NCT03705221

Healthy Parent Carers Feasibility Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of Exeter · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Health Behavior

Interventions

Type	Name	Description
BEHAVIORAL	Healthy Parent Carers group programme	Peer-led group-based weekly programme.
BEHAVIORAL	Healthy Parent Carers online resources	Online resources related to health and wellbeing

Timeline

• Start date: 2018-10-29
• Primary completion: 2020-02-04
• Completion: 2020-02-04
• First posted: 2018-10-15
• Last updated: 2020-09-16

Locations

6 sites across 1 country: United Kingdom