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Completed

NCT Number: NCT03705221

Healthy Parent Carers Feasibility Study

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.

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Key information

Conditions

Health Behavior Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospice South West Little Harbour, St Austell, Cornwall, United Kingdom

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About this study

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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healthy Parent Carers group programme

Behavioral

Peer-led group-based weekly programme.

Healthy Parent Carers online resources

Behavioral

Online resources related to health and wellbeing

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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).

  22. 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).

  23. 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).

  24. 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.

Sponsors and collaborators

Lead sponsor

University of Exeter

Other

Collaborators

  • University of Oxford

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 15, 2018
Registry last updated
Sep 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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