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Trial registered on ANZCTR


Registration number
ACTRN12616000518460
Ethics application status
Approved
Date submitted
22/03/2016
Date registered
21/04/2016
Date last updated
9/09/2019
Date data sharing statement initially provided
9/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical Trial of Group counselling and support online using Kids Helpline Circles on a secure social network.
Scientific title
Efficacy Trial of Kids Helpline Circles: A Secure Online Social Network for Young People
Secondary ID [1] 288820 0
Nil Known
Universal Trial Number (UTN)
U1111-1181-1390
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 298091 0
anxiety 298092 0
stress 298093 0
Condition category
Condition code
Mental Health 298256 298256 0 0
Depression
Mental Health 298257 298257 0 0
Anxiety
Mental Health 298258 298258 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention brief name: Group Solution Focused Counselling via Social Network + One-on-one solution focused counselling.

Control: One-on-one solution focused counselling.

For each intervention: Informational materials are provided to clients that relate to their mental health concern (e.g. depression, anxiety and stress). This is the psycho-education stage upon entrance to the trial, that is provided in both one-on-one online counselling and in group counselling via the social network. Each week that a client voluntarily attends the intervention they will be provided with more support materials from written information, short YouTube videos on how to cope with mental illness and support counselling provided by a dedicated professionally trained counsellor at Kids Helpline. In all cases, only the professionally trained and accredited counsellor at Kids Helpline will provide the intervention counselling and support material. Each professional counsellor has a minimum of 2 years experience with delivering solution focused counselling by telephone or online. For this clinical trial, the mode of delivery will be a combination of online counselling (social network group counselling) and telephone or email support (one-on-one solution focused counselling. The number of times the intervention will be delivered is determined by the volunteer participant, but they can access the intervention for up to 4 years and may do so at their own frequency in any 24 hour period. The location where the intervention occurs is only online or via telephone or email.

For all trials the intervention is the same in the experimental condition - the provision of solution focused group counselling via social network, in addition to volunteer participants also attending individual, one-on-one solution focused counselling provided by telephone and/or email. Intervention adherence is completely determined by the volunteer participant as it is important they feel the service being provided is not enforced and is a choice for them to participate with.

Counselling Schedule: Counselling sessions in both conditions are available at 24/7 and are not scheduled. Kids Helpline is a 24/7 online and telephone counselling service, Given this, scheduled appointments are not necessary or required for the intervention.

Activities in Group Counselling: Each group counselling session follows the format of solution focused counselling. This form of counselling asks the group to set a topic/goal to discuss as a group and then problem solve the issues raised in the session (e.g. how to overcome self-esteem issues, bullying, loneliness, mood swings, aggression, etc). During the session the counsellor directs the group to helpful information (e.g. mental health self-help approaches, self-care, local, regional and urban services for mental health) and asks them to share their thoughts on what they learn about these resources and rate how helpful they maybe in tackling their individual problems. The session/discussion usually closes with 'homework' for the group, asking group members to bring more information they find that helps them cope with their concerns to the next group session, regardless of what time or day they may choose to return. This allows subjects to interact and share their experiences of coping and problem based solution focused skills to the next group session they attend.

The Social Networks being used for group counselling are purpose built, privately owned and operated, social network platforms called ELGG. https://elgg.org/ and HumHub https://www.humhub.org/en (the later being introduced to the trial in April 2018). These two social networks will be used to compare online group counselling environments and user experiences, across both PC, tablet and smart phone platforms. These custom built, secure and private social network platforms can only be accessed by Kids Helpline clients invited to join. Before joining their details are recorded for counsellors to monitor client/subject engagement and adherence to the group counselling environment.

Monitoring of adherence is done through a number of means: i) log on frequency ii) downloaded content of mental health resources iii) comment posting and engagement one-on-one or in group with specific Kids Helpline counselors who monitor client/subject progress in the online environment.

'Sessions' are defined as approximately 5 min counsellor initiated discussions. Approximately, every 5 min the counsellor overseeing a group online will initiate solution focused topics to stimulate conversation and interest in the groups. These topics typically relate to what has been discussed in the previous 5 min. If the group is motivated in discussion, the counsellor will only watch the discussion and add comment if necessary. If the conversation is requires further in-put the counsellor will do so by promoting a positive and helpful prompting of discussion. This allows the group to remain free flowing for a period of time and also allows free access 24/7 to the group being monitored by the counsellor. A session can only be conducted with more than 2 participants present, but if only one participant is present the counsellor will engage them in one-on-one counselling until other participants join the discussion.
Intervention code [1] 294272 0
Behaviour
Intervention code [2] 294299 0
Treatment: Other
Comparator / control treatment
The control intervention is determined by the participant as contact to Kids Helpline offers entrance choices through telephone or email.

Control duration is as long as the volunteer client wishes to engage - a minimum of 2 weeks up to 4 years. It is important the study determines natural attrition rates to the control (i.e. existing service offering) and to the intervention (i.e. adjunct service being trialed to supplement and enhance existing service offering).

For the control intervention: Counsellors talke one-on-one with the client about their problem of inquiry. Informational materials are provided to clients via verbal reference or online links that relate to their mental health concern (e.g. depression, anxiety and stress). Each week that a client voluntarily attends one-on-one online or telephone counselling they may be provided with more support materials and ongoing support counselling provided by a dedicated professionally trained counsellor at Kids Helpline. In all cases, only the professionally trained and accredited counsellor at Kids Helpline will provide the intervention control condition counselling and support material. Each professional counsellor has a minimum of 2 years experience with delivering solution focused counselling by telephone or online. For this clinical trial the control intervention will be at the volunteer participants preference for either telephone or email support. The number of times the control intervention will be delivered is determined by the volunteer participant, but they can access the intervention for up to 4 years and may do so at their own frequency in any 24 hour period. The location where the intervention occurs is only online or via telephone or email.

For all trials the control intervention is the same for all volunteer participants - the provision of solution focused counselling via telephone or email.. Control intervention adherence is completely determined by the volunteer participant as it is important they feel the service being provided is not enforced and is a choice for them to participate with.

Counselling Schedule: Counselling sessions in both conditions are available at 24/7 and are not scheduled. Kids Helpline is a 24/7 online and telephone counselling service, Given this, scheduled appointments are not necessary or required for the intervention.

Monitoring of adherence is done through a number of means: i) log on frequency ii) downloaded content of mental health resources iii) comment posting and engagement one-on-one or in group with specific Kids Helpline counselors who monitor client/subject progress in the online environment.
Control group
Active

Outcomes
Primary outcome [1] 297742 0
Center for Epidemiological Studies
Depression Scale for Children (CES-DC)
Timepoint [1] 297742 0
administered at entry and re-administered every 2 weeks for the duration of participation in the study (minimum 2 weeks up to 4 years).
Primary outcome [2] 297743 0
The Revised Children’s Manifest Anxiety Scale (RCMAS)
Timepoint [2] 297743 0
administered at entry and re-administered every 2 weeks for the duration of participation in the study (minimum 2 weeks up to 4 years).
Primary outcome [3] 297744 0
Rosenberg Self-Esteem Scale
Timepoint [3] 297744 0
administered at entry and re-administered every 2 weeks for the duration of participation in the study (minimum 2 weeks up to 4 years).
Secondary outcome [1] 322117 0
The Multidimensional Scale of Perceived Social Support
Timepoint [1] 322117 0
administered at entry and re-administered every 2 weeks for the duration of participation in the study (minimum 2 weeks up to 4 years).

Eligibility
Key inclusion criteria
Any client who contacts Kids Helpline for counselling is eligible, regardless of whether they are experiencing depression, anxiety or stress. All clients are informed about the study and are self-selected to voluntarily participate as a member for small group counselling via a secure social network owned by Kids Helpline (n=10 p/group). All clients are free to leave the study at anytime without penalty or prejudice.
Minimum age
13 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those clients upon entry to the study, or during the study, are assessed as being in great distress (e.g. suicidal thoughts) or require immediate medical or psychiatric help.

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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A new sample size was approved by the Human Research Ethics Committee of The University of Sydney for N=400 recruited between 2019-2023. (Ethics clearance No. 2016/132). This will provide for levels of predicted attrition with young people not completing survey measures for the project and maintain an acceptable level of power for analysis of the psychometric batteries across age groups.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/04/2016
Actual
23/03/2017
Date of last participant enrolment
Anticipated
31/12/2023
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
105
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 293177 0
Charities/Societies/Foundations
Name [1] 293177 0
Yourtown - Kids Helpline
Country [1] 293177 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
Faculty of Medicine & Health
CAMPERDOWN NSW 2006
Country
Australia
Secondary sponsor category [1] 291971 0
Charities/Societies/Foundations
Name [1] 291971 0
Yourtown - Kids Helpline
Address [1] 291971 0
Yourtown - Kids Helpline
Suite 5, Cordova Street
MILTON, QLD 4064
Country [1] 291971 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294669 0
The University of Sydney
Ethics committee address [1] 294669 0
Ethics committee country [1] 294669 0
Australia
Date submitted for ethics approval [1] 294669 0
18/01/2016
Approval date [1] 294669 0
21/03/2016
Ethics approval number [1] 294669 0
HREC 2016/132

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 815 815 0 0
/AnzctrAttachments/370381-HEAppCatACond2016-132 (002).pdf (Ethics approval)

Contacts
Principal investigator
Name 64582 0
Dr Andrew Campbell
Address 64582 0
Faculty of Medicine & Health
The University of Sydney
CAMPERDOWN NSW 2006
Country 64582 0
Australia
Phone 64582 0
+61415280495
Fax 64582 0
Email 64582 0
[email protected]
Contact person for public queries
Name 64583 0
Andrew Campbell
Address 64583 0
Faculty of Medicine & Health
The University of Sydney
CAMPERDOWN NSW 2006
Country 64583 0
Australia
Phone 64583 0
+61415280495
Fax 64583 0
Email 64583 0
[email protected]
Contact person for scientific queries
Name 64584 0
Andrew Campbell
Address 64584 0
Faculty of Medicine & Health
The University of Sydney
CAMPERDOWN NSW 2006
Country 64584 0
Australia
Phone 64584 0
+61415280495
Fax 64584 0
Email 64584 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
Data collected should not be shared or identified as the participants are largely under the age of 18 and specifically entered the study. Moreover, line-by-line data would not be appropriate to analyse given the survey's undertaken are batteries of psychometrics, thus an individual data point should not be analysed given that it would invalidate the psychometric properties of the standardised measures.


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
SourceTitleYear of PublicationDOI
EmbaseA Customized Social Network Platform (Kids Helpline Circles) for Delivering Group Counseling to Young People Experiencing Family Discord That Impacts Their Well-Being: Exploratory Study.2019https://dx.doi.org/10.2196/16176
N.B. These documents automatically identified may not have been verified by the study sponsor.