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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
93
Peer-led group-based weekly programme.
Online resources related to health and wellbeing
Children's Hospice South West Little Harbour
St Austell, Cornwall, United Kingdom
Learn Devon Bideford
Bideford, Devon, United Kingdom
Orchard Manor School
Dawlish, Devon, United Kingdom
Woodlands School
Plymouth, Devon, United Kingdom
Warwick-Edinburgh Mental Well-being Scale
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.
Time frame: 6 months post-intervention
Warwick-Edinburgh Mental Well-being Scale
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.
Time frame: Baseline
Warwick-Edinburgh Mental Well-being Scale
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.
Time frame: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Time frame: Baseline
EQ-5D-5L
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Time frame: Immediately post-intervention (up to 12 weeks)
EQ-5D-5L
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Torbay Parent Carer Forum
Torquay, Devon, United Kingdom
The Beach Hotel
Minehead, Somerset, United Kingdom
The EuroQol-5 Dimensions (EQ-5D-5L) is a measure of health-related quality of life. It consists of five items measuring five dimensions of health-related quality of life (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a vertical visual analogue scale measuring self-rated health.
Time frame: 6 months post-intervention
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Time frame: Baseline
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Time frame: Immediately post-intervention (up to 12 weeks)
PHQ-9
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure that rates the frequency of symptoms and is designed for screening, diagnosing, monitoring, and measuring the severity of depression.
Time frame: 6 months post-intervention
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Time frame: Baseline
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Time frame: Immediately post-intervention (up to 12 weeks)
Health Promoting Activities Scale
The HPAS is an 8-item measure of a person's estimation of the frequency with which they participate in a range of activities that promote or maintain health and well-being.
Time frame: 6 months post-intervention
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Time frame: Baseline
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Time frame: Immediately post-intervention (up to 12 weeks)
Patient Activation Measure (PAM)
The PAM is a 13-item measure that measures the spectrum of skills, knowledge, and confidence in patients and captures the extent to which people feel engaged and confident in managing their own health and care.
Time frame: 6 months post-intervention
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Time frame: Baseline
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Time frame: Immediately post-intervention (up to 12 weeks)
Parents' Assessment of Protective Factors
The PAPF is a 36-item measure that assesses protective factors identified in the development of the Strengthening Families evidence-based parenting programme. These protective factors are: parental resilience, social connections, concrete support in times of need, and support of children's social and emotional competence.
Time frame: 6 months post-intervention
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Time frame: Baseline
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Time frame: Immediately post-intervention (up to 12 weeks)
ICEpop CAPability measure for Adults (ICECAP-A)
The ICECAP-A is a 5-item measure of capability, which includes the following aspects of wellbeing found to be important to adults in the UK: attachment, stability, achievement, enjoyment, and autonomy. A set of UK utility values is available for the ICECAP-A, enabling it to be used in economic evaluations.
Time frame: 6 months post-intervention
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Time frame: Baseline
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Time frame: Immediately post-intervention (up to 12 weeks)
Service and Resource Use questionnaire
We will develop a resource use questionnaire in collaboration with parent carers. This will include health, social care, participant and broader societal resource use, and draw on measures in the Database of Instruments for Resource Use Management (DIRUM).
Time frame: 6 months post-intervention
Programme Feedback Form
We will collect feedback from treatment and control arm participants about the Healthy Parent Carer materials and delivery via a feedback form. All participants will be asked to complete the feedback form at 15 weeks post-randomisation.
Time frame: Immediately post-intervention (up to 12 weeks)