Healthy Parent Carers Feasibility Study

Health Behavior Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705221
• Other study ID #: NIHR RfPB PB-PG-0317-20044
• Secondary ID: 246169
• Status: Completed
• Phase: N/A
• Start date: October 29, 2018
• Est. completion date: February 4, 2020

Study information

• Verified date: September 2020
• Source: University of Exeter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: February 4, 2020
• Est. primary completion date: February 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Health Behavior

Intervention

Behavioral:
• Healthy Parent Carers group programme
Peer-led group-based weekly programme.
• Healthy Parent Carers online resources
Online resources related to health and wellbeing

Locations

Country	Name	City	State
United Kingdom	Learn Devon Bideford	Bideford	Devon
United Kingdom	Orchard Manor School	Dawlish	Devon
United Kingdom	The Beach Hotel	Minehead	Somerset
United Kingdom	Woodlands School	Plymouth	Devon
United Kingdom	Children's Hospice South West Little Harbour	Saint Austell	Cornwall
United Kingdom	Torbay Parent Carer Forum	Torquay	Devon

Sponsors (2)

Lead Sponsor	Collaborator
University of Exeter	University of Oxford

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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.	Baseline
Secondary	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.	Immediately post-intervention (up to 12 weeks)
Secondary	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.	6 months post-intervention
Secondary	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).	Baseline
Secondary	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).	Immediately post-intervention (up to 12 weeks)
Secondary	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).	6 months post-intervention
Secondary	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.	Immediately post-intervention (up to 12 weeks)

External Links

•   Healthy Parent Carers study website