Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001166460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
2/10/2025
Date registered
Help: Date registered
24/10/2025
Date last updated
Help: Date last updated
15/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/10/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
While We Wait: Finding hope and support for adolescents waiting for mental health treatment
Scientific title
A pilot trial of the feasibility, acceptability, and preliminary psychological benefits and safety of the While We Wait service for adolescents waiting for mental health treatment
Additional trial identifiers [1] 314848 0
None
Universal Trial Number (UTN)
U1111-1330-0674
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psychological Distress 338116 0
Mental Wellbeing 339092 0
Perceived Control 339093 0
Perceived Hopelessness 339094 0
Condition category
Condition code
Mental Health 335372 335372 0 0
Other mental health disorders
Public Health 335539 335539 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This pilot clinical trial aims to investigate the feasibility, acceptability, and preliminary benefits and safety of a new service model (called While We Wait) for addressing the psychological needs of Australian adolescents (aged 14 to 17 years) during the wait time for mental health treatment as referred by their General Practitioner (GP). The interventions administered throughout the study are as follows:

For GPs:
• GP online training module and pre-service (i.e., baseline) procedures: After expressing their interest in the study by responding to the study advertisements in the GP recruitment period (up to 3 months), GPs who satisfy the inclusion criteria will be contacted by the research team (by email and/or telephone) and provided copies of the study information (including the GP Participant Information Sheet and Consent Form, the Adolescent Participant Information and Consent Form, and a sample copy of the GP Report). At this time, GPs will be invited to complete a one-hour live or pre-recorded webinar (dependent on their scheduling) that offers information on how to support adolescent patients on the waitlist for psychological treatment. This will be delivered by co-investigator who is a GP, training facilitator, and primary care academic. The webinar will also include an introduction to the While We Wait service model, what it offers, and how it works, which will be delivered by a member of the research team. GPs who agree will be sent a personal link to the webinar, which enables individual tracking. Within no more than 7 days of completing the webinar, the research team will contact the GPs by email and telephone to confirm their understanding of the study and finalise their consent to participate in the study. At this time, GPs will also complete the baseline study assessment, which consists of an online survey of self report measures, taking approximately 10 minutes. Within a minimum of three days after providing their consent and the baseline, GPs will be given access to their referral link, which will enable them to begin referring their adolescent patients into the study.

• A self-reported psycho-social assessment for each of their participating adolescent patients: Adolesent patients who are referred into the service and consent to take part will have their responses to a set of the self-reported mental health measures completed in the adolescent's baseline assessment (Need for Other Supports - GP Users Perceived Needs Inventory; Suicidal Ideation Attributes Scale; Single item Non-Suicidal Self-injury Screener; Weight Concerns Scale) extracted using software by the research team to form a psycho-social report. This individual report will be returned to the adolescent's participating GP via HealthLink - a secure messaging service. This report is designed to help GPs determine whether their adolescent patient has been referred to an appropriate mental health service. The report consists of a 1-page summary of the participating adolescent participant's scores for suicide risk, self-harm, eating disorders, and any additional psychosocial support that is needed. The report also includes an appendix of resources for the GP about how to respond to this information, which were collated from pre-existing Australian-based resources. A summary of the report is also emailed directly from the survey platform to each adolescent participant for their records. This report is delivered to the GPs once for each participating adolescent, sent after the adolescent has completed their baseline assessment.

For adolescent participants:
• Pre-service and baseline procedure: Adolescents will be informed about the study by their participating GP in their mental health appointment. Eligible adolescents who agree to having their contact information shared with the research team will be sent a text message with a link to the study information by the research team within three days of expressing interest. The link will contain the Adolescent Participant Information and Consent Form. Upon completion of this (within 7 days or otherwise withdrawn), the adolescent's parent or guardian will then be sent (by the research team) a link to the Parent Participant Information Sheet and Consent Form. Once this is completed (within 7 days or otherwise withdrawn), the adolescent will receive another text message from the research team, which contains a link to the self-report baseline assessment. The baseline assessment contains a battery of self-report questionnaires and takes approximately 30 minutes to complete. It can be completed on any internet device and adolescents will have up to 7 days to complete the assessment before being withdrawn from the study. Adolescents will begin receiving the While We Wait service components from completion of the baseline assessment.

The While We Wait service is a complex intervention consisting of subcomponents that are delivered to adolescent participants over a period of three months. The intervention subcomponents of the service include:

• Their self-report psycho-social assessment: Adolesent patients who are referred into the service and consent to take part will have their responses to a set of the self-reported mental health measures completed in the adolescent's baseline assessment (Need for Other Supports - GP Users Perceived Needs Inventory; Suicidal Ideation Attributes Scale; Single item Non-Suicidal Self-injury Screener; Weight Concerns Scale) extracted using software by the research team to form a psycho-social report. This individual report will be returned to the adolescent's participating GP via HealthLink - a secure messaging service. This report is designed to help GPs determine whether their adolescent patient has been referred to an appropriate mental health service. The report consists of a 1-page summary of the participating adolescent participant's scores for suicide risk, self-harm, eating disorders, and any additional psychosocial support that is needed. The report also includes an appendix of resources for the GP about how to respond to this information, which were collated from pre-existing Australian-based resources. A summary of the report is also emailed directly from the survey platform to each adolescent participant for their records. This report is delivered to the GPs once for each participating adolescent, sent after the adolescent has completed their baseline assessment.

• Project YES: This is a web-based platform that contains a suite of three evidence-based Digital Single Session Interventions (D-SSI) that each focus on a proven psychological strategy, including the Growth Mindset (Project Personality), Behavioural Activation (The ABC Project ), and Self-care and Kindness (Project CARE). Each D-SSI includes psychoeducation, scientific explanations, and peer stories; empowers adolescents by encouraging them to offer advice to others; and encourages participation in guided writing activities. All of the D-SSIs included in Project YES have been evaluated in trials conducted by other research groups with more information available in the protocol. Each D-SSI is designed to be completed in a single sitting in under 30 minutes. In the current trial, the While We Wait service encourages (through written instructions) that the adolescent participants complete the D-SSI focused on the growth mindset (Project Personality). Project Personality has been embedded into wait lists and primary care in the US and UK. For this project, we adapted Project Personality to use Australian language with a reading level of Grade 7, and Australian-English voice recordings. The other D-SSIs offered (ABC Project, Project CARE) have not been adapted into an Australian version but are available to participants in this trial with the original American text and recordings. Adolescent participants are invited to complete one D-SSI of their choice immediately after their completion of the baseline assessment. Adherence will be tracked using embedded data on the Project YES website that is linked to a unique participant identifier. After completing their first selected Project YES activity, adolescent participants are informed that they can return to Project YES at any time throughout the study period to repeat the activity, or to complete the other D-SSIs. Adolescents who complete baseline will have access to Project YES for the full duration of the study (3 months).

• Small Steps: This is an evidence-based, 9-week automated SMS intervention that delivers “bite size” self-management skills, support, check-ins, and psychoeducation to adolescent participants on a pre-programmed schedule. Each week focuses on one psychological strategy, with a total of 9 strategies covered (including help-seeking, self-compassion, valued living, daily routines, behavioural activation, problem solving, cognitive restructuring, connectedness, gratitude), with an optional 2 strategies that participants’ can ‘swap out’ if they wish (relaxation, willingness). Adolescent participants receive three consecutive days of strategy-based text message content per week (e.g. Today, see how your mood changes when you do a small, rewarding or fun activity'), plus an additional day of reflective writing prompts, and a day of pre-programmed peer messages prompts. Developed in the US, we have adapted Small Steps for weekly delivery to young Australian adolescents on wait lists in partnership with Youth with Lived Experience. This entirely automated intervention is delivered using a custom-built software platform (Audacious Software) located in Australia, with Twilio text message integration. Communication will be two-way as participants will be prompted to respond to the text messages they receive (e.g. 'Text back the activity you are planning'). However, all of the messages sent by the program (e.g. 'Thank you for sharing') are pre-programmed and any replies from participants are not monitored by the research team. Participants are able to pause or adjust the messages by replying to the pre-programmed text messages. For example 'Do you want to see more content like this in the future? Reply yes or no'. Adherence will be tracked using embedded data on Audacious Software that is linked to a unique participant identifier. Small Steps will commence for adolescent participants on the first Monday following their baseline completion to ensure that the pre-programmed content is delivered and received on weekdays (5 days content), with breaks in content over the weekend (2 days break).
Intervention code [1] 331453 0
Treatment: Other
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342103 0
Service uptake (Adolescents)
Timepoint [1] 342103 0
Assessed at conclusion of the study.
Primary outcome [2] 342104 0
Service Acceptability (Adolescents)
Timepoint [2] 342104 0
Assessed at 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Primary outcome [3] 342110 0
Psychological safety (Adolescents)
Timepoint [3] 342110 0
Assessed at 3-month post adolescent baseline (i.e. post treatment initiation)
Secondary outcome [1] 452907 0
Project YES Uptake (Adolescents)
Timepoint [1] 452907 0
Assessed at conclusion of the study.
Secondary outcome [2] 452908 0
Small Steps Uptake (Adolescents)
Timepoint [2] 452908 0
Assessed at conclusion of the study.
Secondary outcome [3] 452909 0
Project YES Acceptability (Adolescents)
Timepoint [3] 452909 0
Assessed immediately post completion of Project YES, which is anticipated to be within one week post baseline (i.e., service initiation).
Secondary outcome [4] 452910 0
Small Steps Acceptability (Adolescents)
Timepoint [4] 452910 0
Assessed at 3-weeks post Small Steps registration, which is anticipated to be 1-month post baseline (i.e. service initiation)
Secondary outcome [5] 452912 0
Barriers to service use (Adolescents)
Timepoint [5] 452912 0
Assessed at 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [6] 452913 0
Alliance with GP (Adolescents)
Timepoint [6] 452913 0
Assessed at adolescent baseline and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [7] 452914 0
Motivation for Treatment (Adolescents)
Timepoint [7] 452914 0
Assessed at adolescent baseline, 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [8] 452915 0
Treatment Uptake (Adolescents)
Timepoint [8] 452915 0
Assessed at adolescent baseline, 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [9] 452916 0
Project YES Skill Utilisation (Adolescents)
Timepoint [9] 452916 0
Assessed at 2-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [10] 452917 0
Small Steps Skill Utilisation Scale (Adolescents)
Timepoint [10] 452917 0
Assessed at 3-month post adolescent baseline (i.e., post service initiation)
Secondary outcome [11] 452918 0
Perceived Control (Adolescents)
Timepoint [11] 452918 0
Assessed at adolescent baseline, 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [12] 452919 0
Perceived Hopelessness (Adolescents)
Timepoint [12] 452919 0
Assessed at adolescent baseline, 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [13] 452920 0
Mental Wellbeing (Adolescents)
Timepoint [13] 452920 0
Assessed at adolescent baseline, 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [14] 452921 0
Adverse Events (Adolescents)
Timepoint [14] 452921 0
Assessed at 1-month, 2-month and 3-month post adolescent baseline (i.e. post service initiation)
Secondary outcome [15] 452924 0
Service uptake (GPs)
Timepoint [15] 452924 0
Assessed at conclusion of the study.
Secondary outcome [16] 452925 0
Feasibility of Service (GPs)
Timepoint [16] 452925 0
Assessed at GP baseline and at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation).
Secondary outcome [17] 452926 0
Acceptability of Service (GPs)
Timepoint [17] 452926 0
Assessed at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation).
Secondary outcome [18] 452927 0
Intervention Appropriateness (GPs)
Timepoint [18] 452927 0
Assessed at GP baseline and at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation).
Secondary outcome [19] 452928 0
Service Satisfaction (GPs)
Timepoint [19] 452928 0
Assessed at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation)
Secondary outcome [20] 452929 0
Service Feedback (GPs)
Timepoint [20] 452929 0
The first two items will be administered at GP baseline, with the remaining four items administered to GPs at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation).
Secondary outcome [21] 452930 0
Self-efficacy (GPs)
Timepoint [21] 452930 0
Assessed at pre-completion of the GP webinar training, GP baseline (i.e., pre GP service initiation), and at the conclusion of the study (3-months post GP baseline completion, i.e. post service initiation).
Secondary outcome [22] 452931 0
Service uptake (Parents)
Timepoint [22] 452931 0
Assessed at the conclusion of the study.
Secondary outcome [23] 452933 0
Service Satisfaction (Parents)
Timepoint [23] 452933 0
Assessed at 3-month post parent baseline (i.e, post service initiation)
Secondary outcome [24] 452934 0
Unexpected Effects (GPs)
Timepoint [24] 452934 0
Assessed at completion of study.

Eligibility
Key inclusion criteria
Eligible medical practicess must be: Located in the target PHN regions (CESPHN and Coordinare); Have at least 1 participating GP that treats adolescents aged 14 to 17 years with mental health problems; Have access to the digital infrastructure to support secure messaging (HealthLink); Must have a representative to complete the Medical Practice Registration Form.

GP inclusion criteria: The study is suitable for GPs who: Treat adolescents aged 14 to 17 years with mental health problems and make referrals to mental health specialists or services for these patients; Are working in a participating medical practice in the target PHN regions (CESPHN and Coordinare); Have the capacity to communicate the trial information to their adolescent patients and their families in appointments.

Adolescent inclusion criteria: Aged 14-17; Are being treated by a GP in the study; Have been referred by a participating GP for mental health treatment and assessment (e.g., to a specialist, service, or program) and are likely to experience a wait time for this; Can obtain a parent/guardian’s consent to participate; Have access to their own smartphone and the Internet; Can read English at Year 7 reading level; Are living or accessing treatment in the areas where the study is taking place (CESPHN and Coordinare); Are considered by their GP to be suitable, which means having the capacity to participate in the research study, including the ability to engage with an automated digital support service; Can attend a follow-up appointment with their GP two weeks after signing up to the study.

Parent eligibility criteria: Must be parent of participating adolescent; Can read English at Grade 7 reading level; Have an active email and/or smartphone to enable completion of study questionnaires.
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Medical practice exclusion criteria: Not located within the participating regions (CESPHN and Coordinare); Do not have the technical capabilities to receive secure messages from HealthLink; Do not complete the registration form within the recruitment period.

GP exclusion criteria: GPs will be excluded if: Their regular location of work is not within the participating regions; They do not treat adolescent patients aged 14 to 17 years; They do not make mental health treatment plans or referrals to mental health specialists and treatment providers for their adolescent patients; They are unable to offer a bulk-billed follow-up appointment within two weeks of the initial consultation for participating adolescent patients, and invoice the research team for reimbursement of any out-of-pocket (gap) payments (up to $80 per participant).

Adolescent exclusion criteria: At the time of screening, adolescents will be excluded if they: Have not been referred into the service by an enrolled GP; are unable to gain parental consent to participate (as determined by failure to return parental consent form within their recruitment period); Fail to satisfy the Gillick Competence Measure embedded in the consent form. There are no exclusions based on diagnosis, severity, or current medication use. As above, GPs are asked to consider suitability based on the young person's overall level of distress, current engagement with mental health services, and their ability to benefit from and safely engage with digital support while awaiting treatment.

Parent exclusion criteria: No exclusions apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The primary goal of the statistical analyses is to measure the feasibility of the service model, describe the acceptability of the service and describe the patterns of changes over time for mental health outcomes across the five timepoints (baseline, post-DSSI, 1M, 2M and 3M follow-up). The secondary goals of the analyses is to explore associations between baseline characteristics, feasibility measures, acceptability measures and changes in primary outcomes, to examine any differences in feasibility, acceptability and changes over time among subgroups (age, gender, GP/medical practice), and to inform power calculations for future definitive trials.

The analysis population will consist of the “Full analysis set (FAS)” defined as all participants who completed baseline and at least one follow-up assessment. The “Completer analysis” will consist of participants with data across all four timepoints (used for sensitivity analysis).

For the demographics and baseline characteristics, these will be summarised using means (SD) or medians (IQR) for continuous variables, and frequencies (%) for categorical variables. For the psychometric outcomes at each timepoint, we will report the Means and SDs and use line graphs to illustrate trends.

For handling of missing data, we will first produce a descriptive analysis of missingness patterns.

We will use descriptive statistics and estimation to quantify the preliminary benefits of the service rather than formal hypothesis testing to account for the pilot nature of the trial and insufficient power for detecting change in mental health outcomes. One model per outcome will be computed. Mixed-effects models repeated-measures analyses will be conducted in SPSS version 27.0 or Stata as required. Medical practice and GPs will be included in the analyses as a random-effects to evaluate and accommodate clustering effects. Models allow inclusion of participants with partial data and account for within-subject correlation. Confidence intervals will be used to assess the preliminary benefits and safety of the service model for adolescents and their GPs. The confidence intervals will be interpreted with regards to the minimum clinically important difference (MCID) - the degree of improvement in outcomes deemed clinically meaningful, specified by the Trial Steering Committee.

In all reporting, emphasis will be on trends, feasibility and acceptability indicators and estimation of effect sizes, not on statistical significance. All reporting will adhere to CONSORT for pilot trials.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2026
Actual
30/04/2026
Date of last participant enrolment
Anticipated
29/01/2027
Actual
Date of last data collection
Anticipated
30/04/2027
Actual
Sample size
Target
150
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319409 0
Government body
Name [1] 319409 0
National Health and Medical Research Council Medical Research Future Fund
Country [1] 319409 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 321900 0
None
Name [1] 321900 0
Address [1] 321900 0
Country [1] 321900 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317980 0
Flinders University Human Research Ethics Committee
Ethics committee address [1] 317980 0
Ethics committee country [1] 317980 0
Australia
Date submitted for ethics approval [1] 317980 0
16/06/2025
Approval date [1] 317980 0
13/10/2025
Ethics approval number [1] 317980 0

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

Contacts
Principal investigator
Name 142762 0
Prof Bridianne O'Dea
Address 142762 0
Room 348, Level 3, Social Sciences North Building, Flinders University, Sturt Road, Bedford Park, South Australia, 5042.
Country 142762 0
Australia
Phone 142762 0
+61 423366563
Fax 142762 0
Email 142762 0
[email protected]
Contact person for public queries
Name 142763 0
Bridianne O'Dea
Address 142763 0
Room 348, Level 3, Social Sciences North Building, Flinders University, Sturt Road, Bedford Park, South Australia, 5042.
Country 142763 0
Australia
Phone 142763 0
+61 423366563
Fax 142763 0
Email 142763 0
[email protected]
Contact person for scientific queries
Name 142764 0
Bridianne O'Dea
Address 142764 0
Room 348, Level 3, Social Sciences North Building, Flinders University, Sturt Road, Bedford Park, South Australia, 5042.
Country 142764 0
Australia
Phone 142764 0
+61 423366563
Fax 142764 0
Email 142764 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Researchers seeking to conduct research related to the study’s general research topic of youth mental health and digital mental health interventions will be able to seek access to the deidentified participant dataset. Researchers will be permitted to perform analyses of the data only to achieve the aims of a proposal approved by the study’s the Principal Investigator/data custodian.

When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: At publication stage of the project, the adolescent participant dataset used in the analysis will be de-identified (with all personal, location, medical practice, GP information completely removed) and then published Open Access via the Open Science Foundation using A CC-BY-NC-ND-SA license. This allows others to re-use the data, but ensures that it will be cited when they do (this is the ‘BY’ restriction). We have added additional restrictions to standard creative commons licenses, including ‘NC’ to only allow non-commercial uses, ‘ND’ to only allow exact reuse but not the creation of derivative products, and ‘SA’ to require re-uses to be licensed under the same terms. This data will remain open access indefinitely.

• Email of trial custodian, sponsor or committee: Researchers can contact the study’s Principal Investigator and data custodian, Professor Bridianne O’Dea to request access approval to the dataset. Professor Bridianne O'Dea’s contact email address is [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    While We Wait Adolescent PICF V4.pdf
Informed consent form    While We Wait Parent PICF V4.pdf
Informed consent form    GP PICF V4.pdf


Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.