SOS for Caregiver Wellbeing

NCT07136584 | Recruiting

• 1 other identifier: HREC116190
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

parent; caregiver; chronic illness; screening; mental health; anxiety; depression; stress; referral pathways

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (36)

• The proportion of caregivers reporting comfort (acceptability) when completing the mental health survey as measured on a Likert scale on a study-designed survey

  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

  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

  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

  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

  4 weeks

Study Arms (1)

Screening outcome - information resource sheet

OTHER

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: Screening, Outcomes and Referral Pathways

Interventions

Screening, Outcomes and Referral Pathways 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.

Screening outcome - information resource sheet

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• need for an interpreter to complete informed consent

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• National Health and Medical Research Council, Australia: collaborator
• University of Melbourne: collaborator
• Royal Children's Hospital: collaborator

Study Sites (1)

Outpatient clinics - Royal Children's Hospital

Parkville, Victoria, 3052, Australia

RECRUITING

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Depression; Chronic Disease; Anxiety Disorders

Interventions

Mass Screening; Treatment Outcome

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Behavioral Symptoms; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Prognosis; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Health Services Administration

Study Officials

• Nadia Coscini, BA, MBBS, MSc

  Murdoch Children's Research Institute & University of Melbourne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Coscini, BA, MBBS, MSc

CONTACT

+61 3 8341 6762; nadia.coscini@mcri.edu.au

Harriet Hiscock, MBBS, MD

CONTACT

+61 3 9345 6910; harriet.hiscock@rch.org.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 22, 2025
• Study Start: October 22, 2025
• Primary Completion: April 28, 2026
• Study Completion: April 28, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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)
• Access Criteria: 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)

Locations

AU (1)