Healthy Parent Carers Programme: Feasibility Study of a Peer-led Group-based Health Promotion Intervention for Parent Carers of Disabled Children Using a Parallel Group Randomised Controlled Trial Design
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 12
- 主要终点
- Warwick-Edinburgh Mental Well-being Scale
研究概览
简要总结
This study is a feasibility study of a peer-led group-based health promotion intervention for parent carers. It will used a parallel group randomised controlled trial design to compare a group based intervention called Healthy Parent Carers, with online resources about improving health and wellbeing.
详细描述
The objectives of the study are:
- to evaluate whether the programme can be delivered in the community, and
- to provide information necessary to design a definitive randomised controlled trial.
The investigators aim to recruit at least 96 parent carers of children with special educational needs and disabilities aged up to 25 years in six sites in Devon, Cornwall and Somerset. Participants will be individually randomised, stratified by group delivery site when recruitment in each site is completed, to either take part in a group programme, which includes online Healthy Parent Carer programme materials (intervention), or to receive access to the online materials for self-study only (control).
The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions. Groups will consist of at least 6 parent carers. The participant materials will be provided online.
Demographics will be collected at baseline. Participants will complete measures of mental health, wellbeing, health-related quality of life, health behaviours, patient activation, protective factors, and resource use. These data will be collected before randomisation (baseline), at post-intervention (i.e. after the intervention arm completes the group programme), and at 6 months post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •a) Primary carers of children who identify that their children have additional needs and/or disabilities. Participants who self-identify as primary carers are eligible. The child should be up to 25 years old (this age range is consistent with the current UK Department of Health and Department of Education Special Educational Needs & Disability (SEND) legislation and The Children's Act);
- •b) Willing and able to attend the programme group meeting session(s) on arranged dates/times;
- •c) Able to access online information.
排除标准
- •a) Not able to communicate in English.
结局指标
主要结局
Warwick-Edinburgh Mental Well-being Scale
时间窗: 6 months post-intervention
The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 14-item scale used to assess mental wellbeing in the general population and in evaluation of programmes aiming to improve mental wellbeing.
次要结局
- Programme Feedback Form(Immediately post-intervention (up to 12 weeks))
- EQ-5D-5L(6 months post-intervention)
- Warwick-Edinburgh Mental Well-being Scale(Immediately post-intervention (up to 12 weeks))
- Parents' Assessment of Protective Factors(6 months post-intervention)
- Patient Activation Measure (PAM)(6 months post-intervention)
- PHQ-9(6 months post-intervention)
- Health Promoting Activities Scale(6 months post-intervention)
- ICEpop CAPability measure for Adults (ICECAP-A)(6 months post-intervention)
- Service and Resource Use questionnaire(6 months post-intervention)