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Life sciences · Interventional Study
ClinicalTrials.gov · October 9, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07136584). This is a study registration, not published results. Lead sponsor: Murdoch Childrens Research Institute. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 123 participants (ACTUAL). Conditions: Mental Health, Depression and Burden in Caregivers, Anxiety Depression, Stress, Caregiver Anxiety, Parent of Child With Chronic Life-threatening Illness. Interventions: OTHER: Screening, Outcomes and Referral Pathways. Primary outcome measures: Acceptability of the overall SOS Model for caregivers , Day 7; The proportion of eligible caregivers who provide informed consent and enrol in the trial , 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. , 3 months; The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 6-month survey. , 6 months. 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. 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.