SOS for Caregiver Wellbeing: Testing the Feasibility of a Screening, Outcomes and Support (SOS) Model for Parents and Caregivers of Children With Chronic Conditions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Acceptability of the overall SOS Model for caregivers
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •need for an interpreter to complete informed consent
研究组 & 干预措施
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.
干预措施: Screening, Outcomes and Referral Pathways (Other)
结局指标
主要结局
Acceptability of the overall SOS Model for caregivers
时间窗: Day 7
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
The proportion of eligible caregivers who provide informed consent and enrol in the trial
时间窗: Through study completion, an average of 6 months
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.
The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 3-month survey.
时间窗: 3 months
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.
The proportion of caregivers who report following up on a recommended service on the information resource sheet on the 6-month survey.
时间窗: 6 months
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.
次要结局
- 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)
- 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(4 weeks)
- 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)(4 weeks)
- The proportion of clinicians who consent to take part in the workshop and trial (feasibility of clinician recruitment)(Through study completion, an average of 6 months)
- The proportion of clinicians who respond that the SOS Model is feasible as per the 4-item Feasibility of Intervention Measure.(4 weeks)
- Time required for the clinician to discuss feedback and provide information as measured on a Likert scale on a study-designed survey (feasibility)(4 weeks)
- 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)(4 weeks)
- The proportion of consenting caregivers who complete all study procedures(6 months)
- The proportion of caregivers who report receiving feedback from the clinician after completing the mental health and wellbeing survey(3 months)
- The proportion of caregivers who report being provided with an information resource sheet after completing their mental health and wellbeing survey (implementation fidelity)(3 months)
- The proportion of caregivers who report benefits from the referral recommendations as measured on a Likert scale on a study-designed survey(3 months)
- Barriers for caregivers to take up a recommended service as measured on a multiple response question on a study-designed survey(3 months)
- Changes in the mean total score between baseline and 6 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21)(Baseline, 6 months)
- 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)(Baseline, 3 months)
- The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 3 months(3 months)
- 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)(baseline, 6 months)
- 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(baseline, 6 months)
- 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(Baseline)
- 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.(3 months)
- 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(6 months)
- The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at baseline.(Baseline)
- The mean total score for caregivers on the Depression, Anxiety and Stress Scale - 21-item (DASS-21) at 6 months(6 months)
- The mean total score for caregivers at baseline as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).(baseline)
- The mean total score for caregivers at 3 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).(3 months)
- The mean total score for caregivers at 6 months as measured by the EuroQol five-dimensional five-level version (EQ-5D-5L).(6 months)
- 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).(baseline)
- 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).(3 months)
- Changes in the mean total score between baseline and 3 months as measured on the Depression, Anxiety and Stress Scale - 21-item (DASS-21).(baseline, 3 months)
- 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.(baseline, 3 months)
- 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).(6 months)