Healthy Parent Carers Feasibility Study

Not Applicable

Completed

• Conditions: Health Behavior
• Interventions: Behavioral: Healthy Parent Carers group programme; Behavioral: Healthy Parent Carers online resources

• Registration Number: NCT03705221
• Lead Sponsor: University of Exeter

Brief 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.

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.

Study Timeline

• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-15
• Study Start: 2018-10-29
• Primary Completion: 2020-02-04
• Study Completion: 2020-02-04
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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.

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Exclusion Criteria

• a) Not able to communicate in English.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group programme	Healthy Parent Carers 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.
Online resources	Healthy Parent Carers 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.

Primary Outcome Measures

Name	Time	Method
Warwick-Edinburgh Mental Well-being Scale	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 Outcome Measures

Name	Time	Method
Programme Feedback Form	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.
EQ-5D-5L	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.
Warwick-Edinburgh Mental Well-being Scale	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.
Parents' Assessment of Protective Factors	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.
Patient Activation Measure (PAM)	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.
PHQ-9	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	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.
ICEpop CAPability measure for Adults (ICECAP-A)	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	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).

Trial Locations

Locations (6)

Woodlands School; 🇬🇧 Plymouth, Devon, United Kingdom

Torbay Parent Carer Forum; 🇬🇧 Torquay, Devon, United Kingdom

Learn Devon Bideford; 🇬🇧 Bideford, Devon, United Kingdom

Children's Hospice South West Little Harbour; 🇬🇧 Saint Austell, Cornwall, United Kingdom

Orchard Manor School; 🇬🇧 Dawlish, Devon, United Kingdom

The Beach Hotel; 🇬🇧 Minehead, Somerset, United Kingdom