Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000968471
Ethics application status
Approved
Date submitted
1/07/2016
Date registered
22/07/2016
Date last updated
9/06/2022
Date data sharing statement initially provided
9/06/2022
Date results information initially provided
9/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Altitudes: Moderated online social therapy for carers of young people recovering from first-episode psychosis:
Scientific title
Effect of Moderated Online Social Therapy for carers of first-episode psychosis clients on carer stress and wellbeing: a randomised controlled trial
Secondary ID [1] 287468 0
Nil
Universal Trial Number (UTN)
U1111-1174-7272
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Perceived stress associated with caring for a young person with first-episode psychosis. 296200 0
Objective stress 296902 0
Carer depression 298141 0
Carer self-effiacy (We will be measuring parenting self-efficacy as well as personal agency, self-sufficiency and self-management.) 298142 0
Perceived social support / loneliness 298143 0
Coping (we will be measuring cognitive-escape coping, optimistic coping, seeking connections, tension reduction, and distancing) 298144 0
Worry 298905 0
Satisfaction with life 298906 0
Substance use 298908 0
Well being 298909 0
Condition category
Condition code
Mental Health 296475 296475 0 0
Depression
Mental Health 299525 299525 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our online application, entitled “Altitudes”, integrates purpose-built online social networking, expert and peer moderation, and evidence-based psychoeducation within a single application. Specifically, Altitudes, utilizes our Moderated Online Social Therapy (MOST) software framework, the three major functions of this framework include: (i) online psychoeducation (divided into specific thematic pathways which are further separated into individual “steps”); (ii) expert moderated social networking (via a “cafe menu”); and (iii) peer moderation.
New users are given a one hour face to face introductory welcome or “induction” to Altitudes with a trained research assistant. The research assistant highlights ways to optimise their use of the system and how to access system help. Uses are invited to complete, at their own convenience, a series of “pathways” organised into distinct themes including self-care, understanding psychosis, early warning signs and prevention of relapse, understanding their personal strengths as a carer, managing behavioural problems in their relative, and communicating with their relative. These pathways are divided into thematically-related psychoeducation steps to maximize the usability of the material. The content of these steps, which entail narrative examples, has been specifically designed to improve carer stress, e.g., by encouraging self-care and by targeting problematic appraisals known to increase carer stress. In addition, the content of the steps have been influenced by social cognition concepts of “agency” and self-efficacy in family life. The steps and pathways entail regular prompts to users to share their reactions to material with other users through a series of “talking points”. Users’ responses populate the content of the social networking newsfeed. In addition, users are able to indicate their preference for material through “like” buttons, share content with others users, and are able to keep track of which users have completed specific pathways and which users share their specific personal strengths.
Users of Altitudes are encouraged to communicate with other users and with moderators through the online “cafe” where all other users are visible in the “network” page. Expert and peer moderators are also identifiable as separate classes of users within the network. Users can visit the “wall” of fellow users where posts (and comments upon posts) are displayed along with profile information and images uploaded by each user. Within each user’s home page the moderators can promote specific content, including suggested actions, which are also related to specific “steps”. A group problem solving function, entitled “talk it out” is also featured which is based upon moderated problem solving from multi-family therapy research which has a well-established evidence base for its effectiveness in psychosis. Users can suggest everyday problems in caring for their relative, and the moderator invites other users to join in the problem solving “group”. The system stores previous problems and solutions, providing an easily accessible “solution wiki” to subsequent users. The social networking combined with problem solving and psychoeducation has been designed to provide social support, increase carers’ understanding of their relative’s disorder, and increase flexibility of interpersonal problem solving and communication.
Expert moderators, who are clinical psychologists with specialist family work experience, log on to Altitudes at daily intervals with the goal of monitoring safety and encouraging self-care, self-efficacy and positive coping within families. Peer moderators model use of the system and facilitate interactions. Expert moderators present formulations of users at weekly supervision sessions including analyses of system activity and planned interventions to optimise users’ activity. Formulations focus on promoting engagement and targeting their clinical needs. Moderators identify users who are at risk of reduced engagement and form a follow-up plan.
Each Altitudes user can log on to the system at their convenience, 24 hours a day, 7 days a week. They will have access to the intervention for at least 6 months with a maximum duration of 20 months. The application is accessible from any device (e.g., personal computer, tablet, mobile phone) and from any location that has access to the internet. In addition to the online intervention, carers will have access to the usual array of services for carers at The Early Psychosis Prevention and Intervention Centre (EPPIC), a comprehensive mental health service at Orygen Youth Health in Melbourne. This includes access to: (i) a series of 3 group-based evening psychoeducation sessions entitled “Family and Friends”; (ii) psychoeducation and support to carers from EPPIC outpatient casemanagers; (iii) specialist family therapist sessions in specific cases, for example where there is a high level of behavioural problems faced by the family. A resource document outlining local support services and 24-hour helplines, will be provided to those participants who present as highly stressed and in need of extra support. These participants will be encouraged to refer themselves to a service such as Carers Victoria or to a GP for their own therapy or counselling.
Altitudes users (intervention group only) will be invited by moderators to meet the research team and other users at ‘Altitudes workshops’. These will be offered every 6 months (approx. twice per year) to all Altitudes users. These workshops will be held at a central location convenient to participants. The Altitudes workshops will provide users with the opportunity to ask questions and give informal feedback on the system. It is also intended that the workshops will be a social event, which will assist with engagement with the intervention and encourage online interaction between Altitudes users, participants, and moderators. The workshop protocol is informed by accepted Human Computer Interaction design models for the health arena (specifically mental health) (Doherty 2010) which suggest regular focus groups with participants as a way of refining designs. The workshops will be facilitated by the online moderators, as well as senior researchers and research assistants
Moderation integrity will be ensured through a moderation manual and weekly to fortnightly group supervision sessions with senior clinical researchers from the team (CI-Gleeson, CI-Alvarez, CI-Bendall). In addition, moderator online actions will be randomly selected for coding against the guidelines detailed in the Altitudes moderation manual by an independent rater. The group has previously developed reliable fidelity procedures which have been adapted for this trial (Alvarez-Jimenez et al. 2008).
Intervention code [1] 292845 0
Treatment: Other
Intervention code [2] 294399 0
Lifestyle
Intervention code [3] 294400 0
Behaviour
Comparator / control treatment
All carers will have access to the usual array of services for carers at EPPIC. This includes access to: (i) a series of 3 group-based evening psychoeducation sessions entitled “Family and Friends”; (ii) psychoeducation and support to carers from EPPIC outpatient casemanagers; (iii) specialist family therapist sessions in specific cases, for example where there is a high level of behavioural problems faced by the family. A resource document outlining local support services and 24 hour helplines, will be provided to participants who present as highly stressed and in need of extra support. These participants will be encouraged to refer themselves to a service such as Carers Victoria or to a GP for their own therapy or counselling.

Control group
Active

Outcomes
Primary outcome [1] 296101 0
The primary outcome will be carer perceived stress at 6 months measured by The Perceived Stress Scale PSS (Cohen & Williamson, 1988). The PSS will be employed to measure perceived stress over the preceding 1 month. The PSS is a valid and reliable 10-item measure rated on a Likert scale ranging from 0 (never) to 4 (very often).
Timepoint [1] 296101 0
The PSS will be collected at baseline, 3 months, and 6 months post baseline The design includes two assessment major time points, namely, baseline and 6-months follow up. One 10-item measure will be collected over the phone at approximately 3 months after the baseline assessment, where practical. The primary endpoint is 6 months. .
Secondary outcome [1] 317505 0
Objective stress will be measured by obtaining a hair sample. Hair cortisol will be used as a biomarker of chronic stress (Van Uum 2008) via long-term alterations in basal hypothalamic-pituitary-adrenal (HPA) axis activity (Davenport 2006). Mean baseline HPA system activity during the last month will be measured by a validated procedure for measuring hair cortisol (Davenport 2006). A single hair sample (3cm long, approximately 0.5 cm in diameter) will be collected from a posterior vertex region on the head. It will be cut from a 0.5 cm patch using scissors as close to the scalp as possible, as recommended by the Society of Hair Testing. The hair samples will be wrapped in aluminum foil for protection and stored in plastic tubes. Analyses of cortisol in hair will be performed at the Stratech Scientific APAC laboratory in Sydney according to the established protocol by Davenport et al (Davenport 2006). Cortisol concentrations in a 1 cm hair segment will provide a retrospective index of the mean cortisol secretion over the past month (Kirschbaum 2009) . Hair analyses of cortisol have recently been reported to be a useful tool to assess long-term systemic cortisol exposure (Russell 2012).
The PSS has been commonly used in conjunction with hair cortisol measurements (O'Brien 2013)
Timepoint [1] 317505 0
Baseline and 6 month follow up.
Secondary outcome [2] 317506 0
Carer depression will be measured by the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R) – a 20-item self-report scale of nine depressive symptoms.
Timepoint [2] 317506 0
Baseline and 6 month follow up.
Secondary outcome [3] 317507 0
Carer self-efficacy will be measured by the “Me as a Parent” Questionnaire. This 16 item questionnaire measures parenting self-efficacy as well as personal agency, self-sufficiency and self-management.
Timepoint [3] 317507 0
Baseline and 6 month follow up.
Secondary outcome [4] 317508 0
Loneliness will be measured by the UCLA Loneliness Scale (version 3)
Timepoint [4] 317508 0
Baseline and 6 month follow up.
Secondary outcome [5] 317509 0
Coping will be measured via the self-report Ways of Coping (WOC) scale using the follow 6 subscales: confrontive, distancing, self-controlling, planful problem solving and escape-avoidance
Timepoint [5] 317509 0
Baseline and 6 month follow up.
Secondary outcome [6] 324186 0
Perceived social support will be measured by the Medical Outcomes Study: Social Support Survey (MOS-SSS).
Timepoint [6] 324186 0
Baseline and 6 month follow up.
Secondary outcome [7] 324187 0
Strengths use will be assessed by means of the Strengths Use Scale (SUS; Wood et al., 2010).
Timepoint [7] 324187 0
Baseline and 6 month follow up.
Secondary outcome [8] 324188 0
Self-Compassion will be assessed by the Self-Compassion Scale Short Form (SCS-SF; Raes et al., 2011).
Timepoint [8] 324188 0
Baseline and 6 month follow up
Secondary outcome [9] 324189 0
Mindfulness will be measured using the dispositional Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Timepoint [9] 324189 0
Baseline and 6 month follow up.
Secondary outcome [10] 324190 0
Satisfaction with Life will be assessed by the Satisfaction With Life Scale (SWLS).
Timepoint [10] 324190 0
Baseline and 6 month follow up
Secondary outcome [11] 324191 0
Substance use will be assessed by the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) version 3.0, WHO ASSIST Working Group, 2002
Timepoint [11] 324191 0
Baseline and 6 month follow up
Secondary outcome [12] 324192 0
Cost-effectiveness as measured by the AQoL 8D (AQoL-8D; Richardson et al., 2011), which allows for the calculation of Quality-Adjusted Life Years (QALYs).
Timepoint [12] 324192 0
Baseline and 6 month follow up
Secondary outcome [13] 324193 0
Cost-effectiveness as measured by Resource Use Questionnaire (RUQ) will be used to determine the broader resource use of participants.
Timepoint [13] 324193 0
Baseline and 6 month follow up
Secondary outcome [14] 324194 0
The Family Questionnaire (FQ) (Wiedemann 2002) will measure the level of expressed emotion, emotional over-involvement and criticism in the relatives of people diagnosed with FEP)
Timepoint [14] 324194 0
Baseline and 6 month follow up
Secondary outcome [15] 324195 0
Experience of Care-giving Inventory (ECI) (Szmukler 1996) will measure caregivers' appraisal of the impact of the illness on the family.
Timepoint [15] 324195 0
Baseline and 6 month follow up
Secondary outcome [16] 324196 0
The Parent- Adolescent Communication (PAC) Scale, 20 item self-report measure will be used to assess communication and the quality of the relationship of care givers and their young person by measuring the degree of openness and extent of problems in family communication
Timepoint [16] 324196 0
Baseline and 6 month follow up
Secondary outcome [17] 324197 0
Intervention group only - Perceived competence using Altitudes will be measured by the Altitudes Perceived Competence Scale (A-PCS; Williams et al., 1998)
Timepoint [17] 324197 0
Baseline and 6 month follow up
Secondary outcome [18] 324198 0
Intervention group only - Motivation for using Altitudes will be assessed through the Altitudes Self-Regulation Questionnaire (A-SRQ; Ryan et al., 1995).
Timepoint [18] 324198 0
Baseline and 6 month follow up
Secondary outcome [19] 324199 0
Intervention group only - Users’ perception of Altitudes moderation will be assessed via the Altitudes Health Care Climate Questionnaire (A-HCCQ; Williams et al., 1996).
Timepoint [19] 324199 0
6 month follow up
Secondary outcome [20] 324200 0
Intervention group only - Usage of Altitudes (A-Usage) will be measured by monitoring usage of the online system across the study intervention period (i.e. frequency, duration and patterns of use).
Timepoint [20] 324200 0
6 month follow up

Eligibility
Key inclusion criteria
Inclusion criteria for the study will be carers (e.g., parent, grandparent, spouses) of a young person (age 15-27 years inclusive) who is currently receiving treatment for first-episode psychosis, or who have been recently discharged from specialist care. More than one family member will be eligible to participate from each family. Participants will be recruited from The Early Psychosis Prevention and Intervention Centre (EPPIC), a program of Orygen Youth Health in Parkville and Sunshine, Melbourne. EPPIC clients (a) have a diagnosis of a first episode of a DSM-IV psychotic disorder or mood disorder with psychotic features; (b) are aged 15-27 years inclusive; (c) have less than or equal to 6 months treatment with an antipsychotic medication prior to registration with the early psychosis service.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Carers who are currently engaged in legal action (e.g., intervention order) against the identified patient

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)
Initial contact will occur between the prospective participants and the study research assistant (RA) in three ways: (i) participants will respond to an advertisement and telephone the study RA directly; (ii) the family support worker will gain verbal consent from the primary carer for the study RA to telephone them; (iii) the outpatient case manager will gain verbal consent for the study RA to telephone them.

Advertisements will be placed in the waiting area and corridors at Orygen Youth Health Clinical Program and telephone calls will also be a mode of first contact with potential participants.

The primary carer will be asked if there are any other members of the family who would be interested in being invited to participate in the study.

The Research Assistant (RA) will meet face-to-face at Orygen Youth Health or in a location convenient to the prospective participant. At the meeting the study RA will present the information regarding the study in writing and orally and will invite prospective participants to ask any questions about any aspect of the study that is not clear.

Randomisation occurs after the baseline assessments are completed by all family members who have consented to the study. When each member of a newly recruited family provides informed consent and completes the baseline assessment, the study RA informs the independent statistician who subsequently informs the study coordinator and investigators via an automated email of the outcome of randomization. The study coordinator informs the family.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Families are the unit of randomisation. This allows for multiple members of the one family to participate in the study and ensuring they are allocated to the same treatment arm. Families are randomised to Altitudes+STAU or to STAU alone at the ratio 1:1. We expect that participant numbers within clusters (i.e., families) are likely to vary from between 1 to 4 with a mean cluster size estimate of 1.3. An independent statistician created the randomisation sequence, which includes permutated block. The block sizes and randomisation sequence are concealed from the study RA and investigators.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between-group differences on the primary outcome will be examined using mixed model repeated measures (MMRM) which are the preferred methods for the analysis of clinical trial data in psychiatry. Individual time-point measures can be considered to be nested within individual carers, who may also be considered to be nested within individual families. MMRM will be used for the analysis of primary and secondary outcome measures. MMRM enables analysis of hierarchically structured data (e.g., allows for violations of assumptions such as homogeneity of regression slopes across time points and effects at the family level) whilst allowing maximum flexibility in the case of missing data.

We will assume that moderate to large effect sizes will be obtained for the primary outcome of stress. We estimate based on previous trials including carers at EPPIC that the cluster size will be small, (approx. 1.3) because in most cases there will only be one family member involved. An approximate estimate of the intra-cluster correlation for stress measures is .20. In most cases this would be the two parents/partners which would minimise the influence of genetic effects. In addition, patients’ symptoms account poorly for variance in carer measures of stress, so the estimation of intra-cluster correlation may even be inflated. Therefore, we estimate that the design effect will be approximately .26.

For continuous measures, if we are to assume that alpha is set at 0.05, power (1-beta) at 0.80, then a sample size of 64 is required for each of the two groups (Total n=128). A study by Rotondi and colleagues (2010) which included randomization to a multi-family web-based intervention reported a drop-out rate of 3% at the 12-month follow up, highlighting the acceptability of the design. Taking a more conservative estimate and assuming an attrition rate in the proposed study of approximately 20% at follow up, we aim to recruit 160 family members at baseline to retain 128.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/10/2015
Date of last participant enrolment
Anticipated
1/12/2016
Actual
4/08/2017
Date of last data collection
Anticipated
Actual
3/07/2018
Sample size
Target
160
Accrual to date
Final
164
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5856 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 13297 0
3020 - Sunshine
Recruitment postcode(s) [2] 13296 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 292041 0
Government body
Name [1] 292041 0
Australian Government’s Collaborative Research Networks (CRN) program
Country [1] 292041 0
Australia
Primary sponsor type
University
Name
The Australian Catholic University
Address
115 Victoria Parade Fitzroy
Victoria 3065
Country
Australia
Secondary sponsor category [1] 290712 0
University
Name [1] 290712 0
University of Melbourne
Address [1] 290712 0
156-292 Grattan St, Parkville, Vic 3010
Country [1] 290712 0
Australia
Secondary sponsor category [2] 290713 0
Other
Name [2] 290713 0
Orygen, The National Centre of Excellence in Youth Mental Health
Address [2] 290713 0
35 Poplar road, Parkville, Victoria, 3052
Country [2] 290713 0
Australia
Secondary sponsor category [3] 291844 0
Hospital
Name [3] 291844 0
Melbourne Health
Address [3] 291844 0
Royal Melbourne Hospital, 300 Grattan St Parkville VIC 3050

Country [3] 291844 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293525 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 293525 0
300 Grattan St, Parkville, Vic, 3050
Ethics committee country [1] 293525 0
Australia
Date submitted for ethics approval [1] 293525 0
24/07/2014
Approval date [1] 293525 0
09/10/2014
Ethics approval number [1] 293525 0
2014.175

Summary
Brief summary
The focus of this program of research is on carers of young people (aged 15-27 years) diagnosed with a first episode of psychosis. The proposed research program is a randomised controlled trial (RCT) which will examine the effectiveness of a novel online intervention for improving carer stress. The key research question is: can an innovative web-based intervention entitled “Altitudes”, which utilises moderated online social networking therapy (MOST), lead to improvements in stress at 6 month follow up in carers with a relative receiving treatment for a first episode psychosis, when added to specialist first-episode family work?

The primary hypothesis is that carers randomised to the Altitudes online application+STAU will report significantly less stress at 6 months follow up compared with carers randomised to specialist family treatment as usual (STAU). The secondary hypothesis is that carers randomised to Altitudes will experience reduced objective stress, improved positive coping, self-efficacy, depression and perceived social support compared with carers randomised to STAU at 6-months follow up.
Trial website
Trial related presentations / publications
Public notes
ONLINE SAFETY OF PARTICIPANTS

A rigorous safety protocol has been developed by the researchers in conjunction with experts from the computing and information systems discipline. The safety protocol is comprised of 3 levels of security including: 1) system and privacy protection, 2) online safety, and 3) clinical safety.

System and privacy protection: A range of measures are in place to help ensure the security of the website. The application is hosted on a University of Melbourne web server. The University has standard measures in place to prevent unauthorised access to the server. In addition, the web application includes measures to secure the application and database against unauthorised access. These measures conform to industry best practice as defined by the Open Web Application Security Project (www.OWASP.org).

Online safety: Privacy and on­line safety will be managed in accordance with the 'Online social networking' guidelines published by 'Cybersmart', a national cybersafety and cybersecurity education program managed by the Australian Communications and Media Authority (ACMA). Cybersmart is designed to meet the needs of its target audiences of young people, parents, teachers and library staff. Information about Cybersmart can be found at http://www.cybersmart.gov.au/, while the guidelines are available at http://www.acma.gov.au/.

Safe and informed orientation to the system will be a priority for the research team. As part of the induction process Altitudes participants are informed of the terms of use. Hard copies of ‘Altitudes Terms of Use’ are provided to users, which are available online and in printed form. Participants are required to sign the hard copy as well as accepting the terms of use on entry into the system. The system also includes a "report function" which enables users at any time to indicate to the moderator a concern about any material posted by a user, including concern about potential abuse. The moderator will assess the basis of the report and respond accordingly, which can include the removal of the material and in some cases the deactivating or restriction of the user's account. In addition, users will be able to "switch off" their profile and hide all of their existing comments on the system should they become concerned about their privacy during their course of participation. The limits of the moderator to respond (e.g., in a timely manner) are also fully explained. If participants do not comply with the guidelines for safe use of Altitudes (e.g., discriminatory comments towards other users; disclosing identifying details of the identified patient) they will be excluded from the system.

Clinical safety: It is possible that participants may post information indicative of a clinical risk in their relative, although participants will be advised that the service cannot respond to emergencies. Nonetheless, clinical risk will be monitored through manual and automated procedures. Information related to clinical risk will be screened during weekdays by moderators and during weekends by the senior researchers. This information can include: 1) posts made by participants, which disclose evidence of deterioration in mental state of the young person in the care of participants; 2) participants reports or complaints on posts made by other users; and 3) automatically detected and blocked words posted by participants in the system. Any detected increased risk will activate the Altitudes safety protocol which includes a number of potential actions. Initially, the moderator will conduct a risk assessment based upon available information, inform the research team, and advise the participant on appropriate action (i.e., YAT, appropriate local CAT team, etc.). In addition, the system incorporates visible emergency guidelines and contact information (i.e., on every webpage). Telephone numbers and contact details, including YAT, will be provided on each page of the website. All participants will have access to the full array of usual treatments, including face­to­face clinical risk monitoring by EPPIC clinicians during the episode of care.
An automated keyword system has also been built in Altitudes which will be activated each time a participant posts a contribution containing potentially offensive words. When these words are detected the contribution will be blocked and the participant will be sent an automated email explaining that the message has been blocked and if they are facing distress then they should contact the emergency contact number as soon possible or if they are not facing distress they may like to consider rephrasing their post. An automated email will also be sent to the Altitudes moderator containing the attempted post.
In addition, a message will be available on each page providing a mobile telephone number carried by a member of the research team for any emergencies that are related specifically to the use of the Altitudes’ system (e.g., highly inappropriate use of the system).

Withdrawal criteria: Temporary or permanent withdrawal from Altitudes will be triggered by repeated inappropriate use of the system. This can include either suspension of a users' Altitudes account or restrictions regarding participation and use of Altitudes (i.e., the user is able to access therapeutic content and support from moderators, but cannot post comments or participate in existing threads within the social network).

Monitoring of adverse events:
System and privacy protection will be monitored by the study programmer. On­line safety will be monitored by the Altitudes moderator with supervision from the senior researchers. The moderator will have the authority to respond to on­line reports (e.g., remove offending material from the system) and automated emails.

Clinical safety will be monitored proactively by the moderators through daily monitoring of the activity on Altitudes. In addition, information related to well being of participants could be brought to the attention of the research team from two potential sources: a) the online moderators via daily monitoring of the site; and, b) the RA at an interview.
The research team will respond according to a risk management algorithm (see attachment to ANZCTR registration form), which outlines the required response to potential indicators of clinical risk in terms of the source of the information. If the online moderator becomes aware of potential indicators of risk in the online application they will conduct an initial risk assessment, make the appropriate clinical response and inform the supervisor. If the study RA becomes aware of an indicator of clinical risk they will inform their supervisor who will again respond clinically. The supervisor will assess the criteria for withdrawal and potential suspension of usage restriction to a user’s Altitudes account. The principal investigator (Professor Gleeson) will have ultimate responsibility for withdrawing participants from the study or restricting their Altitudes account.

Reporting of adverse events:
Any adverse outcomes for participants, such as exposure to potentially harmful interactions through the social networking, will be reported to the ethics committee. In the event that a participant informs the moderators of an adverse event relating to the young person in their care or of any signs of deterioration in their mental health, the Altitudes moderators will communicate with the relevant clinicians where indicated.
Attachments [1] 904 904 0 0
/AnzctrAttachments/369314-Altitudes safety Algorithm.docx

Contacts
Principal investigator
Name 60314 0
Prof John Gleeson
Address 60314 0
School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065
Country 60314 0
Australia
Phone 60314 0
+61 3 9953 3108
Fax 60314 0
Email 60314 0
john.gleeson@acu.edu.au
Contact person for public queries
Name 60315 0
A/Prof Mario Alvarez
Address 60315 0
Orygen, The National Center of Excellence in Youth Mental Health, Locked Bag 10, Parkville VIC 3052 Australia
Country 60315 0
Australia
Phone 60315 0
+61 3 9342 2800
Fax 60315 0
Email 60315 0
malvarez@unimelb.edu.au
Contact person for scientific queries
Name 60316 0
Prof John Gleeson
Address 60316 0
School of Psychology, 115 Victoria Parade, Australian Catholic University, Fitzroy, VIC 3065
Country 60316 0
Australia
Phone 60316 0
+61 3 9953 3108
Fax 60316 0
Email 60316 0
john.gleeson@acu.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants did not provide consent for their individual participant data (IPD) to be used for any other trial/research.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16345Study protocolGleeson, J., Lederman, R., Herrman, H. et al. Moderated online social therapy for carers of young people recovering from first-episode psychosis: study protocol for a randomised controlled trial. Trials 18, 27 (2017). https://doi.org/10.1186/s13063-016-1775-5https://doi.org/10.1186/s13063-016-1775-5 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseModerated online social therapy for carers of young people recovering from first-episode psychosis: Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-016-1775-5
EmbaseA randomized controlled trial of moderated online social therapy for family carers of first-episode psychosis patients in a specialist treatment setting.2023https://dx.doi.org/10.1016/j.schres.2023.03.019
N.B. These documents automatically identified may not have been verified by the study sponsor.