Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001223628
Ethics application status
Approved
Date submitted
17/10/2014
Date registered
20/11/2014
Date last updated
4/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Link Research Project: Can a dedicated online help-seeking website increase positive affect for young adults?
Scientific title
The Link Research Project: A randomised controlled trial comparing the positive affect of an online dedicated mental health help-seeking program with usual search strategies in young adults
Secondary ID [1] 284993 0
Nil
Universal Trial Number (UTN)
U1111-1159-3324
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 292498 0
Condition category
Condition code
Mental Health 292807 292807 0 0
Depression
Mental Health 292808 292808 0 0
Addiction
Mental Health 292809 292809 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ‘What’s Up?’ website is a dedicated online service designed to facilitate help-seeking for young adults. ‘What’s Up?’ matches the user’s needs and preferences with appropriate online and offline services. The website consists of two sections: (1) the triage process and (2) recommendations.

THE TRIAGE PROCESS: Participants will sign in using a secure username and password. Then they will be triaged by their responses on (1) area of concern, (2) severity of concern and (3) preferred service modality. There are four servie modalities to choose from: 1) face-to-face options (e.g., general practitioners and headspace centres), 2) online chat services (e.g., e-headspace), 3) phone lines (e.g., lifeline) and 4) online information sites (e.g., reachout.com.au).

RECOMMENDATIONS: Based on this triage, users will be given the names of services appropriate to their needs plus an additional 'recommended' service. This latter recommendation is based on the type and severity of the issue. Users can click on each service to get detailed information outlining what to expect from the service, a successful story from a young person who has used it, and what to prepare for when accessing the service. All services will have a link to the service website, the phone number or in the case of face-to-face services, a link to a website allowing participants to find a service close to them. Many of the online services are free to access. For paid services (such as some GPs), information is provided about how much participants can expect to pay and any rebates they may be entitled to receive.

LENGTH OF INTERVENTION: The young person’s journey through the triage process and exploration of the recommendations is designed to take a minimum of 90 seconds. Some users may wish to spend longer to explore multiple issues and read the information about many different services, which will therefore take longer. Users can also return to the website at any time they wish for the duration of the trial (approximately three months) to explore different issues and different services. For the purposes of this trial, a participant will be considered to have completed the intervention if they have completed the triage process and clicked on the recommendation page at least once. The number of times participants complete or log on to the website over the three months of the trial will also be used in the analyses.
Intervention code [1] 289827 0
Prevention
Intervention code [2] 289828 0
Early detection / Screening
Comparator / control treatment
Usual help-seeking strategies will be the control condition. Participants will be asked to seek help for their issue using their usual help-seeking strategies. They may seek help however they wish, but will not have access to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 292665 0
Positive affect on the Positive and Negative Affect Schedule (Watson, 1988) immediately after intervention
Timepoint [1] 292665 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help)
Secondary outcome [1] 309449 0
Help-seeking intentions will be assessed by self-report using the Stages of Change Questionnaire (Lewis et al., 2009)
Timepoint [1] 309449 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help), 1 month and 3 months follow up
Secondary outcome [2] 309450 0
Self-reported help-seeking behaviours assessed using an online brief version of the Mental Health Care Resource Use Questionnaire (Mihalopoulos, Lee, Magnus, Shih, & Chatterton, 2014).
Timepoint [2] 309450 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help), 1 month and 3 months follow up
Secondary outcome [3] 309451 0
Mental health will be measured by self-report using the k10 (Kessler et al., 2003).
Timepoint [3] 309451 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help), 1 month and 3 months follow up
Secondary outcome [4] 309453 0
Satisfaction and trust in the service, and the likelihood of using the service in the future will be self-administered. Participants will complete the Client Satisfaction Questionnaire and asked 10 items adapted from Retolaza (2003) about whether their expectations were met.
Timepoint [4] 309453 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help), 1 month and 3 months follow up
Secondary outcome [5] 310734 0
Barriers to Adolescent's Seeking Help Scale - Brief Version (Kuhl, et al., 1997 & Wilson, Rickwood, Ciarochi & Deane, 2002) assessed at baseline, 1-month and 3-month follow ups
Timepoint [5] 310734 0
Baseline, 1 month and 3 months follow up
Secondary outcome [6] 310735 0
Negative affect on the Positive and Negative Affect Schedule (Watson, 1988)
Timepoint [6] 310735 0
From one to 14 days post-randomisation (participants are asked to complete a post-intervention survey immediately after their first attempt at seeking help), 1 month and 3 months follow up
Secondary outcome [7] 310736 0
Positive affect on the Positive and Negative Affect Schedule (Watson, 1988)
Timepoint [7] 310736 0
1 month and 3 months follow up
Secondary outcome [8] 311274 0
User experiences and process evaluation (as assessed qualitatively in interviews with between 10 and 50 participants)
Timepoint [8] 311274 0
1-month and 3 months follow up

Eligibility
Key inclusion criteria
To be included in the study, the young adults must: (1) be between 18 and 25 years of age inclusive, (2) live in Australia, (3) have two contact details such as a current valid email address and a phone number, and (4) as the program is only available in English, it is important that the participants all have sufficient English reading and writing abilities to complete the surveys and complete the Link program. As all young people could benefit from the information provided on the website regardless of mental health issues (e.g., information on bullying or relationships), participants do not need to have a mental health issue to be included in this study. Although, our pilot study indicates that 60% of participants are likely to have a moderate to severe disorder based on the k10.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-English speaking
Living outside Australia
Not between 18-25 years of age

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Each participant will be identified by an identification number (ID). This ID will be randomly allocated to either the intervention or control arms using a random seed generator. The sequence for the random allocation will be set up automatically by the computer software used (QuON) and not involve the research team directly. Participants will be allocated to a trial arm after completion of the baseline survey. Participant's will receive a pop-up webpage with their study arm. This will be attached to the participants identification number depending on randomisation allocated in order to prevent the researchers from identifying the arm the participants are allocated to. Once that person clicks the link and enters the website, they will be randomised into the program. The program developers will be independent and not involved in any data collection or analyses. A statistician not involved with the research will provide assistance and oversee the randomisation process and will release the code to the arms to the researchers once data analysis is complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used with participants stratified by gender (male, female) and distress (as measured by a cut off of 20 on the k10)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
250 young adults in each arm (a total of 500 participants) will be recruited. This sample size is based on the positive affect subscale of the PANAS with an effect size of 0.34, an alpha of 0.05, 80% power and allowing for 2/3 attrition as is likely when recruiting participants from online sources. We anticipate the a total sample size of 214 (107 in each arm) is sufficient to detect a small difference of 2.7 on the PANAS positive affect subscale. Intention-to-treat analysis will be used. Mixed methods analysis will be used to test the primary and secondary outcomes of positive and negative affect, help-seeking intentions and behaviours, mental health symptoms, as well as satisfaction and trust in the help-seeking strategies. User experiences, satisfaction and process evaluation will also be qualitatively conducted in interviews with a small number of participants.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
24/11/2014
Actual
27/11/2014
Date of last participant enrolment
Anticipated
1/07/2015
Actual
13/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
500
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 289608 0
Other Collaborative groups
Name [1] 289608 0
Young and Well Cooperative Research Centre
Country [1] 289608 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
General Practice 200 Berkeley St Carlton, VIC, 3053
Country
Australia
Secondary sponsor category [1] 288291 0
Charities/Societies/Foundations
Name [1] 288291 0
ReachOut.com by Inspire Foundation
Address [1] 288291 0
97 Church St Camperdown, NSW, 2050
Country [1] 288291 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291344 0
Health Sciences Human Ethics Sub Committee
Ethics committee address [1] 291344 0
Ethics committee country [1] 291344 0
Australia
Date submitted for ethics approval [1] 291344 0
Approval date [1] 291344 0
10/04/2014
Ethics approval number [1] 291344 0
1341063.1

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

Contacts
Principal investigator
Name 49982 0
Dr Sylvia Kauer
Address 49982 0
General Practice University of Melbourne 200 Berkeley St Carlton, VIC, 3053
Country 49982 0
Australia
Phone 49982 0
+61390356097
Fax 49982 0
Email 49982 0
[email protected]
Contact person for public queries
Name 49983 0
Sylvia Kauer
Address 49983 0
General Practice University of Melbourne 200 Berkeley St Carlton, VIC, 3053
Country 49983 0
Australia
Phone 49983 0
+61390356097
Fax 49983 0
Email 49983 0
[email protected]
Contact person for scientific queries
Name 49984 0
Sylvia Kauer
Address 49984 0
General Practice University of Melbourne 200 Berkeley St Carlton, VIC, 3053
Country 49984 0
Australia
Phone 49984 0
+61390356097
Fax 49984 0
Email 49984 0
[email protected]

No information has been provided regarding IPD availability


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
EmbaseThe Cost-Effectiveness of an Internet Intervention to Facilitate Mental Health Help-Seeking by Young Adults: Randomized Controlled Trial.2019https://dx.doi.org/10.2196/13065
N.B. These documents automatically identified may not have been verified by the study sponsor.