SOS for Caregiver Wellbeing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening, Outcomes and Referral Pathways.
- Who it may be relevant to
- Registry conditions: Mental Health, Depression and Burden in Caregivers, Anxiety Depression, Stress. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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. 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.
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.
Interventions
- Other Screening, Outcomes and Referral Pathways
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
Primary outcome measures
- Acceptability of the overall SOS Model for caregivers [Time frame: Day 7]
- The proportion of eligible caregivers who provide informed consent and enrol in the trial [Time frame: 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. [Time frame: 3 months]
- The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 6-month survey. [Time frame: 6 months]
Secondary outcome measures (12)
- The proportion of caregivers reporting comfort (acceptability) when completing the mental health survey as measured on a Likert scale on a study-designed survey [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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) [Time frame: 4 weeks]
- The proportion of clinicians who consent to take part in the workshop and trial (feasibility of clinician recruitment) [Time frame: 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. [Time frame: 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) [Time frame: 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) [Time frame: 4 weeks]
- The proportion of consenting caregivers who complete all study procedures [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- need for an interpreter to complete informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Australia · 1 center
- Outpatient clinics - Royal Children's Hospital — Parkville
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. PMID 28851459
- Coscini 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. PMID 39978866
Identifiers
NCT: NCT07136584 · HREC116190