Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000386639
Ethics application status
Approved
Date submitted
21/03/2014
Date registered
9/04/2014
Date last updated
4/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a dedicated online help-seeking website facilitate help-seeking for young adults? Pilot randomised controlled trial
Scientific title
Facilitating mental health help-seeking for young adults with the Link project: A pilot randomised controlled trial comparing pathways to mental health care for a web-based program and usual search strategies
Secondary ID [1] 284283 0
None
Universal Trial Number (UTN)
U1111-1154-6320
Trial acronym
Link
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 291420 0
Condition category
Condition code
Mental Health 291787 291787 0 0
Depression
Mental Health 291788 291788 0 0
Anxiety
Mental Health 291789 291789 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Link is a dedicated online web service to guide users to appropriate avenues for both online and offline sources of care.
The service will triage the user by assessing the area of concern, severity of concern and readiness to access care. For the purposes of this study, users must sign in so that their data can be stored and accessed again. Users can also return and log in to return to data that they have already entered.
Based on the triage, users will also be given detailed information about three services appropriate to their needs and wants plus an additional 'recommended' service. Information about that service including target area, triage criteria, evidence to support it and youth friendliness will be included. Each service listed will have some digital content associated with it, 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. This information can be accessed through the triage once the user reaches the recommended services page. The website should take a minimum of 90 seconds to complete (as per recommendations for developing websites and apps for young people) but users can spend longer to explore their issues and return if they wish. Participants in the intervention arm will have access to the website for the duration of the trial (1 month in total).
Intervention code [1] 288997 0
Prevention
Intervention code [2] 289111 0
Other interventions
Intervention code [3] 289112 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 and be directed to google. However, they may seek help however they wish, but will not have access to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 291711 0
Self-reported help-seeking behaviours assessed using an online version of the Mental Health Care Resource Use Questionnaire (Mihalopoulos, Lee, Magnus, Shih, & Chatterton, 2014).
Timepoint [1] 291711 0
1 month after randomisation
Primary outcome [2] 291712 0
Help-seeking intentions will be assessed by self-report using the Stages of Change Questionnaire (Lewis et al., 2009) and two items created using the ReBEQI guidelines (Francis et al., 2004) that ask agreement on a 7-Point Likert Scale, 'I want to seek help for my problems' and 'I intend to seek help for my problems'
Timepoint [2] 291712 0
1 month after randomisation
Secondary outcome [1] 307336 0
Access to appropriate care assessed by self-report and experts. Participants who indicate that they have found help using the resource use questionnaire, will complete questions asking how appropriate this source of information was for them in terms of: whether their questionnaire were answered the service helpful, the service matched the problem, and whether the service helped them understand the problem better. A panel of experts will be given data about the issues, level of distress and the types of care received, and using this data determine whether the services used were appropriate for the individual.
Timepoint [1] 307336 0
6 month
Secondary outcome [2] 307337 0
Timeliness of access to appropriate care will be assessed after determining whether the participant has reached an appropriate service. If an appropriate service is reached, the time to access will be calculated according to whether the young adult reached the service within the first 7 days or at one month.
Timepoint [2] 307337 0
Assessed once completed help-seeking strategy (either intervention or usual help-seeking strategies) from 1 to 7 days after baseline and again 1 month after baseline
Secondary outcome [3] 307338 0
Mental health will be measured by self-report using the k10 (Kessler et al., 2003) and the Mental Health Continuum - short form (Lambers, 2011).
Timepoint [3] 307338 0
1 month after randomisation
Secondary outcome [4] 307339 0
Economic evaluation will be measured using the self-report resource use and the Adolescent Quality of Life Questionnaire (Hawthorne et al., 2013),
Timepoint [4] 307339 0
1 month after randomisation
Secondary outcome [5] 307340 0
Changes in self-worth, empowerment, attitudes and self-stigma will self-reported using the Adolescent Quality of Life Scale (Hawthorne et al., 2013), the Barriers to Adolescents Seeking Help scale (Kuhl et al., 1997), 5 questions about people they know who have sought help before and their attitudes towards it, and the Mental Health Literacy Vignette (Jorm et al., 2007).
Timepoint [5] 307340 0
1 month after randomisation
Secondary outcome [6] 307341 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 [6] 307341 0
1 week after randomisation

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 three contact details such as a current valid email address (essential) and residential address (essential), and either a phone number or alternative email address, 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.
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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. A link to either google or Link 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. An academic, independent from the research team and not directly involved with the research, will provide assistance and oversee the randomisation process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation will be used.
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
Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
A small pilot study will first be conducted consisting of 80-100 young adults in each arm (a total of 200 participants, allowing for 2/3 attrition as is likely when recruiting participants from online sources) to test the feasibility of trial methods including response rate and attrition rate, suitability of measures, and progress through the intervention. This information will assist with refining the methods for the main trial and estimating the required sample size. Intention-to-treat analysis will be used with a focus on latent growth curve modelling. Mixed methods analysis will also be used to test the primary and secondary outcomes of help-seeking intentions and behaviours, appropriateness of care, timeliness of access, mental health symptoms, economic evaluation, self-worth, empowerment, attitudes and stigma, 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
25/04/2014
Actual
8/05/2014
Date of last participant enrolment
Anticipated
31/07/2014
Actual
19/08/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
311
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288910 0
Other Collaborative groups
Name [1] 288910 0
Young and Well Cooperative Research Centre
Country [1] 288910 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] 287606 0
Charities/Societies/Foundations
Name [1] 287606 0
ReachOut.com by Inspire Foundation
Address [1] 287606 0
97 Church St
Camperdown, NSW, 2050
Country [1] 287606 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290740 0
Health Sciences Human Ethics Sub Committee
Ethics committee address [1] 290740 0
Ethics committee country [1] 290740 0
Australia
Date submitted for ethics approval [1] 290740 0
31/10/2013
Approval date [1] 290740 0
10/04/2014
Ethics approval number [1] 290740 0
1341063

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

Contacts
Principal investigator
Name 47022 0
Dr Sylvia Kauer
Address 47022 0
General Practice
University of Melbourne
200 Berkeley St
Carlton, VIC, 3053
Country 47022 0
Australia
Phone 47022 0
+61390356097
Fax 47022 0
Email 47022 0
[email protected]
Contact person for public queries
Name 47023 0
Sylvia Kauer
Address 47023 0
General Practice
University of Melbourne
200 Berkeley St
Carlton, VIC, 3053
Country 47023 0
Australia
Phone 47023 0
+61390356097
Fax 47023 0
Email 47023 0
[email protected]
Contact person for scientific queries
Name 47024 0
Sylvia Kauer
Address 47024 0
General Practice
University of Melbourne
200 Berkeley St
Carlton, VIC, 3053
Country 47024 0
Australia
Phone 47024 0
+61390356097
Fax 47024 0
Email 47024 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
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