Randomised Controlled Feasibility Study and Exploratory Trial of the Carers-ID Intervention: Supporting Family Carers' Mental Health Following the COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Retention of Subjects in Study Assessments
研究概览
简要总结
Brief Summary:
Background: Feasibility and acceptability of the Carers-ID intervention to improve mental health outcomes in family carers of people with intellectual disabilities.
Objective:
- To conduct a Phase II feasibility randomised controlled trial and process evaluation of the Carers-ID programme.
- To determine the acceptability of outcome measures of stress, anxiety, depression, resilience and well-being in assessing the impact of the programme on family carers.
- To determine the recruitment and retention rates of participants in the trial.
- To identify potential effect sizes and estimate appropriate sample size for use in an effectiveness trial.
- To determine if progression to a phase III effectiveness trial is warranted.
Methodology:
Family carers (n = 120) will be randomised to receive the programme (n=60) or assigned to a wait-list control (n=60) group. The intervention (Carers-ID) consists of ten modules which cover topics including: promoting resilience, reducing anxiety, managing stress, accessing local supports, managing family conflict and information for siblings who are carers. Participants (n=12) who have taken part in the intervention arm of the research will be invited to participate in the process evaluation.
Outcome:
- Retention of Subjects in Study Assessments (>80% of family carers)
- Recruitment of Subjects into Study (>90 carers)
- Acceptability and feasibility of the outcome measures (>80% of family carers)
- Depression, Anxiety and Stress Scale - 21; The Warwick-Edinburgh Mental Well-being Scale; The Resilience Scale; and The Social Connectedness Scale Revised.
Number of participants to be enrolled: 120 family carers
Main inclusion criteria: Participants will be UK adults >18 years of age and will be caring for a family member with an intellectual disability.
Statistical Analysis: Descriptive statistics will be used to summarise baseline data including demographic variables and questionnaire responses. Inferential statistics (t-tests or ANOVA) will be used as indicators of difference between the intervention and control arms and will be used to determine effect sizes for sample size calculation in a future phase III trial.
Study duration: 24 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Random allocation to the intervention and control conditions will be undertaken by an independent third party not involved with the research. Members of the research team will be blind to allocation to reduce selection bias.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Resident of the UK;
- •>18 years of age;
- •Caring for a family member with an intellectual disability.
排除标准
- 未提供
结局指标
主要结局
Retention of Subjects in Study Assessments
时间窗: 3 months
Retain 80% of intervention and control participants
Acceptability and feasibility of the outcome measures
时间窗: 6 months
Acceptability and feasibility of the outcome measures determined by process evaluation (\>80% of family carers).
Recruitment of Subjects Into Study
时间窗: 3 months
Sufficient recruitment is set as \>90 family carers.
次要结局
- The Resilience Scale (RS-25)(Baseline (T0), 2 weeks (T1), 3 months (T2))
- The Social Connectedness Scale Revised(Baseline (T0), 2 weeks (T1), 3 months (T2))
- Depression, Anxiety and Stress Scale - 21 (DASS-21)(Baseline (T0), 2 weeks (T1), 3 months (T2))
- The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)(Baseline (T0), 2 weeks (T1), 3 months (T2))
研究者
Dr Mark Linden
Reader
Queen's University, Belfast