Outpatient clinics - Royal Children's Hospital
Parkville, Victoria, 3052, Australia
Location status: Recruiting
NCT Number: NCT07136584
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.
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Interventional
Not applicable
Parkville, Victoria, 3052, Australia
Location status: Recruiting
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:
The support framework will include:
By evaluating this approach, the trial seeks to determine the:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 7
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
Time frame: Through study completion, an average of 6 months
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.
Time frame: 3 months
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.
Time frame: 6 months
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.
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
Time frame: 4 weeks
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
Time frame: 4 weeks
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.
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: Through study completion, an average of 6 months
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.
Time frame: 4 weeks
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
Time frame: 4 weeks
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)
Time frame: 4 weeks
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
Time frame: Baseline
The proportion, with a confidence interval of 95%, of consenting caregivers who complete all procedures at baseline
Time frame: 3 months
The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 3 months
Time frame: 6 months
The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 6 months
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 3 months
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:
Time frame: Baseline, 6 months
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.
Time frame: Baseline, 3 months
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).
Time frame: baseline, 6 months
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).
Time frame: baseline, 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Time frame: 3 months
The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Time frame: 6 months
The mean total score for caregivers on the DASS-21. Total score: Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
Time frame: baseline
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).
Time frame: 3 months
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)
Time frame: 6 months
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).
Time frame: baseline
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)
Time frame: 3 months
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).
Time frame: baseline, 3 months
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.
Time frame: baseline, 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)
Time frame: 6 months
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).
Contact information is provided by the study sponsor or research team.
Harriet Hiscock, MBBS, MD
CONTACT
Nadia Coscini, BA, MBBS, MSc
CONTACT
Murdoch Childrens Research Institute
Other
SOS for Caregiver Wellbeing: Testing the Feasibility of a Screening, Outcomes and Support (SOS) Model for Parents and Caregivers of Children With Chronic Conditions
Acronym: SOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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