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SOS for Caregiver Wellbeing

Study acronym: SOS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Aug 2026 → Nov 2026
See other at-risk trials from Murdoch Childrens Research Institute

Record History

  1. Enrollment closed, study ongoing Primary and study completion pushed from Aug 2026 to Nov 2026 · Final enrollment: 123 participants (planned 100) · Secondary endpoints: details revised at 27 of 36 entries · 5 more Show 8 more changesShow less
    • Primary and study completion pushed from Aug 2026 to Nov 2026
    • Final enrollment: 123 participants (planned 100)
    • Secondary endpoints: details revised at 27 of 36 entries
    • Study description expanded, about 11 words
    • Site details revised
    • Collaborators: details revised at 1 of 3 entries
    • Publications: details revised at 2 of 2 entries
    • Eligibility criteria expanded, about 3 words
  2. Primary and study completion dates: Apr 28, 2026 to Aug 2026v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 15, 2025 to Oct 22, 2025 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Oct 15, 2025 to Oct 22, 2025
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07136584
Lead Sponsor Murdoch Childrens Research Institute
Collaborators: National Health and Medical Research Council, Australia, University of Melbourne, Royal Children's Hospital
Conditions Mental Health, Depression and Burden in Caregivers, Anxiety Depression, Stress, Caregiver Anxiety, Parent of Child With Chronic Life-threatening Illness
Enrollment 123 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov