four-point Likert scale (from strongly disagree to strongly agree).
Timepoint [5] 422842 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [6] 422843 0
Executive function.
Executive functions around attention, self-monitoring and planning and initiative will be assessed using the Amsterdam Executive Function Inventory (AEFI). AEFI is a brief self-report (13-items) questionnaire.
Timepoint [6] 422843 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [7] 422844 0
Bulling at school.
Bulling at school frequency will be assessed adopting one-item from the Olweus Bully measure. (Victim Questionnaire) : “How often have you been bullied at school (in person) in the past couple of months?”.
Timepoint [7] 422844 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [8] 422845 0
Cyberbullying.
The cyber-victimisation among students will be assessed using the European Cyberbullying Intervention Project Questionnaire (ECIPQ). The questionnaire consists of 11-items and that are scored on a five-point Likert type scale ranging from 0 never to more, 1 once or twice, 2 once a month, 3 once a week, 4 more times a week.
Timepoint [8] 422845 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [9] 422846 0
Assessment of students’ behaviour in the classroom and playground.
The research team developed six-items that will assess teachers’ perception of students' focus, distraction, and engagement since the implementation of the study intervention. The answers will be recorded on the five-point Likert scale from completely disagree to completely agree. The items examples: ‘Students’ focus in the classroom improved activities since the phone restriction policy at my school’, ‘Students are less distracted in class since the introduction of phone restriction policy at my school’. This will be assessed as a composite outcome.
Timepoint [9] 422846 0
Teachers will be assessed at baseline assessment, 3-month and 12-month follow-up.
Secondary outcome [10] 422847 0
Self-reported physical activity.
Self-reported physical activity will be measured using one-item measure from the Cancer Councils’ National Secondary Students' Diet and Activity (NaSSDA) survey. Students will be asked: “Over the past 7 days, on how many days were you physically active for a total of 60 min or more per day?”.
Timepoint [10] 422847 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [11] 422849 0
Sedentary behaviour and screen time.
Sedentary behaviour and screen time will be assessed using modified two-items that ask about the weekday and weekend activities. Adolescents will be asked to indicate how much time during a typical weekday and weekend day they spent in seven sedentary behaviours outside school hours (‘On a typical weekday, how much time do you spend on the following behaviours?’, ‘On a typical weekend how much time do you spend on the following behaviours?’). The sedentary behaviours include watching TV, watching videos; playing sedentary computer or video games;using the internet, emailing or other electronic media for leisure (e.g., Facebook, Instagram); doing homework (including reading, writing, or using the computer). This will be assessed as a composite outcome.
Timepoint [11] 422849 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [12] 422850 0
In class on-task behaviour (observational assessment).
On-task measure will be assessed using Behavioural Observations of Students at Schools (BOSS) measure. This observational assessment tool will be conducted during classes at baseline assessments, immediately post-intervention and during 12-month follow-up. The BOSS measure divides on-task behaviour into active engaged time (AET; coded when a student is actively engaged in academic responding, e.g., reading aloud, writing in a journal), and passive engaged time (PET; coded when a student is passively attending., listening to a teacher, looking at the black-board while a teacher writes). Both AET and PET are scored using momentary time sampling at the beginning of each 15-second interval. This will be assessed as a composite outcome.
Timepoint [12] 422850 0
Students will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Secondary outcome [13] 423413 0
Acceptability of the program. Acceptability of the intervention will be assessed by the students, parents and teachers using the one-item developed by the research team.
Timepoint [13] 423413 0
Students and teachers will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Parents will be assessed at 3-month follow-up and 12-month follow-up.
Secondary outcome [14] 423414 0
Appropriateness of the program. Teachers and parents will be asked about intervention appropriateness; one item developed by the research team.
Timepoint [14] 423414 0
Teachers will be assessed at baseline assessment, 3-month, and 12-month follow-up.
Parents will be assessed at 3-month and 12-month follow-up.
Secondary outcome [15] 423415 0
Feasibility of the intervention. Teachers will be asked about study feasibility using one item developed by the research team.
Timepoint [15] 423415 0
Teachers will be assessed at 3-month and 12-month follow-ups.

Eligibility
Key inclusion criteria
Secondary schools will be eligible to participate if they:
• Cater for students from Years 7-12,
• Have at least 50 students per year group,
• Are a Government, Catholic or Independent school,
• Do not currently implement an existing mobile phone ban or restriction policy; and
• Can participate in the study throughout 2023 and including a follow-up in 2024
• Not classified as a special education school, which caters solely to students with developmental, physical, or behavioural disabilities

Children will be eligible to participate if they:
• Attend a school that consents to the study; and
• Are in years 7-12.

Parents/carers will be eligible to participate if they:
• Are the primary carer of a student in years 7-12; and
• The child in their care attends a school that has consented to the study.

Teachers will be eligible to participate if they:
• Are permanent or contract teacher at a school that has consented to participate; and
• Teaches a year 7-12 class over the intervention period.
Minimum age
11 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Schools that currently implement a mobile phone ban or restriction policy,
• Cannot participate in the study throughout 2023 and including a follow-up in 2024,
• Schools that are classified as special education schools, which cater solely to students with developmental, physical, or behavioural disabilities.

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)
Block randomisation in SAS program.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Schools will be stratified based on location (urban/rural) and sector (government/non-government) and randomised in a 1:1 ratio to the intervention or control condition by an independent statistician, not otherwise involved in the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be undertaken under an intention-to-treat (ITT) framework using 2-tailed statistical tests and an alpha of 0.05. Between group differences on the primary outcome will be assessed using logistic regression models (for binary outcomes) or linear regression models (for continuous outcomes) controlling for baseline values and adjusting for any school level clustering. We will apply multiple imputation methods for missing data at follow-up. Descriptive statistics, including 95% confidence intervals will be used to describe sample characteristics. All analyses will be conducted by a biostatistician using appropriate statistical software (e.g., R, SAS).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/07/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10950
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 314050 0
University
Name [1] 314050 0
The University of Newcastle
Country [1] 314050 0
Australia
Primary sponsor type
University
Name
The University of Newcastle
Address
University Dr, Callaghan NSW 2308.
Country
Australia
Secondary sponsor category [1] 315950 0
None
Name [1] 315950 0
Address [1] 315950 0
Country [1] 315950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313186 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 313186 0
Ethics committee country [1] 313186 0
Australia
Date submitted for ethics approval [1] 313186 0
20/04/2023
Approval date [1] 313186 0
26/05/2023
Ethics approval number [1] 313186 0
H-2023-0106

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

Contacts
Principal investigator
Name 127278 0
Dr Rachel Sutherland
Address 127278 0
The University of Newcastle, School of Medicine and Public Health, University Dr, Callaghan NSW 2308, Australia.
Country 127278 0
Australia
Phone 127278 0
+61 0423078789
Fax 127278 0
Email 127278 0
[email protected]
Contact person for public queries
Name 127279 0
Rachel Sutherland
Address 127279 0
The University of Newcastle, School of Medicine and Public Health, University Dr, Callaghan NSW 2308, Australia.
Country 127279 0
Australia
Phone 127279 0
+61 0423078789
Fax 127279 0
Email 127279 0
[email protected]
Contact person for scientific queries
Name 127280 0
Rachel Sutherland
Address 127280 0
The University of Newcastle, School of Medicine and Public Health, University Dr, Callaghan NSW 2308, Australia.
Country 127280 0
Australia
Phone 127280 0
+61 0423078789
Fax 127280 0
Email 127280 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


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.