SOS for Caregiver Wellbeing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2026-04-28

Brief Summary

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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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Detailed Description

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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

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Mental Health Depression and Burden in Caregivers Anxiety Depression Stress Caregiver Anxiety Parent of Child With Chronic Life-threatening Illness

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Screening, Outcomes and Referral Pathways

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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