- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cornwall
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Saint Austell, Cornwall, United Kingdom, PL26 6AZ
- Children's Hospice South West Little Harbour
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Devon
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Bideford, Devon, United Kingdom, EX39 2EY
- Learn Devon Bideford
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Dawlish, Devon, United Kingdom, EX7 9SF
- Orchard Manor School
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Plymouth, Devon, United Kingdom, PL6 5ES
- Woodlands School
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Torquay, Devon, United Kingdom, TQ2 5QB
- Torbay Parent Carer Forum
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Somerset
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Minehead, Somerset, United Kingdom, TA24 5AP
- The Beach Hotel
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Peer-led group-based weekly programme.
|
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.
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Online resources related to health and wellbeing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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 months post-intervention
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
6 months post-intervention
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
6 months post-intervention
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
6 months post-intervention
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
6 months post-intervention
|
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.
|
Baseline
|
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.
|
Immediately post-intervention (up to 12 weeks)
|
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.
|
6 months post-intervention
|
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).
|
Baseline
|
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).
|
Immediately post-intervention (up to 12 weeks)
|
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).
|
6 months post-intervention
|
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.
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Immediately post-intervention (up to 12 weeks)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chris Morris, DPhil, University of Exeter
Publications and helpful links
General Publications
- 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.
- Bjornstad G, Cuffe-Fuller B, Ukoumunne OC, Fredlund M, McDonald A, Wilkinson K, Lloyd J, Hawton A, Berry V, Tarrant M, Borek A, Fitzpatrick K, Gillett A, Rhodes S, Logan S, Morris C. Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children. Pilot Feasibility Stud. 2021 Jul 23;7:144. doi: 10.1186/s40814-021-00881-5. eCollection 2021.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NIHR RfPB PB-PG-0317-20044
- 246169 (Other Identifier: IRAS)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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