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Trial registered on ANZCTR


Registration number
ACTRN12619001262190
Ethics application status
Approved
Date submitted
10/06/2019
Date registered
12/09/2019
Date last updated
12/09/2019
Date data sharing statement initially provided
12/09/2019
Date results information initially provided
12/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Implementing a taitamariki healthy relationship app in secondary schools – The Harmonised trial
Scientific title
Violence prevention: promotion of healthy relationships amongst high school students using a smartphone App
Secondary ID [1] 298218 0
MBIE: AITX1501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy adolescent relationships 312818 0
Condition category
Condition code
Public Health 311318 311318 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of the implementation of a smartphone app, accessible via iOS (i.e. Apple devices), Android (e.g. Chromebook) or the web, in each participating secondary school. The Harmonised app enables:
• Setting up a healthy relationship profile
• Accessing healthy relationship information
• Posting to friends & whanau for support (private social network)
The app supports two types of users. Primary users are students in the participating schools with access to all app functions. Secondary users consist of friends, family, whanau and community who have access to healthy relationship information only, unless invited as a primary user’s safe person to comment on specific posts.

Strategies to support app adoption include the use of posters and school newsletters.
The tailored nature of implementation limits evaluation of fidelity.

Mode of training: The implementation plan is developed jointly with each school and may be researcher- or school-led. The one-off single-period (40 to 50 minutes) implementation is delivered within individual classrooms or school assembly. A hard-copy training resource designed specifically for the study supports implementation, and includes instructions regarding app navigation and function. Researcher-led training includes demonstrations of app functions using Apple TV. Students are led through the process of registration, creation of user profiles and making posts.

Intended frequency/duration of use of the app is entirely at the participants' discretion.

Description of the healthy relationship information: This information is collated by a Harmonised resource working group following a Resource Protocol for the selection, modification and permission for resources. Resources include links to videos, quizzes, brief articles and stories from a range of sources (for example, from HELP, SHINE, NETSAFE). Sources are cited according to creative license and permissions. Topics covered include, for example, communication, consent, anger management, healthy relationships and sexuality. New Zealand material is prioritised; some of the material is in te reo Maori.

Harmonised Moderation Protocol. A moderation protocol guides safe practices for all posting (posts and comments). To minimise risk, the protocol addresses harm to primary app users, harmful use of the app and harm to the platform. The protocol includes automated (inappropriate language block and suicidality/self-harm automated message), human (research team daily review with ability to block text or user and escalation pathway), community (users report inappropriate content) and reputation-based moderation. User guides communicate to users the safe and responsible use of the app. The protocol is aligned to the New Zealand Harmful Digital Communications Act 2015.
Intervention code [1] 314458 0
Prevention
Intervention code [2] 314460 0
Behaviour
Comparator / control treatment
Pre-implementation from clustered cross-over design. All schools have a pathway for referral of students needing health and well-being services, including, for instance, social workers, counsellors and health providers. No control-period activities are undertaken affecting the participants. Pre-implementation focus groups with school stakeholders are held. The study team also engages with an identified school liaison during the control period to develop an implementation plan.
Control group
Active

Outcomes
Primary outcome [1] 320317 0
Relationship self-efficacy - Self score, measured by a score obtained from a 2-item questionnaire.

The questionnaire was designed specifically for this study by extracting and adapting two items from the Self-Efficacy to Deal with Violence Scale (Cameron et al., 2007).
Timepoint [1] 320317 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]). Stepped wedge design; no primary timepoint.
Primary outcome [2] 320537 0
Relationship self-efficacy - Others score, measured by a score obtained from a 2-item questionnaire.

The questionnaire was designed specifically for this study by extracting and adapting two items from the Self-Efficacy to Deal with Violence Scale (Cameron et al., 2007).
Timepoint [2] 320537 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]). Stepped wedge design; no primary timepoint.
Secondary outcome [1] 371230 0
WHOQoL-5 score. The introductory text and one item were adapted.
Timepoint [1] 371230 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]).
Secondary outcome [2] 371231 0
General health. Single 5-point Likert scale to rate respondent's general health.
Timepoint [2] 371231 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]).
Secondary outcome [3] 371232 0
Connectedness. Adapted from the Hemingway Measure of Adolescent Connectedness (Karcher, 2009) by removing the school subscale and regionalising the language.
Timepoint [3] 371232 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]).
Secondary outcome [4] 371233 0
Cybersafety, measured by a 15-item questionnaire designed for this and other studies.
Timepoint [4] 371233 0
Baseline, 10 weeks, 20 weeks, 30 weeks, 50 weeks (corresponding to New Zealand School terms 1, 2, 3, 4 [2018] and 1 [2019]).

Eligibility
Key inclusion criteria
Inclusion criterion for schools:
Maori roll > 15%.

Inclusion criteria for participants:
Enrollment in participating schools in year groups 9-13.
Able to consent and complete an online survey.
Minimum age
12 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster-randomised schools all agreed to participate prior to randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation using a computer-generated sequence of pseudo-variates. Schools were stratified by size (Small, Large) and by on-going standardised delivery of a Healthy Relationship Programme (e.g. Mates & Dates).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Stepped wedge design (cluster-randomised, one-directional crossover). A second wave of enrolment is planned in the second year of the study targeting the replacement of year group 9 students providing a single post-implementation assessment.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Recruitment of 8 schools and data collection over 5 terms was judged feasible, with app implementation (the intervention) scheduled at 2 time points (terms 2 and 3, respectively, in the first year). We assume roughly equal numbers of randomly selected participants from each school (one class in each year). We used the method of Hussey & Hughes (Contemporary Clinical Trials, 2007) to compute the power for different effect sizes under a model of the form
$$
Y_{itk} = \mu+\alpha_i+\beta_t+ x_{it}\theta+\epsilon_{itk}
$$
where $Y_{itk}$ is the primary outcome, $\alpha_i\sim N(0,\theta^2)$ is a school-related random effect, $i=1,\dots,8$, $\beta_t$ is a fixed effect associated with the term, $t=1,\dots,5$, with $\beta_1=0$ for identifiability, $x_{it}=0,1/2\mbox{ or }1$, respectively if $t$ precedes, is equal to, or follows the implementation term, $\theta$ is the intervention effect and $\epsilon_{itk}\sim N(0,\sigma^2_\epsilon$. Optionally, individual covariates $z_{ik}$ may also be included in the model; the decision will be made during a blind review of the data.

Assuming an attrition of 35% (conservatively applied to all assessment time points) and using a school-specific intraclass correlation of 0.07, evinced in a bullying study in New Zealand schools (Denny, Peterson, Stuart et al., Journal of School Violence, 2014), we obtain that recruiting 600 students is sufficient to detect an effect size of 0.25 with 83% power and of 0.30 with 94% power. These correspond respectively and approximately to a change of 0.75 and 0.9 in the mean score of the Relationship Self-Efficacy score, based on the baseline data.

The model above will be fitted using linear mixed effects modelling as implemented in R package lme4.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21595 0
New Zealand
State/province [1] 21595 0

Funding & Sponsors
Funding source category [1] 302758 0
Government body
Name [1] 302758 0
Ministry of Business, Innovation and Employment
Address [1] 302758 0
Level 8, 15 Stout Street
PO Box 1473
Wellington 6140
Country [1] 302758 0
New Zealand
Primary sponsor type
University
Name
Auckland University of Technology
Address
Private Bag 92006
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 302960 0
None
Name [1] 302960 0
Address [1] 302960 0
Country [1] 302960 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303359 0
Auckland University of Technology Ethics Committee (AUTEC)
Ethics committee address [1] 303359 0
AUTEC
Auckland University of Technology
Private Bag 92006
Auckland 1142
Ethics committee country [1] 303359 0
New Zealand
Date submitted for ethics approval [1] 303359 0
15/03/2017
Approval date [1] 303359 0
03/05/2017
Ethics approval number [1] 303359 0
AUTEC 17/71

Summary
Brief summary
The research team, with taitamariki (young people), recently developed the Harmonised app (smartphone application) for young people (aged 13- 17 years) to promote healthy intimate partner relationships. The App also provides a pathway for friends and whanau or family to learn how to offer better support. To test the app, we will conduct a special kind of randomised trial called a stepped wedge trial in eight secondary schools. That means that data collection will start in participating schools at the same time, but that each school will be assigned to introduce the app during a randomly assigned school term. The eight participating schools will be randomly assigned to implement the app. This project is Maori- (indigenous people of Aotearoa New Zealand) centred, with Maori participation across all aspects of the project.
Trial website
https://harmonised.co.nz/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93394 0
Prof Jane Koziol-McLain
Address 93394 0
Auckland University of Technology
Private Bay 92006
Auckland 1142
Country 93394 0
New Zealand
Phone 93394 0
+64099219670
Fax 93394 0
Email 93394 0
jane.koziol-mclain@aut.ac.nz
Contact person for public queries
Name 93395 0
Prof Jane Koziol-McLain
Address 93395 0
Auckland University of Technology
Private Bay 92006
Auckland 1142
Country 93395 0
New Zealand
Phone 93395 0
+64099219670
Fax 93395 0
Email 93395 0
jane.koziol-mclain@aut.ac.nz
Contact person for scientific queries
Name 93396 0
Prof Jane Koziol-McLain
Address 93396 0
Auckland University of Technology
Private Bay 92006
Auckland 1142
Country 93396 0
New Zealand
Phone 93396 0
+64099219670
Fax 93396 0
Email 93396 0
jane.koziol-mclain@aut.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have consent
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 4495 0
Informed consent form
Citation [1] 4495 0
Link [1] 4495 0
Email [1] 4495 0
jane.koziol-mclain@aut.ac.nz
Other [1] 4495 0
Attachment [1] 4495 0
Type [2] 4496 0
Ethical approval
Citation [2] 4496 0
Link [2] 4496 0
Email [2] 4496 0
jane.koziol-mclain@aut.ac.nz
Other [2] 4496 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary