Healthy Parent Carers Feasibility Study

Overview

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.

Full Title of 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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 4, 2020

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.

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Group programme
    • Healthy Parent Carers group programme: A group-based peer led manualised programme called Healthy Parent Carers. The programme content is organised into 12 modules, which can be delivered over six longer (4-hour) sessions or 12 shorter (2-hour) sessions.
  • Active Comparator: Online resources
    • Healthy Parent Carers online resources: Online resources from the Healthy Parent Carers programme, including materials for 12 modules and related videos and audio files to illustrate the content.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Warwick-Edinburgh Mental Well-being Scale
    • Time Frame: Baseline
    • 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.
  • Warwick-Edinburgh Mental Well-being Scale
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • EQ-5D-5L
    • Time Frame: Baseline
    • 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.
  • EQ-5D-5L
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • EQ-5D-5L
    • Time Frame: 6 months post-intervention
    • 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.
  • PHQ-9
    • Time Frame: Baseline
    • 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.
  • PHQ-9
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • PHQ-9
    • Time Frame: 6 months post-intervention
    • 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.
  • Health Promoting Activities Scale
    • Time Frame: Baseline
    • 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.
  • Health Promoting Activities Scale
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • Health Promoting Activities Scale
    • Time Frame: 6 months post-intervention
    • 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.
  • Patient Activation Measure (PAM)
    • Time Frame: Baseline
    • 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.
  • Patient Activation Measure (PAM)
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • Patient Activation Measure (PAM)
    • Time Frame: 6 months post-intervention
    • 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.
  • Parents’ Assessment of Protective Factors
    • Time Frame: Baseline
    • 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.
  • Parents’ Assessment of Protective Factors
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • Parents’ Assessment of Protective Factors
    • Time Frame: 6 months post-intervention
    • 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.
  • ICEpop CAPability measure for Adults (ICECAP-A)
    • Time Frame: Baseline
    • 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.
  • ICEpop CAPability measure for Adults (ICECAP-A)
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.
  • ICEpop CAPability measure for Adults (ICECAP-A)
    • Time Frame: 6 months post-intervention
    • 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.
  • Service and Resource Use questionnaire
    • Time Frame: Baseline
    • 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).
  • Service and Resource Use questionnaire
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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).
  • Service and Resource Use questionnaire
    • Time Frame: 6 months post-intervention
    • 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).
  • Programme Feedback Form
    • Time Frame: Immediately post-intervention (up to 12 weeks)
    • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Exeter
  • Collaborator
    • University of Oxford
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chris Morris, DPhil, Principal Investigator, University of Exeter

References

Borek AJ, McDonald B, Fredlund M, Bjornstad G, Logan S, Morris C. Healthy Parent Carers programme: development and feasibility of a novel group-based health-promotion intervention. BMC Public Health. 2018 Feb 20;18(1):270. doi: 10.1186/s12889-018-5168-4.

Bjornstad G, Wilkinson K, Cuffe-Fuller B, Fitzpatrick K, Borek A, Ukoumunne OC, Hawton A, Tarrant M, Berry V, Lloyd J, McDonald A, Fredlund M, Rhodes S, Logan S, Morris C. Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design. Pilot Feasibility Stud. 2019 Nov 23;5:137. doi: 10.1186/s40814-019-0517-3. eCollection 2019.

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