SOS for Caregiver Wellbeing
NAACTIVE_NOT_RECRUITING
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. 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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
SCREENING
Phase
- NA
Study ID
NCT07136584
Intervention or treatment
OTHER: Screening, Outcomes and Referral Pathways
Conditions
- Mental Health
- Depression and Burden in Caregivers
- Anxiety Depression
- Stress
- Caregiver Anxiety
- Parent of Child With Chronic Life-threatening Illness
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Outpatient clinics - Royal Children's Hospital
Select from list below to view details:
Outpatient clinics - Royal Children's Hospital
Parkville, Victoria, Australia
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Who is running the clinical trial?
MCRI
Murdoch Childrens Research Institute
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OTHER: Screening outcome - information resource sheet
| Other: Screening, Outcomes and Referral Pathways |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | 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. | 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. | 6 months |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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. | 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 | 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. | 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 | 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 | 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. | 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 | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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). | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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) | 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). | 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) | 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). | 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. | 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) | 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). | 6 months |
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References
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