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Trial registered on ANZCTR


Registration number
ACTRN12618000616279
Ethics application status
Approved
Date submitted
27/03/2018
Date registered
20/04/2018
Date last updated
5/04/2019
Date data sharing statement initially provided
5/04/2019
Date results information initially provided
5/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Kindred: A pilot study of moderated online social therapy for carers of youth with borderline personality disorder
Scientific title
Kindred: A pilot study of moderated online social therapy for carers of youth with borderline personality disorder
Secondary ID [1] 294202 0
Nil known
Universal Trial Number (UTN)
U1111-1210-1140
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
borderline personality disorder 306839 0
Condition category
Condition code
Mental Health 305940 305940 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Kindred is a Moderated Online Social Therapy (MOST) program. Kindred comprises three highly integrated functions within one web-based application. These include: (1) online psychoeducation and interactive therapy (divided into 9 specific thematic pathways which are further separated into individual "steps"); (2) expert moderated social networking (via a "cafe"); and, (3) peer moderation. Each user can log on at their convenience, 24 hours per day and as many times as they wish.

The online psychoeducation and interactive therapy
Users complete, at their own convenience, a series of 9 "pathways" organised into distinct themes including understanding BPD, self-care, understanding and utilising their personal strengths as a carer, responding to behavioural problems in their relative, and communicating with their relative. In order to maximize the usability of the material, these pathways are comprised of brief thematically related psychoeducation and interactive therapy "steps". There are 45 'steps' in total across the Kindred program. The content of these steps has been specifically designed to improve carer stress, e.g., by encouraging self-care, by facilitating carer self-efficacy, and by targeting problematic appraisals known to increase carers' stress. In addition, the content of the steps have been influenced by concepts from social cognition theory, namely, agency and self-efficacy in family life. The 45 steps and 9 pathways entail regular prompts to users to share their reactions to the material with other users through a series of "talking points". To ensure that psychoeducation is translated into meaningful behavioural change, we built specific actions entitled "do its", which are related to therapy content (e.g., to practice specific communication skills with their relative) and to users' specific strengths. Users' comments on steps and completed actions populate the content of the social networking newsfeed. In addition, users are able to indicate their preference for material through "like" buttons, rate the relevancy of content, share content with others users, keep track of which users have completed specific pathways, and identify other users who share their personal strengths. Users can also utilise a "team up" function to indicate their support or join other users in striving for specific behaviour change.

The social networking features
Users of Kindred are encouraged to communicate with each other and with moderators through the online "cafe" where all other users are visible in the "network" page. The professional moderator (described below) is identifiable as a separate class 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. Moderators can promote specific content within each user's home page, including suggested actions, which moderators select based upon individual users' strengths and motivations to use the system. The café menu also includes a group problem solving function, entitled "talk it out", which was derived from moderated problem solving as outlined in multifamily therapy research. Users can suggest everyday problems in caring for their relative, and moderators invite 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.

Moderation
New users are inducted into Kindred with an orientation to the system, including providing passwords and highlighting ways to optimise Kindred's use and ways to access system help. A professional moderator, (a clinical psychologist), with specialist family work experience, logs on to Kindred at daily intervals with the goal of monitoring safety and encouraging self-care, self-efficacy and positive coping within families by making comments on the newsfeed and sending direct messages to users. A peer moderator, (with lived experience of caring for a relative with severe mental illness), models use of the system and facilitates online interactions. Moderators present formulations of users at weekly supervision sessions including analyses of system activity and planned interventions to optimise users' engagement, and address any specific clinical need by suggesting content matched to users' interests and needs. Through analytics available on the back-end moderator interface, moderators identify users who are at risk of reduced engagement and form a follow-up plan, which might include prompts to log on or suggestions about Kindred content that matches with the users' identified needs and interests. Our approach to online moderation was inspired by the Supportive Accountability framework of ehealth interventions, which highlights that human support is critical to ensuring a necessary level of engagement in ehealth systems. Supportive accountability incorporates self-determination theory, which accounts for individual differences in motivation in terms of the fundamental human needs of relatedness, competency, and autonomy. Moderators develop individualised formulations regarding users' level of motivation to use Kindred and how their specific needs can best be addressed to optimise system engagement. Moderators will organise and invite users to at least one Kindred "meet up", offline face-to-face gatherings held during the course of the trial. The Kindred meet ups are designed to provide users with the opportunity to ask the expert moderators questions and give feedback on the system and encourage increased online interaction between Kindred users and moderators.
Intervention code [1] 300574 0
Treatment: Other
Intervention code [2] 300575 0
Lifestyle
Intervention code [3] 300576 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305099 0
Acceptability, as measured by:
(i) the number of log ins to the Kindred intervention, with acceptability achieved if 50% of carer participants log on at an average rate of more than once per fortnight across each period of their registration in Kindred;
(ii) Post-Study Usability Questionnaire (PSSUQ) administered to carers; and
(iii) a semi-structured interview designed specifically for this study, informed by the User Experience approach, and conducted with carer participants.
Timepoint [1] 305099 0
Kindred log ins for the duration of the Kindred intervention.
PSSUQ and semi structured interview at carer assessment 3-months after the baseline assessment.
Primary outcome [2] 305100 0
Safety, as measured by:
(i) a semi-structured interview designed specifically for this study, informed by the User Experience approach, and conducted with carer participants. Kindred will be considered safe if all participants report feeling adequately supported by the moderators at interview.
(ii) number of carer participants excluded from the Kindred system during the course of the intervention due to inappropriate conduct. Kindred will be considered safe if two or less participants are excluded.
(iii) unlawful entries into the Kindred system. Kindred will be considered safe if there are no unlawful entries.
(iv) carer participant withdrawal from the Kindred system due to adverse impacts on the wellbeing of participants associated with the use of the system. Kindred will be considered safe if there are no withdrawals.
Timepoint [2] 305100 0
Semi structured interview at carer assessment 3-months after the baseline assessment.
Kindred use for the duration of the intervention.
Secondary outcome [1] 344159 0
Change in carers' stress levels, as measured by:
(i) the Perceived Stress Scale (PSS) administered to carer participants;
(ii) carer hair cortisol levels; and
(iii) a questionnaire designed for this study administered by the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with carers.
Timepoint [1] 344159 0
Carer assessment 3-months after the baseline assessment, compared with baseline assessment.
Secondary outcome [2] 344160 0
Change in carers' level of expressed emotion, as measured by:
(i) the Family Questionnaire (FQ) administered to carer participants; and
(ii) a questionnaire designed for this study administered by the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with carers.
Timepoint [2] 344160 0
Carer assessment 3-months after the baseline assessment, compared with baseline assessment.
Secondary outcome [3] 344161 0
Change in carers' perceived burden, as measured by (i) the Experience of Caregiving Inventory (ECI) administered to carer participants.
Timepoint [3] 344161 0
Carer assessment 3-months after the baseline assessment, compared with baseline assessment.
Secondary outcome [4] 344162 0
Change in carers' perception of family interactions and communication, as measured by:
(i) the Parent-Adolescent Communication Scale (PAC) administered to carer participants; and (ii) a questionnaire designed for this study administered by the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with carers.
Timepoint [4] 344162 0
Carer assessment 3-months after the baseline assessment, compared with baseline assessment.
Secondary outcome [5] 344163 0
Change in carers' perceived knowledge of personality disorders, as measured by (i) selected items from the Personality Disorder Knowledge Attitudes and Skills Questionnaire (PDKASQ), modified for administration with carer participants.
Timepoint [5] 344163 0
Carer assessment 3-months after the baseline assessment, compared with baseline assessment.
Secondary outcome [6] 344164 0
Change in carers' quality of life, as measured by (i) the Assessment of Quality of Life (AQoL-4D) administered to carer participants.
Timepoint [6] 344164 0
Carer assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [7] 344165 0
Change in carers' functioning, as measured by:
(i) the World Health Organisation Disability Assessment Schedule (WHODAS 2.0) administered to carer participants; and
(ii) the Sheehan Disability Scale (SDS) administered to carer participants.
Timepoint [7] 344165 0
Carer assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [8] 344167 0
Change in carers' coping, as measured by (i) the Coping Inventory for Stressful Situation - Situation Specific Coping (CISS-SSC) administered to carer participants.
Timepoint [8] 344167 0
Carer assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [9] 344168 0
Change in carers' distress levels, as measured by:
(i) the Kessler-10 questionnaire (K-10) administered to carer participants; and
(ii) a questionnaire designed for this study administered by the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with carers.
Timepoint [9] 344168 0
Carer assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [10] 344171 0
Change in clients' borderline personality disorder (BPD) severity, as measured by (i) the Borderline Symptom List (BSL-23) administered to client participants.
Timepoint [10] 344171 0
Client assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [11] 344172 0
Change in clients' stress, as measured by (i) the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with clients.
Timepoint [11] 344172 0
Client assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [12] 344173 0
Change in clients' expressed emotion, as measured by (i) the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with clients.
Timepoint [12] 344173 0
Client assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [13] 344174 0
Change in clients' perception of family interaction and communication, as measured by (i) the Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with clients.
Timepoint [13] 344174 0
Client assessment 3-months after the baseline assessment, compared with the baseline assessment.
Secondary outcome [14] 344175 0
Change in clients' distress (depression and anxiety), as measured by the (i) Smartphone Ecological Momentary Assessment (SEMA) app eight times per day over a seven-day period at random intervals with clients.
Timepoint [14] 344175 0
Client assessment 3-months after the baseline assessment, compared with the baseline assessment.

Eligibility
Key inclusion criteria
There are two types of participants in this trial: (i) youth with borderline personality disorder (BPD) pathology, i.e. youth with both sub-syndromal and syndromal BPD (referred to as 'clients') and their (ii) family and friends (referred to as carers).

Carer participants will: (i) be relatives, legal guardians, or friends of a current Helping Young People Early (HYPE) client; (ii) be aged 18 years or older; (iii) be able to read and converse in English; and (iv) have a minimum of weekly contact with the identified client.

Client participants will be: (i) currently registered for care with the HYPE clinical program; and (ii) able to read and converse in English.

The information on the rest of this registration refers to the carers, the primary participants of interest in this trial.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Carer participants will be excluded if: (i) they are involved in current legal action against the identified client; (ii) the identified client is receiving treatment from another program at Orygen Youth Health (e.g., the Early Psychosis Prevention and Intervention Clinic); (iii) they don't have access to the internet or an appropriate computer/tablet device.

There are no exclusion criteria pertaining to client participants.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. All carer participants receive the Kindred intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation is not applicable. All carer participants receive the Kindred intervention.
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)
Safety/efficacy
Statistical methods / analysis
Data analysis of the quantitative data will consist of simple frequency counts which will be compared with the a priori safety and acceptability thresholds in order to determine success of the pilot.

In relation to the data collected within the semi-structured interviews, the quantitative variables will be aggregated into simple descriptive statistics in order to characterize the experiences of the users. In relation to the qualitative data, we will transcribe, code and summarise responses into themes for analysis.

The semi-structured one-on-one interviews have been chosen to discover participants' opinion of using Kindred. Because there are no a priori hypotheses guiding the user's experience of the site, the research uses grounded methods and has been guided by accepted theory building methods (Neuman, 2000). Using this approach, concepts are developed and modified until a theory emerges. This approach accords with Eisenhardt's eight-step roadmap for generating theory from case studies (Alvarez-Jimenez et al, 2011).

Using the audio-recorded material, three coding cycles will be undertaken as suggested in accepted coding approaches (Cotton et al, 2011; Hetrick et al, 2010) and the data will be marked up using the software "Nvivo". The open and axial coding cycles will be used to induce propositional statements.

In addition, descriptive statistics will be utilised in relation to the questionnaire items to calculate means and frequencies as appropriate to the items.

In relation to the secondary outcomes, repeated measures ANOVA will be used to compare baseline and follow-up scores on secondary outcome measures.

EMA data (at baseline and follow-up) will be analysed using multilevel regression to account for nesting of occasions (i.e., EMA surveys) within participants. Baseline and follow-up data will be combined and dummy/effect coding will be used to compare mean levels of EMA variables at baseline versus follow-up. A similar approach will be used to test whether within-person associations between EMA variables (e.g., the within-person association between interaction with the young person receiving care and carer's momentary stress) change from baseline to follow-up. Due to the small sample size, cross-level interactions will not be tested statistically, but may be explored informally.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 22003 0
3052 - Parkville
Recruitment postcode(s) [2] 22004 0
3020 - Sunshine
Recruitment postcode(s) [3] 22005 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 298841 0
University
Name [1] 298841 0
Australian Catholic University Research Fund
Address [1] 298841 0
115 Victoria Parade
Fitzroy
VICTORIA 3065
Country [1] 298841 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence in Youth Mental Health
Address
35 Poplar Rd (Locked Bag 10)
Parkville
VICTORIA 3052
Country
Australia
Secondary sponsor category [1] 298136 0
None
Name [1] 298136 0
Address [1] 298136 0
Country [1] 298136 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299783 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 299783 0
Office for Research
Level 2
South West
300 Grattan St
Parkville
VICTORIA 3052
Ethics committee country [1] 299783 0
Australia
Date submitted for ethics approval [1] 299783 0
12/07/2017
Approval date [1] 299783 0
09/11/2017
Ethics approval number [1] 299783 0
HREC/17/MH/254

Summary
Brief summary
This study is a single group, pre- and post-follow-up pilot trial that aims to evaluate the acceptability and safety of an innovative moderated online social therapy (MOST) intervention called Kindred, designed to support carers of young people who are receiving treatment for borderline personality disorder (BPD) pathology within a specialist early intervention service for youth. Kindred comprises three highly integrated functions within one web-based application. These include: (1) online psychoeducation and interactive therapy (divided into specific thematic pathways which are further separated into individual "steps"); (2) expert moderated social networking (via a "cafe"); and, (3) peer moderation. Acceptability and safety will be assessed by patterns of use of the Kindred intervention along with an interview with carers and a questionnaire, the Post-Study Usability Questionnaire (PSSUQ).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81554 0
Prof John Gleeson
Address 81554 0
School of Psychology
Australian Catholic University
115 Victoria Parade
Fitzroy
VICTORIA 3065
Country 81554 0
Australia
Phone 81554 0
+61 3 9953 3108
Fax 81554 0
Email 81554 0
john.gleeson@acu.edu.au
Contact person for public queries
Name 81555 0
Prof John Gleeson
Address 81555 0
School of Psychology
Australian Catholic University
115 Victoria Parade
Fitzroy
VICTORIA 3065
Country 81555 0
Australia
Phone 81555 0
+61 3 9953 3108
Fax 81555 0
Email 81555 0
john.gleeson@acu.edu.au
Contact person for scientific queries
Name 81556 0
Prof John Gleeson
Address 81556 0
School of Psychology
Australian Catholic University
115 Victoria Parade
Fitzroy
VICTORIA 3065
Country 81556 0
Australia
Phone 81556 0
+61 3 9953 3108
Fax 81556 0
Email 81556 0
john.gleeson@acu.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?
All of the individual trial-related participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication and for a further 3 years.
Available to whom?
Investigators whose proposed use of the data has been approved by an independent review committee.
Available for what types of analyses?
To achieve aims in the approved protocol.
How or where can data be obtained?
Initial contact should be directed to an Executive Officer at Orygen, The National Centre of Excellence in Youth Mental Health main office, located in Parkville, Australia. Phone +61 (0)3 9966 9574 or via https://www.orygen.org.au/contact/contact-us#ContactForm. Note: To gain access data requestors will need to sign a data access agreement.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 1169 0
Study protocol
Citation [1] 1169 0
Link [1] 1169 0
Email [1] 1169 0
Other [1] 1169 0
Our study protocol is available on request by contacting:
Professor John Gleeson, John.gleeson@acu.edu.au
Attachment [1] 1169 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