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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Health Behavior
- Sponsor
- University of Exeter
- Enrollment
- 93
- Locations
- 6
- Primary Endpoint
- Warwick-Edinburgh Mental Well-being Scale
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
The objectives of the study are: 1. to evaluate whether the programme can be delivered in the community, and 2. 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. Recruitment will be monitored in order to plan for a definitive trial. Facilitators' adherence to the Facilitator Manual and participant engagement will be monitored using a facilitator checklist at the end of the sessions and we will audio-record the training sessions and group sessions. Participants' will provide feedback on the programme to assess the acceptability of the outcome measures. The investigators will conduct interviews with a sample of participants in both study arms and a focus group with facilitators to provide insights into intervention content, delivery and experience.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •a) Not able to communicate in English.
Outcomes
Primary Outcomes
Warwick-Edinburgh Mental Well-being Scale
Time Frame: 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.
Secondary Outcomes
- 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)