Mental HealthSOSNCT07136584
SOS for Caregiver Wellbeing
A study testing Screening, Outcomes and Referral Pathways in people with Mental Health and Depression and Burden in Caregivers, run by Murdoch Childrens Research Institute at 1 site in Australia.
Trial summary
Parents and caregivers of children who have a chronic condition carry a large care burden and are at higher risk of having mental health symptoms. This study aims to see if completion of a mental health questionnaire by parents / caregivers at or before the child's paediatric appointment can help identify any symptoms… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mental Health, Depression and Burden in Caregivers, Anxiety Depression
- What is being tested?
- Screening, Outcomes and Referral Pathways
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteAustralia
- Study dates
- 22 Oct 2025to Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- must be a parent of a child <18yo in an outpatient clinic at Royal Children's Hospital (in enrolled clinics either neuromuscular or diabetes)
- able to complete a consent form in English without an interpreter
Who cannot join
- need for an interpreter to complete informed consent
Trial locations and contacts
1 site in 1 country.
Australia1 site
Outpatient clinics - Royal Children's Hospital
Parkville, Victoria, 3052
About this study
Official title: SOS for Caregiver Wellbeing: Testing the Feasibility of a Screening, Outcomes and Support (SOS) Model for Parents and Caregivers of Children With Chronic Conditions
Parents and caregivers of children who have a chronic condition carry a large care burden and are at higher risk of having mental health symptoms. This study aims to see if completion of a mental health questionnaire by parents / caregivers at or before the child's paediatric appointment can help identify any symptoms of stress, anxiety or depression.
Following the questionnaire, parents / caregivers will be provided with the results of the questionnaire along with an information resource sheet. This will include information on anxiety, stress and depression, as well as different agencies they can contact to get support.
Read more
Parents / caregivers will be followed up at 3 and 6 months to see if they have any changes to mental health and quality of life, and whether they accessed any support services. Participants who did not complete the 3-month survey will be asked at the 6-month clinic visit to provide responses on an iPad to up to 5 questions selected from the 3-month survey. A text message will be sent prior to the visit to inform them.
The primary aim for this trial is to see whether parents / caregivers find this process acceptable, and whether it can work in a busy hospital clinic.
Read the detailed description
This single-arm prospective trial aims to evaluate the feasibility and acceptability of implementing a mental health screening and support pathway (the SOS model) for parents and caregivers of children with chronic conditions (CMs) in an outpatient clinic setting. The study will recruit 100 parents and caregivers attending the Royal Children's Hospital (RCH) outpatient clinics.
For the remainder of this protocol, all parents and caregivers will be referred to as 'caregivers.'
The primary objective is to test a systematic approach where:
- Caregivers undergo mental health screening using validated measures.
- Receive feedback on their mental health screening measure scores from their RCH clinician or a researcher
- All caregivers are provided with resources on appropriate support pathways
The support framework will include:
- Psychoeducational resources describing symptoms of anxiety, depression and stress
- Description of referral pathways to primary care physicians for mental health plans, enabling access to government-funded psychological support
- Connection to existing online mental health resources
By evaluating this approach, the trial seeks to determine the:
- acceptability of the screening process to both caregivers and clinicians
- feasibility of screening and feedback for caregivers attending their child's outpatient hospital appointment
- practicality of integrating mental health screening and feedback into routine outpatient care
- effectiveness of the referral pathways in connecting parents to appropriate support services
- barriers or facilitators to implementing this model of care The findings will inform whether this screening and support model could be implemented as part of standard care for caregivers of children with chronic conditions.
- Conditions
- Mental Health, Depression and Burden in Caregivers, Anxiety Depression, Stress, Caregiver Anxiety, Parent of Child With Chronic Life-threatening Illness
- Being tested
- Screening, Outcomes and Referral Pathways
- Keywords
- parent, caregiver, chronic illness, screening, mental health, anxiety, depression, stress, referral pathways
- Medical subject headings
- Psychological Well-Being, Depression, Chronic Disease, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening, Outcomes and Referral PathwaysOther
All participants complete baseline screening with follow up at 3 and 6 months. A key feature of the study is that a standardised information resource sheet (to community-based services) is provided to all caregivers, regardless of their screening scores. Primary outcomes focus on implementation feasibility and acceptability, while secondary outcomes examine service uptake and longitudinal measurement of caregiver wellbeing.
This differs from existing research by providing resources universally rather than only to those scoring above clinical thresholds. Our longitudinal follow-up addresses an evidence gap identified in our systematic review - limited published data on downstream effects on actual service uptake and mental health outcomes over time. The services in the resource sheet also link to routine clinical care that doesn't require specialist support programs with dedicated funding.
| Study group | Role | What they receive |
|---|---|---|
| Screening outcome - information resource sheet | Other | Arm Description
* This is a single-arm prospective feasibility trial
* Every consenting caregiver is screened with a mental health screening questionnaire - the Depression, Anxiety, and Stress Scale (DASS-21)
* They will be provided feedback on their results
* Regardless of the results, all participants will be provided an information resource sheet will that provides descriptions of common mental health conditions, details on how to access psychology support services and links to existing online mental health resources. Receives: Other: Screening, Outcomes and Referral Pathways |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the overall SOS Model for caregivers
The proportion of caregivers with a 95% confidence interval who completed screening questionnaires and received information resource sheets who report it as acceptable as measured by response to a text message: "Thinking about your recent outpatient clinic appointment with your child at The Royal Children's Hospital, did you find the SOS Model (screening, outcomes and feedback, support pathways for your own mental health and wellbeing) acceptable?" Response: Yes/No
Measured: Day 7
The proportion of eligible caregivers who provide informed consent and enrol in the trial
The proportion of eligible caregivers with a 95% confidence interval who provide informed consent and enrol in the trial, calculated as the number of consenting participants divided by the total number of caregivers invited to participate.
Measured: Through study completion, an average of 6 months
The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 3-month survey.
The proportion of caregivers, with a 95% confidence interval, who report following up on a recommended service on the information resource sheet on the 3-month survey.
Measured: 3 months
The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 6-month survey.
The proportion of caregivers, with a 95% confidence interval, who report following up on a recommended service on the information resource sheet on the 6-month survey.
Measured: 6 months
Secondary outcomes (36)
The proportion of caregivers reporting comfort (acceptability) when completing the mental health survey as measured on a Likert scale on a study-designed survey
The proportion of caregivers, with a 95% confidence interval, who report a level of comfort when completing the mental health survey in the outpatient clinic setting using a study-designed measure in the caregiver survey Response: 5-point Likert scale ranging from 1= Very uncomfortable to 5 = Very comfortable
Measured: 3 months
The proportion of caregivers who would recommend to others completing a mental health and wellbeing survey (acceptability) as measured on a Likert scale on a study-designed survey
The proportion of caregivers, with a 95% confidence interval, who would recommend completing a mental health and wellbeing survey to others as using a study-designed measure in the caregiver survey.
Response: 5-point Likert scale ranging from 1= very unlikely to 5= very likely
Measured: 3 months
The proportion of caregivers reporting comfort (acceptability) when discussing their survey results with a clinician as measured on a Likert scale on a study-designed survey
- The proportion of caregivers, with a 95% confidence interval, who report feeling comfortable discussing their mental health and wellbeing questionnaire results with one of the clinicians asked on a study-designed measure in the caregiver survey
- Response: 5-point Likert scale ranging from 1= Very uncomfortable to 5= Very comfortable.
Measured: 3 months
The proportion of clinicians who report feeling their interactions were well-received in a survey on their experience as measured on a Likert scale on a study-designed survey
The proportion of clinicians, with a 95% confidence interval, who report feeling their interactions were well-received in a survey on their experience (acceptability) Response: 5-point Likert scale ranging from 1= Not very well-received to 5= Very well-received
Measured: 4 weeks
The proportion of clinicians who report feeling that caregivers understood the feedback results in a survey on their experience (acceptability) as measured on a Likert scale on a study-designed survey
The proportion of clinicians, with a 95% confidence interval, who report feeling that caregivers understood the feedback results in study-designed measure in a survey on their experience Response: 5-point Likert scale ranging from 1= Did not understand at all to 5= Understood very well.
Measured: 4 weeks
The proportion of clinicians who report they found the process of discussing a caregiver's mental health easy (acceptability) in a study-designed measure in a survey on their experience
The proportion of clinicians, with a 95% confidence interval, who report they found the process of discussing a caregiver's mental health easy in a study-designed measure in a survey on their experience Response: 5-point Likert scale ranging from 1= Not easy at all to 5= Very easy
Measured: 4 weeks
The proportion of clinicians who report they found the whole SOS model (screening, outcomes and support pathways) an acceptable addition to the clinic on a survey on their experience (acceptability)
The proportion of clinicians, with a 95% confidence interval, who report they found the whole SOS model (screening and referrals pathway) an acceptable addition to the clinic on a survey on their experience Response: Y/N
Measured: 4 weeks
The proportion of clinicians who consent to take part in the workshop and trial (feasibility of clinician recruitment)
The proportion of clinicians, with a 95% confidence interval, who take part in the workshop and trial, calculated as the number of consenting clinicians divided by the total number of caregivers invited to take part in the workshop.
Measured: Through study completion, an average of 6 months
The proportion of clinicians who respond that the SOS Model is feasible as per the 4-item Feasibility of Intervention Measure.
The proportion of clinicians, with a 95% confidence interval, who respond on the following Feasibility of Intervention Measure items:
(i) The SOS Model seems implementable (ii) The SOS Model seems possible (iii) The SOS Model seems doable (iv) The SOS Model seems easy to use Response: 5-point Likert scale for each item ranging from 1 Completely disagree to 5 Completely agree
Measured: 4 weeks
Time required for the clinician to discuss feedback and provide information as measured on a Likert scale on a study-designed survey (feasibility)
Clinicians' responses on how long on average it took to discuss feedback and provide information on a study-designed measure of their experience Response: 5-point Likert scale ranging from 1 (0-5 mins), 3 (10-15 mins) to 5 (>20 mins)
Measured: 4 weeks
Clinician feedback on whether the mental health screening survey would add to their workload based on an open-ended question in a study designed survey (feasibility)
Study-designed, open ended question asking clinicians in what way they think this screening tool would add to their workload on a survey of their experience
Measured: 4 weeks
The proportion of consenting caregivers who complete all study procedures
The proportion, with a confidence interval of 95%, of consenting caregivers who complete all procedures at baseline
Measured: Baseline
The proportion of consenting caregivers who complete all study procedures
The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 3 months
Measured: 3 months
The proportion of consenting caregivers who complete all study procedures
The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 6 months
Measured: 6 months
The proportion of caregivers who report receiving feedback from the clinician after completing the mental health and wellbeing survey
The proportion of caregivers, with a 95% confidence interval, who report a clinician vs researcher provided feedback for their mental health survey. (Aiming to determine who provided the feedback).
Response: clinician vs researcher
Measured: 3 months
The proportion of caregivers who report being provided with an information resource sheet after completing their mental health and wellbeing survey (implementation fidelity)
The proportion of caregivers, with a 95% confidence interval, who report being provided with an information resource sheet after completing their mental health survey on a study-designed measure Response: Yes/No
Measured: 3 months
The proportion of caregivers who report benefits from the referral recommendations as measured on a Likert scale on a study-designed survey
The proportion of caregivers, with a 95% confidence interval, who report on a study-designed survey that the recommendations on the resource sheet were useful for them Response: 5-point Likert scale ranging from 1= Not useful at all to 5= Very useful
Measured: 3 months
Barriers for caregivers to take up a recommended service as measured on a multiple response question on a study-designed survey
The proportion of caregivers, with a 95% confidence interval, who select one or more barriers to accessing a recommendation or service as listed on a study-designed survey if they scored above the clinical cut points on the DASS-21 total score OR one or more of the subscale scores for anxiety, depression or stress
Response:
- I prefer to handle any problems on my own or with help from family/friends
- I am still waiting for an appointment
- The option was too expensive
- It is too hard to get to
- I do not have the time or stamina
- The hours available for some services didn't suit
- My health stopped me
- Cultural or language reasons
- I felt it would make no difference
- I felt it would be too stressful
- Other, please say
Measured: 3 months
Changes in the mean total score between baseline and 6 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21)
The comparison of mean DASS-21 total scores between baseline and 6-month follow-up among caregivers. Minimum score: 0, Maximum score: 63, Higher scores = worse outcomes.
Measured: Baseline, 6 months
Changes in the mean total scores of caregivers between baseline and 3 months as measured on the EuroQol five-dimensional five-level version (EQ-5D-5L)
The comparison of mean EQ-5D-5L scores between baseline and 3-months follow up among caregivers. The EQ-5D-5L is a standardized instrument used to measure health-related quality of life (HRQOL). The "5D" refers to the five dimensions of health that are assessed: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The "5L" indicates that each dimension has five levels of response options, ranging from no problems to extreme problems. Scores are between 0-1.Higher scores indicate better outcomes (better health-related quality of life).
Measured: Baseline, 3 months
Changes in the mean total scores of caregivers between baseline and 6 months as measured on the EuroQol five-dimensional five-level version (EQ-5D-5L)
The comparison of mean EQ-5D-5L scores between baseline and 6-month follow up among caregivers. Scores are between 0-1. Higher scores indicate better outcomes (better health-related quality of life).
Measured: baseline, 6 months
Changes in the mean total score of the visual analogue scale on the EuroQol five-dimensional five-level version (EQ-5D-5L) of caregivers between baseline and 6 months
The comparison in mean EQ-5D-5L visual analogue scale scores between baseline and 6-month follow up in caregivers. Scores are between 0-100. Higher scores indicate better outcomes (better self-rated health).
Measured: baseline, 6 months
The proportion of caregivers with mental health scores above the cut-off scores for the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at baseline
The proportion of caregivers, with a 95% confidence interval, with a total score above the cut-off point (≥40) on the DASS-21 The proportion of caregivers, with a 95% confidence interval, with a subscale score above the clinical cut points: ≥14 for depression; ≥10for anxiety, and ≥19 for stress. Scores possible for each subscale: Minimum - 0, maximum - 21. Higher levels = worse outcome.
Measured: Baseline
The proportion of caregivers with mental health scores above the cut off scores on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 3 months.
The proportion of caregivers, with a 95% confidence interval, with a total score above the cut-off point (≥40) on the DASS-21 The proportion of caregivers, with a 95% confidence interval, with a subscale score above the clinical cut points: ≥14 for depression; ≥10for anxiety, and ≥19 for stress. Scores possible for each subscale: Minimum - 0, maximum - 21. Higher scores = worse outcome.
Measured: 3 months
The proportion of caregivers with mental health scores above clinical cut off scores on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 6 months
The proportion of caregivers, with a 95% confidence interval, with a total score above the cut-off point (≥40) on the DASS-21 The proportion of caregivers, with a 95% confidence interval, with a subscale score above the clinical cut points: ≥14 for depression; ≥10for anxiety, and ≥19 for stress. Scores possible for each subscale: Minimum - 0, maximum - 21. Higher score = worse outcome.
Measured: 6 months
The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at baseline.
The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Measured: Baseline
The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 3 months
The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Measured: 3 months
The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 6 months
The mean total score for caregivers on the DASS-21. Total score: Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Measured: 6 months
The mean total score for caregivers at baseline as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the EQ-5D-5L in caregivers Scores are between 0-1. Higher scores indicate better outcomes (better health-related quality of life).
Measured: baseline
The mean total score for caregivers at 3 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the EQ-5D-5L in caregivers. Scores are between 0-1. Higher scores indicate better outcomes (better health-related quality of life)
Measured: 3 months
The mean total score for caregivers at 6 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the EQ-5D-5L in caregivers. Scores are between 0-1. Higher scores indicate better outcomes (better health-related quality of life).
Measured: 6 months
The mean total score for caregivers at baseline as measured on the visual analogue scale on the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the visual analogue scale on the EQ-5D-5L in caregivers Scores are between 0-100. Higher scores indicate better outcomes (better self-rated health)
Measured: baseline
The mean total score for caregivers at 3 months as measured on the visual analogue scale on the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the visual analogue scale on the EQ-5D-5L in caregivers Scores are between 0-100. Higher scores indicate better outcomes (better self-rated health).
Measured: 3 months
Changes in the mean total score between baseline and 3 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21).
The comparison of mean DASS-21 total scores between baseline and 3-month follow-up among caregivers. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Measured: baseline, 3 months
Changes in the mean total score of the visual analogue scale of the EuroQol five-dimensional five-level version (EQ-5D-5L) at baseline and 3 months.
The comparison in mean EQ-5D-5L visual analogue scale scores between baseline and 3-month follow up in caregivers. Scores are between 0-100. Higher scores indicate better outcomes (better self-rated health)
Measured: baseline, 3 months
The mean total score for caregivers at 6 months as measured on the visual analogue scale on the EuroQol five-dimensional five-level version (EQ-5D-5L).
The mean total score on the visual analogue scale on the EQ-5D-5L in caregivers Scores are between 0-100. Higher scores indicate better outcomes (better self-rated health).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start22 Oct 2025
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murdoch Childrens Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, University of Melbourne, Royal Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Nadia Coscini, BA, MBBS, MSc, Principal investigator, Murdoch Children's Research Institute & University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136584
- Sponsor's protocol ID
- HREC116190
- Acronym
- SOS
- Status last verified
- Oct 2026
- First submitted
- 7 Aug 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data (IPD) will be shared with other researchers. The specific information that will be made available includes the study protocol, statistical analysis plan, informed consent form templates, and the final report containing de-identified participant data summarised in tables and figures.
Publications
Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.
PubMed 28851459Coscini N, McMahon G, Schulz M, Hosking C, Mulraney M, Grobler A, Hiscock H, Giallo R. Screening parents of children with a chronic condition for mental health problems: a systematic review. Arch Dis Child. 2025 Aug 18;110(9):722-728. doi: 10.1136/archdischild-2024-328300.
PubMed 39978866