Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000933651
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
29/08/2023
Date last updated
9/08/2024
Date data sharing statement initially provided
29/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effectiveness of an online gatekeeper resource for parents and caregivers to support their child’s mental health.
Scientific title
A randomised controlled trial to assess the effect of an online gatekeeper resource on parent/caregiver self-efficacy to recognise, respond and support their child's mental health and suicide risk.
Secondary ID [1] 309365 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicide prevention 331052 0
Anxiety prevention 331053 0
Depression prevention 331054 0
Self-harm prevention 331055 0
Condition category
Condition code
Mental Health 327844 327844 0 0
Suicide
Mental Health 327845 327845 0 0
Anxiety
Mental Health 327846 327846 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Recognise, Respond and Support – A Parent’s Guide to Youth Mental Health is a newly developed digital mental health and suicide gatekeeper resource, which was designed to assist parents and caregivers to support their child’s mental health. This interactive digital resource is targeted to parents and caregivers of young people aged 5-17 years and provides evidence-based information, lived experience perspectives and help-seeking guidance and resources. Taking between 60 and 90 minutes to complete, the resource consists of three key components: Recognise, Respond and Support. Users can choose to complete the resource over one or multiple sittings during a 4-week period.

The Recognise section aims to provide parents and caregivers with the knowledge to recognise mental health problems or suicide risk in their child and assist them in identifying when external professional help may be needed. This component of the resource begins with a brief introduction to mental health, the well to unwell mental health continuum and potential risk factors for poor mental health. Specific information is then provided on anxiety, depression, self-harm and suicide, the presentation of these conditions in children and adolescents, and how to identify when help may be needed.

The Respond component is designed to provide parents and caregivers with guidance on what to do if they have concerns about their child’s mental health and how to respond to a disclosure of suicide or psychological distress. This section provides information and strategies on preparing for and initiating a conversation with their child, including tips from young people, what to do if the young person doesn’t want to talk, specific guidance on asking about and responding to disclosures of self-harm and suicide, and safety planning.

The Support component of the resource aims to provide parents with information and step-by-step guidance on accessing professional help and support for their child’s mental health and what to do in a crisis situation. This section of the resource begins with an acknowledgement of common reactions parents and caregivers may experience upon learning of mental health difficulties in their child. Information on key mental health professionals is provided, as well as guidance on accessing support from the child’s school and strategies to create a supportive home environment that facilitates open discussions about mental health. The importance of looking after self while managing child mental health difficulties is also emphasised.

Downloadable information sheets (summarising key information presented in the resource) are available throughout the resource and direct links to these are provided at its conclusion. The resource was designed in consultation with parents and caregivers to ensure it met their needs and is only currently available to trial participants. Resource backend data will be used to assess intervention adherence, as well as self-reported use of the resource.
Intervention code [1] 326727 0
Prevention
Intervention code [2] 326821 0
Behaviour
Comparator / control treatment
Wait-list control. The wait-list control condition will be offered the Recognise, Respond and Support - A Parent's Guide to Youth Mental Health resource at the conclusion of the trial (after the 12-week follow-up survey).
Control group
Active

Outcomes
Primary outcome [1] 335695 0
Changes in self-efficacy to recognise, respond, and access support for mental health problems in their child.

5-item bespoke measure adapted from the Parent Self-Efficacy Scale and Confidence in Helping Scale.
Timepoint [1] 335695 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention; primary timepoint) and 12-week follow-up.
Primary outcome [2] 335696 0
Changes in self-efficacy to recognise, respond, and access support for self-harm or suicide risk in their child.

5-item bespoke measure adapted from the Parent Self-Efficacy Scale and Confidence in Helping Scale.
Timepoint [2] 335696 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention; primary timepoint) and 12-week follow-up.
Secondary outcome [1] 425225 0
Changes in perceived gatekeeper knowledge.

15-item bespoke measure adapted from the Question, Persuade, Refer (QPR) self-evaluation of knowledge questions.
Timepoint [1] 425225 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [2] 425227 0
Changes in anxiety literacy

4-items from the Anxiety Literacy Questionnaire (A-Lit)
Timepoint [2] 425227 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [3] 425228 0
Changes in depression literacy

4-items from the Depression Literacy Questionnaire (D-Lit)
Timepoint [3] 425228 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [4] 425229 0
Change in suicide literacy

4-items for the Literacy of Suicide Scale (LOSS)
Timepoint [4] 425229 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [5] 425230 0
Changes in knowledge of child and adolescent mental health

7-item Parent Knowledge of Depression and Suicide scale.
Timepoint [5] 425230 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [6] 425231 0
Changes in mental health stigma

Adapted version of the 10-item Generalised Anxiety Stigma Scale (GASS) replacing 'anxiety disorder' with 'mental health problem'.
Timepoint [6] 425231 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [7] 425232 0
Changes in suicide stigma

12-item Stigma of Suicide Scale (SOSS)
Timepoint [7] 425232 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [8] 425234 0
Changes in help-seeking attitudes

Modified 10-item Attitude Toward Seeking Psychological Professional Help Scale – Short form (ATSPPH-SF)
Timepoint [8] 425234 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [9] 425235 0
Changes in help-seeking barriers

Bespoke 11-item measure based on Barriers to Access to Care Evaluation (BACE)
Timepoint [9] 425235 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [10] 425236 0
Changes in help-seeking intentions for child personal and emotional problems

13-item General Help-seeking Questionnaire (GHSQ)
Timepoint [10] 425236 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [11] 425238 0
Changes in participant psychological distress

5-item Distress Questionnaire 5 (DQ5)
Timepoint [11] 425238 0
Pre-intervention, post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [12] 425239 0
Resource satisfaction and acceptability

A survey designed specifically for this study will be used to assess resource satisfaction and acceptability.

Semi-structured interviews will also be conducted to further explore resource experiences, as well as idenitfy the most/least helpful sections of the resource and possible changes/additions to the resource. Interviews will be conducted by a member of the research team, will take approximately 30-60 minutes to complete and will be audio-recorded for later transcription and analysis.
Timepoint [12] 425239 0
Post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.
Secondary outcome [13] 425787 0
Resource engagement

Resource website analytics and a survey designed specifically for this study to assess resource use and barriers to use.
Timepoint [13] 425787 0
Post-intervention (4-weeks after receiving access to the intervention) and 12-week follow-up.

Eligibility
Key inclusion criteria
Participation is open to all Australian residents aged 18 years old and over who are a parent or caregiver of a child aged 5-17 years. Participants are required to have sufficient English literacy skills and access to a computer, smart phone, or tablet in order to complete the training and surveys.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No exclusion criteria.

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)
Individuals are randomly allocated to the intervention or wait-list control condition by an independent statistician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation according to gender and child mental health history using a computerised randomisation table.
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
Calculation of the required sample size was based on detecting a moderate post-intervention effect size (d = 0.4) for change in self-efficacy between the intervention and wait-list control condition. Power was set at 0.9, a = .05 (two-tailed), and correlation of 0.5 assumed between pre-intervention and endpoint scores. Accommodating a 30% attrition rate, the target sample size is 380 participants (190 per condition).

Statistical analysis of continuous measures will be undertaken on an intent-to-treat basis, including all participants randomised regardless of intervention completion or withdrawal from the study. Mixed-model repeated-measures (MMRM) ANOVA will be used, with measurement occasion as a within-groups factors and condition as a between-groups factors. For any dichotomous outcomes, a comparable binary mixed modelling approach will be used. Cohen’s d effect sizes will be calculated for each timepoint.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
21/09/2023
Date of last participant enrolment
Anticipated
27/09/2024
Actual
Date of last data collection
Anticipated
27/12/2024
Actual
Sample size
Target
380
Accrual to date
350
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313563 0
Government body
Name [1] 313563 0
National Health and Medical Research Council
Country [1] 313563 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
The Australian National University, Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 316491 0
None
Name [1] 316491 0
Address [1] 316491 0
Country [1] 316491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312742 0
The Australian National University Human Research Ethics Committee
Ethics committee address [1] 312742 0
Ethics committee country [1] 312742 0
Australia
Date submitted for ethics approval [1] 312742 0
Approval date [1] 312742 0
27/06/2023
Ethics approval number [1] 312742 0
2023/195

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

Contacts
Principal investigator
Name 125746 0
Prof Alison Calear
Address 125746 0
63 Eggleston Road, The Australian National University, ACT 2601
Country 125746 0
Australia
Phone 125746 0
+61 2 6125 8406
Fax 125746 0
Email 125746 0
[email protected]
Contact person for public queries
Name 125747 0
Alison Calear
Address 125747 0
63 Eggleston Road, The Australian National University, ACT 2601
Country 125747 0
Australia
Phone 125747 0
+61 2 6125 8406
Fax 125747 0
Email 125747 0
[email protected]
Contact person for scientific queries
Name 125748 0
Alison Calear
Address 125748 0
63 Eggleston Road, The Australian National University, ACT 2601
Country 125748 0
Australia
Phone 125748 0
+61 2 6125 8406
Fax 125748 0
Email 125748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
We do not intend to make the line by line data public. However, deidentified data will be shared upon reasonable request to the Principal Investigator. Data shared will be limited to individual participant data of primary and secondary outcomes, and general demographic information.
When will data be available (start and end dates)?
Requests for data may be considered by the Principal Investigator after the publication of the main results. Data will be archived for future use with no end date specified.
Available to whom?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
Available for what types of analyses?
Requests for access to data and for each purpose, will be on a case-by-case basis by the Principal Investigator.
How or where can data be obtained?
Access to data will be subject to approval by Principal Investigator (Prof Alison Calear, contact email: [email protected])


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
No additional documents have been identified.