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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07136584
Registration number
NCT07136584
Ethics application status
Date submitted
7/08/2025
Date registered
22/08/2025
Date last updated
22/08/2025
Titles & IDs
Public title
SOS for Caregiver Wellbeing
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Scientific 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
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Secondary ID [1]
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HREC116190
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Universal Trial Number (UTN)
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Trial acronym
SOS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mental Health
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Depression and Burden in Caregivers
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Anxiety Depression
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Stress
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Caregiver Anxiety
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Parent of Child With Chronic Life-threatening Illness
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Condition category
Condition code
Mental Health
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0
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Depression
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Mental Health
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Screening, Outcomes and Referral Pathways
Other: Screening outcome - information resource sheet - 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.
Other interventions: 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 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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Acceptability of the overall SOS Model for caregivers
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Assessment method [1]
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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
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Timepoint [1]
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Day 7
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Primary outcome [2]
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The proportion of eligible caregivers who provide informed consent and enrol in the trial
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Assessment method [2]
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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.
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Timepoint [2]
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Through study completion, an average of 6 months
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Primary outcome [3]
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The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 3-month survey.
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Assessment method [3]
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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.
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Timepoint [3]
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3 months
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Primary outcome [4]
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The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 6-month survey.
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Assessment method [4]
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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.
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Timepoint [4]
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6 months
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Secondary outcome [1]
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The proportion of caregivers reporting comfort (acceptability) when completing the mental health survey as measured on a Likert scale on a study-designed survey
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Assessment method [1]
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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
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Timepoint [1]
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3 months
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Secondary outcome [2]
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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
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Assessment method [2]
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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
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Timepoint [2]
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3 months
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Secondary outcome [3]
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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
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Assessment method [3]
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* 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.
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Timepoint [3]
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3 months
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Secondary outcome [4]
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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
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Assessment method [4]
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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
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Timepoint [4]
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4 weeks
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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4 weeks
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Secondary outcome [6]
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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
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Assessment method [6]
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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
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Timepoint [6]
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4 weeks
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Secondary outcome [7]
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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)
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Assessment method [7]
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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
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Timepoint [7]
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4 weeks
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Secondary outcome [8]
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The proportion of clinicians who consent to take part in the workshop and trial (feasibility of clinician recruitment)
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Assessment method [8]
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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.
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Timepoint [8]
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Through study completion, an average of 6 months
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Secondary outcome [9]
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The proportion of clinicians who respond that the SOS Model is feasible as per the 4-item Feasibility of Intervention Measure.
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Assessment method [9]
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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
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Timepoint [9]
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4 weeks
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Secondary outcome [10]
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Time required for the clinician to discuss feedback and provide information as measured on a Likert scale on a study-designed survey (feasibility)
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Assessment method [10]
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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)
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Timepoint [10]
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4 weeks
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Secondary outcome [11]
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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)
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Assessment method [11]
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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
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Timepoint [11]
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4 weeks
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Secondary outcome [12]
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The proportion of consenting caregivers who complete all study procedures
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Assessment method [12]
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The proportion, with a confidence interval of 95%, of consenting caregivers who complete all procedures at baseline
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Timepoint [12]
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Baseline
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Secondary outcome [13]
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The proportion of consenting caregivers who complete all study procedures
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Assessment method [13]
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The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 3 months
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Timepoint [13]
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3 months
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Secondary outcome [14]
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The proportion of consenting caregivers who complete all study procedures
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Assessment method [14]
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The proportion of consenting caregivers, with a 95% confidence interval, who complete all procedures at 6 months
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Timepoint [14]
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6 months
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Secondary outcome [15]
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The proportion of caregivers who report receiving feedback from the clinician after completing the mental health and wellbeing survey
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Assessment method [15]
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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
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Timepoint [15]
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3 months
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Secondary outcome [16]
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The proportion of caregivers who report being provided with an information resource sheet after completing their mental health and wellbeing survey (implementation fidelity)
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Assessment method [16]
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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
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Timepoint [16]
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3 months
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Secondary outcome [17]
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The proportion of caregivers who report benefits from the referral recommendations as measured on a Likert scale on a study-designed survey
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Assessment method [17]
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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
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Timepoint [17]
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3 months
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Secondary outcome [18]
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Barriers for caregivers to take up a recommended service as measured on a multiple response question on a study-designed survey
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Assessment method [18]
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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
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Timepoint [18]
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3 months
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Secondary outcome [19]
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Changes in the mean total score between baseline and 6 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21)
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, 6 months
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Secondary outcome [20]
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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)
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Assessment method [20]
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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).
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Timepoint [20]
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Baseline, 3 months
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Secondary outcome [21]
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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)
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Assessment method [21]
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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).
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Timepoint [21]
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baseline, 6 months
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Secondary outcome [22]
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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
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Assessment method [22]
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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).
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Timepoint [22]
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baseline, 6 months
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Secondary outcome [23]
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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
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline
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Secondary outcome [24]
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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.
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Assessment method [24]
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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.
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Timepoint [24]
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3 months
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Secondary outcome [25]
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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
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Assessment method [25]
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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.
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Timepoint [25]
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6 months
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Secondary outcome [26]
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The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at baseline.
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Assessment method [26]
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The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
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Timepoint [26]
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Baseline
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Secondary outcome [27]
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The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 3 months
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Assessment method [27]
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The mean total score for caregivers on the DASS-21. Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
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Timepoint [27]
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3 months
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Secondary outcome [28]
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The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 6 months
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Assessment method [28]
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The mean total score for caregivers on the DASS-21. Total score: Scores: Minimum: 0, Maximum: 63. Higher scores = worse outcomes.
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Timepoint [28]
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6 months
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Secondary outcome [29]
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The mean total score for caregivers at baseline as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
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Assessment method [29]
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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).
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Timepoint [29]
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0
baseline
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Secondary outcome [30]
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The mean total score for caregivers at 3 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
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Assessment method [30]
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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)
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Timepoint [30]
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3 months
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Secondary outcome [31]
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0
The mean total score for caregivers at 6 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).
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Assessment method [31]
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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).
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Timepoint [31]
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6 months
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Secondary outcome [32]
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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).
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Assessment method [32]
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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)
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Timepoint [32]
0
0
baseline
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Secondary outcome [33]
0
0
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).
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Assessment method [33]
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0
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).
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Timepoint [33]
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3 months
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Secondary outcome [34]
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Changes in the mean total score between baseline and 3 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21).
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Assessment method [34]
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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.
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Timepoint [34]
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0
baseline, 3 months
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Secondary outcome [35]
0
0
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.
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Assessment method [35]
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0
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)
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Timepoint [35]
0
0
baseline, 3 months
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Secondary outcome [36]
0
0
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).
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Assessment method [36]
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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).
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Timepoint [36]
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6 months
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* need for an interpreter to complete informed consent
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
15/10/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
28/04/2026
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Outpatient clinics - Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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3052 - Parkville
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Funding & Sponsors
Primary sponsor type
Other
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Name
Murdoch Childrens Research Institute
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
0
0
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Country [1]
0
0
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
0
0
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Country [2]
0
0
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Other collaborator category [3]
0
0
Other
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Name [3]
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0
Royal Children's Hospital
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Address [3]
0
0
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Country [3]
0
0
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Ethics approval
Ethics application status
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Summary
Brief 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 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.
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Trial website
https://clinicaltrials.gov/study/NCT07136584
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Nadia Coscini, BA, MBBS, MSc
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Address
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Murdoch Children's Research Institute & University of Melbourne
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Country
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0
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Phone
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0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
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0
Nadia Coscini, BA, MBBS, MSc
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Address
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0
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Country
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0
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Phone
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0
+61 3 8341 6762
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Fax
0
0
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Email
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0
[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
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.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
Query!
When will data be available (start and end dates)?
Beginning 12 months following analysis and article publication (aim August 2028), the following will be made available long-term for use by future researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept Murdoch Children's Research Institute's (MCRI) conditions for access:
* Study protocol, Participant Information and Consent Forms (PICF), surveys
* Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices)
Query!
Available to whom?
Researchers from a recognised research institution whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accept MCRI's conditions for access:
* Study protocol, PICF, surveys
* Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures, and appendices)
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://metis.melbournechildrens.com/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07136584
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