Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001171404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/10/2025
Date registered
Help: Date registered
28/10/2025
Date last updated
Help: Date last updated
2/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
28/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot study evaluating whether the Growing Minds Check-In for Young People (GMCI-Y) is acceptable and improves help-seeking behaviour, intentions & efficacy in adolescents
Scientific title
The Growing Minds Check-In for Young People (GMCI-Y): A pilot randomized controlled trial evaluating its acceptability and preliminary efficacy for improving help-seeking behaviour, intentions & efficacy
Additional trial identifiers [1] 315388 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Adolescent mental health 338914 0
Condition category
Condition code
Mental Health 335212 335212 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Growing Minds Check-In for Young People (GMCI-Y) is a brief, self-directed online mental health check-in and referral tool. Participants will access the GMCI-Y via secure online website built by Netfront, our IT partner and host-organisation. The GMCI-Y has been co-designed by experts and end-users (i.e., clinicians, researchers, young people, parents).

The GMCI-Y contains four primary components: 1) questions about the young person’s current mental health concerns and their impact; 2) validated measures of mental health and wellbeing symptoms (i.e., the Youth-Report Pediatric Symptom Checklist-17, Kessler Psychological Distress Scale); 3) automatically generated feedback based on their responses. This feedback will consist of a summary of their responses to subjective questions (e.g., you told us that...), and feedback on their scores on validated measures. The K10 will be scored using validated ranges indicating level of distress (low, moderate, high, very high). PSC-17-Y scores will be categorised into risk profiles for each subscale according to clinical cutoffs and a brief text summary of what their score for each subscale indicates will be given (e.g., for the internalising problems subscale, a score of 5+ suggests they may be feeling anxious stressed or down). Encouraging messaging such as "you're not alone, lots of people feel this way and support is available" will also be given to those who score above clinical cutoffs. Participants will not be given their raw scores; and 4) recommendations for support and online evidence-based programs, services, and information matched to level of need and identified areas of concern. Young people will be given 1-3 top recommendations for each concern and can select which concern they would like to see recommendations for. They will also have access to the full library of recommendations with filters (e.g., concern, cost, length, platform, self-directed or guided). All recommendations include descriptions that identify the focus, evidence supporting it, cost (if applicable), and length. Recommended online programs have been evaluated by the research team to meet minimum criteria for inclusion (at least one evaluation or research trial demonstrating the program’s effectiveness at improving mental health outcomes in adolescents). Examples of recommended programs include BRAVE, ClearlyMe, Sleep Ninja, and Chilled Out Online.
Other online resources (e.g., information, peer support platforms) were evaluated for inclusion based on credibility/reputation of the developing body, content (e.g., recency, use of evidence-based strategies), and relevance (e.g., My Circle by Kids Helpline, ReachOut, QLife).

The GMCI-Y will take approximately 15 minutes to complete in one-sitting, but participants may save their progress and complete it across multiple sittings. The intervention is self-directed and fully online, thus can be completed at a location of the participant’s choosing. Participants will be randomised to either the intervention group who will gain access to the GMCI-Y immediately or the Waitlist control group, who will gain optional access one month after completing pre-assessment questionnaires. The intervention group will be required to complete the GMCI-Y once but will have optional access to complete the GMCI-Y a second time after completing the one-month follow-up measures. This will allow us to examine how many young people choose to use the GMCI-Y again.

Young people will be prompted to save their feedback and recommendations as a PDF and share it with a trusted adult or their GP. They will also be reminded that the GMCI-Y is not designed to provide a comprehensive assessment or diagnosis and therefore may not identify issues that would be identified by a full clinical assessment conducted by a health practitioner.

Adherence to the intervention will be monitored by the number of questions completed by participants. A notification schedule will be developed so that participants who meet the following conditions will be reminded via multiple communication channels (e.g. email, SMS text message, phone call) at various times (e.g. 1-week past invitation, 2 weeks past invitation):
• Participants who complete baseline questionnaires but do not register for the GMCI-Y
• Participants who register but do not complete all GMCI-Y questions
Intervention code [1] 332017 0
Early detection / Screening
Intervention code [2] 332116 0
Prevention
Intervention code [3] 332117 0
Behaviour
Description of the comparator or control
Participants randomly allocated to the waitlist control group will wait one month before gaining optional access to the GMCI-Y intervention after completion of the one-month follow-up questions. The waitlist group will be able to access usual services and support during the waiting period.
Control group
Active

Outcomes
Primary outcome [1] 342825 0
Mental health help-seeking behaviour
Timepoint [1] 342825 0
Baseline and one-month follow-up
Primary outcome [2] 342827 0
Mental health help-seeking intentions
Timepoint [2] 342827 0
Baseline and one-month follow-up
Primary outcome [3] 342828 0
Mental health help-seeking efficacy
Timepoint [3] 342828 0
Baseline and one-month follow-up
Secondary outcome [1] 452279 0
Psychological distress
Timepoint [1] 452279 0
Baseline and one-month follow-up
Secondary outcome [2] 452280 0
Knowledge of where to access support to strengthen their mental health and wellbeing
Timepoint [2] 452280 0
Baseline, post-assessment, and one month follow-up
Secondary outcome [3] 452284 0
Conversations about mental health
Timepoint [3] 452284 0
Baseline and one-month follow-up
Secondary outcome [4] 452285 0
Cost-effectiveness
Timepoint [4] 452285 0
Baseline and one-month follow-up
Secondary outcome [5] 452286 0
Satisfaction (component of acceptability) with the GMCI-Y
Timepoint [5] 452286 0
Post-assessment
Secondary outcome [6] 452288 0
Perceived usefulness (component of acceptability) of the GMCI-Y
Timepoint [6] 452288 0
Post-assessment
Secondary outcome [7] 452289 0
Parent-child relationship quality
Timepoint [7] 452289 0
Baseline and one-month follow-up
Secondary outcome [8] 452290 0
Barriers to help-seeking
Timepoint [8] 452290 0
Baseline and one-month follow-up
Secondary outcome [9] 452788 0
Mental health and help-seeking stigma
Timepoint [9] 452788 0
Baseline and one-month follow-up
Secondary outcome [10] 452791 0
Sharing of check-in feedback
Timepoint [10] 452791 0
One-month follow-up
Secondary outcome [11] 453335 0
Psychosocial functioning (internalizing, externalizing, and attention problems)
Timepoint [11] 453335 0
Baseline and one-month follow-up
Secondary outcome [12] 463007 0
Basic psychological need satisfaction
Timepoint [12] 463007 0
Baseline and one-month follow-up

Eligibility
Key inclusion criteria
1) Aged 12 years to 17 years, 10 months; 2) Comfortable reading and completing questionnaires in English; 3) Residing in Australia; 4) Reliable access to internet. 5) Parental consent for young people under 16 years; 6) Are interested in learning more about their mental health/wellbeing.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
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)
Allocation to treatment condition will be concealed to the researchers by using a central randomisation procedure on the trial’s REDCap system. Once the participant has provided informed consent (i.e., signed the consent form) following the recruitment and screening interview, the participant will be randomized to either the online intervention (GMCI-P) or waitlist control using the in-built randomization feature on REDCap. This procedure will ensure concealment of treatment allocation as well as an audit trail for confirming allocation. Participants will then be directed to complete a group specific baseline assessment. Once participants have completed the baseline assessment, they will be notified of the allocated group via email.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple randomisation sequence will be generated using Robust Randomisation App (RRApp; Tu & Benn, 2018), which is an online tool. This sequence will be imported into the trial’s REDCap system.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A sample size calculation is not necessary for pilot/feasibility studies. However, we calculated one to ensure we have an approximate guide for recruitment. Sample size calculations using G*Power show that we will be able to detect a medium (f = 0.25) increase in continuous variable (i.e., help-seeking efficacy, help-seeking intentions, confidence talking to others about MH) from pre- to post- with a 2 (group) x 2 (time) repeated-measures ANOVA with a total complete sample size of N = 34 (n = 17 per group; power = 0.80 at alpha = 0.05). Attrition in similar studies has been around 30% (e.g. Wiljer et al., 2020). Thus, we will aim to recruit N = 49 participants to account for attrition [34/(1-0.30) = 49]. Additionally, Whitehead et al (2015) suggest that N = 40 (n = 20 for each group) is a good rule of thumb for detecting a small effect size (0.1 to < 0.3) for a trial with 80% power.
Help-seeking behaviour is a binary (yes/ no) variable, thus a Generalised Estimating Equation (GEE) with a binominal distribution is an appropriate method for analysing a 2 (group) x 2 (time) repeated measures design. This power calculation was conducted assuming that 30% of both groups are currently help-seeking, and that the control group doesn’t show change from T1 to T2. To detect an increase of 30% in help-seeking behaviour in the intervention group (n = 25) a group x time interaction OR (i.e. ratio of odds ratios) of 3.43 is estimated, which equates to a medium/large effect size (Cohen’s d) of 0.68.
Analyses will follow Consolidated Standards of Reporting Trials (CONSORT; Schulz et al., 2010) for longitudinal analyses. Statistical analyses will be conducted in SPSS. Initial comparisons of the intervention and waitlist control groups at baseline will be performed using ANOVAs and chi-square tests of independence. This is to ensure randomisation was adequate meaning no significant differences between groups on demographic variables or outcome variables prior to the intervention. This also includes chi-square tests for significant differences in rates of attrition between intervention and waitlist control group.

Primary outcomes:
1. Help-seeking intentions: Intervention effects will be measured using a linear mixed model, with group as a between-subjects factor (intervention, waitlist control) and timepoint (baseline [T1] and one-month follow-up [T2]) as a within-subjects factor. The model will also include a group × time interaction term to determine whether changes in help-seeking intentions differed as a function of the intervention condition. Effect sizes will be reported as partial eta squared and Cohen’s d for between-group differences.
2. Help-seeking behaviour: intervention effects will be measured using a logistic regression, with group as a between-subjects factor (intervention, waitlist control) and timepoint (baseline [T1] and one-month follow up [T2]) as a within-subjects factor. Differences at T1 on current help-seeking behaviour (yes/no to question: are you currently seeking or receiving help for your MH or wellbeing (this could include seeing a health professional, an online program/course or parenting program) will be used as a covariate in the analyses to control for any differences. Regressions also included an interaction term to determine whether changes in help-seeking behaviour were moderated by current help-seeking behaviour. Cohen’s d will be used to measure the effect size.
3. Help-seeking efficacy: Intervention effects will be measured using a linear mixed model, with group as a between-subjects factor (intervention, waitlist control) and timepoint (baseline [T1] and one-month follow-up [T2]) as a within-subjects factor. The model will also include a group × time interaction term to determine whether changes in help-seeking efficacy differed as a function of the intervention condition. Effect sizes will be reported as partial eta squared and Cohen’s d for between-group differences.

For secondary outcome variables, effects will be measured using repeated measures ANOVAs, with group as a between-subjects factor (intervention, waitlist control) and timepoint (baseline [T1] and one-month follow up [T2]) as a within-subjects factor. Variables that differ by group at baseline will be used as covariates in the analyses to control for any differences. Cohen’s d will be used to measure the effect.

Depending on amount of missing data, we will perform an intention-to-treat (ITT) analysis, such that participants’ data will be analysed according to the group they were originally randomly assigned to. That is, if a waitlist control participant completed the intervention during the waitlist period, they will be analysed as a control participant. If an intervention participant did not complete the intervention, they will still be analysed as an intervention group participant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2026
Actual
13/05/2026
Date of last participant enrolment
Anticipated
20/07/2026
Actual
9/07/2026
Date of last data collection
Anticipated
20/08/2026
Actual
9/09/2026
Sample size
Target
49
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 319979 0
Government body
Name [1] 319979 0
Australian Department of Health, Disability and Ageing, Medical Research Future Fund (MRFF) - Million Minds Mental Health Research Mission
Country [1] 319979 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 322537 0
None
Name [1] 322537 0
None
Address [1] 322537 0
Country [1] 322537 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318517 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 318517 0
Ethics committee country [1] 318517 0
Australia
Date submitted for ethics approval [1] 318517 0
04/09/2025
Approval date [1] 318517 0
04/11/2025
Ethics approval number [1] 318517 0

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

Contacts
Principal investigator
Name 144438 0
Prof Mark Dadds
Address 144438 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown, NSW 2050
Country 144438 0
Australia
Phone 144438 0
+61 291144326
Fax 144438 0
Email 144438 0
[email protected]
Contact person for public queries
Name 144439 0
Mark Dadds
Address 144439 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown, NSW 2050
Country 144439 0
Australia
Phone 144439 0
+61 291144326
Fax 144439 0
Email 144439 0
[email protected]
Contact person for scientific queries
Name 144440 0
Mark Dadds
Address 144440 0
The University of Sydney Child Behaviour Research Clinic Level 1, 97 Church Street, Camperdown, NSW 2050
Country 144440 0
Australia
Phone 144440 0
+61 291144326
Fax 144440 0
Email 144440 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.