Condition category
Not Applicable
Date applied
22/10/2018
Date assigned
25/10/2018
Last edited
05/12/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Protocol

Plain English Summary

Current plain English summary as of 22/05/2019:
Background and study aims
Parent carers of disabled children tend to have poorer mental and physical health than other parents. Researchers and parent carers have co-developed a programme to improve the health and wellbeing of parent carers of disabled children. The programme is led by parent carers and involves working with others in a group to encourage behaviours associated with better health and wellbeing. The behaviours are called CLANGERS: Connect, Learn, be Active, Notice, Give, Eat well, Relax and Sleep. Parent carers are given the Healthy Parent Carer Guide with information related to each session. The programme has been delivered once over six weekly sessions. Two parent carer facilitators led a group with seven participants. They felt the programme was valuable in building resilience and identifying specific strategies to deal with the challenges that parent carers commonly face. The aim of this study is to see whether the programme can be delivered in the community through organisations that have links with parent carers, and to test whether it improves health and wellbeing and is good value for money.

Who can participate?
Parent carers of children with special educational needs and disabilities aged up to 25 years

What does the study involve?
Parent carers are randomly allocated to either receive the group intervention or to receive the Healthy Parent Carer Guide information as online materials only. The group intervention is 12 modules which can be delivered over six 4-hour or 12 2-hour sessions. The online materials reflect the content of the group sessions. All parent carers complete questionnaires before and after the programme and 6 months later. The aim is to find out whether parent carers are willing to take part in a study like this, whether enough people sign up and stay to the end of the study, and whether the ways of measuring health and wellbeing are appropriate. If this study shows the group programme can be delivered and evaluated in this way, a larger study will be planned to test whether the programme improves parent carers’ health and wellbeing.

What are the possible benefits and risks of participating?
Participants receive access to the Healthy Parent Carers programme, either through access to online resources or by taking part in a group programme. All participants receive shopping vouchers as a thank you for their time completing the questionnaires. Participants are asked to complete questionnaires and some are asked to take part in interviews. If any of the questions make them feel uncomfortable, participants may decline to answer any particular questions. Taking part in the programme involves thinking about experiences and challenges as a parent carer. If during the course of this project the investigators become concerned about a participant’s wellbeing, this will be discussed with the participant. If the investigators have any safeguarding concerns they will be duty bound to contact a medical professional or the study safeguarding officer.

Where is the study run from?
University of Exeter Medical School (UK)

When is the study starting and how long is it expected to run for?
July 2018 to June 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)
National Lottery Community Fund

Who is the main contact?
1. Dr Gretchen Bjornstad
g.j.bjornstad@exeter.ac.uk
2. Dr Christopher Morris
christopher.morris@exeter.ac.uk


Previous plain English summary:
Background and study aims
Parent carers of disabled children tend to have poorer mental and physical health than other parents. Researchers and parent carers have co-developed a programme to improve the health and wellbeing of parent carers of disabled children. The programme is led by parent carers and involves working with others in a group to encourage behaviours associated with better health and wellbeing. The behaviours are called CLANGERS: Connect, Learn, be Active, Notice, Give, Eat well, Relax and Sleep. Parent carers are given the Healthy Parent Carer Guide with information related to each session. The programme has been delivered once over six weekly sessions. Two parent carer facilitators led a group with seven participants. They felt the programme was valuable in building resilience and identifying specific strategies to deal with the challenges that parent carers commonly face. The aim of this study is to see whether the programme can be delivered in the community through organisations that have links with parent carers, and to test whether it improves health and wellbeing and is good value for money.

Who can participate?
Parent carers of children with special educational needs and disabilities aged up to 25 years

What does the study involve?
Parent carers are randomly allocated to either receive the group intervention or to receive the Healthy Parent Carer Guide information as online materials only. The group intervention is 12 modules which can be delivered over six 4-hour or 12 2-hour sessions. The online materials reflect the content of the group sessions. All parent carers complete questionnaires before and after the programme and 6 months later. The aim is to find out whether parent carers are willing to take part in a study like this, whether enough people sign up and stay to the end of the study, and whether the ways of measuring health and wellbeing are appropriate. If this study shows the group programme can be delivered and evaluated in this way, a larger study will be planned to test whether the programme improves parent carers’ health and wellbeing.

What are the possible benefits and risks of participating?
Participants receive access to the Healthy Parent Carers programme, either through access to online resources or by taking part in a group programme. All participants receive shopping vouchers as a thank you for their time completing the questionnaires. Participants are asked to complete questionnaires and some are asked to take part in interviews. If any of the questions make them feel uncomfortable, participants may decline to answer any particular questions. Taking part in the programme involves thinking about experiences and challenges as a parent carer. If during the course of this project the investigators become concerned about a participant’s wellbeing, this will be discussed with the participant. If the investigators have any safeguarding concerns they will be duty bound to contact a medical professional or the study safeguarding officer.

Where is the study run from?
University of Exeter Medical School (UK)

When is the study starting and how long is it expected to run for?
July 2018 to June 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Gretchen Bjornstad
g.j.bjornstad@exeter.ac.uk
2. Dr Christopher Morris
christopher.morris@exeter.ac.uk

Trial website

http://sites.exeter.ac.uk/healthyparentcarers/

Contact information

Type

Public

Primary contact

Dr Gretchen Bjornstad

ORCID ID

http://orcid.org/0000-0003-4456-787X

Contact details

University of Exeter Medical School
South Cloisters
St Luke's Campus
Exeter
EX1 2LU
United Kingdom
+44 (0)1392727416
g.j.bjornstad@exeter.ac.uk

Type

Scientific

Additional contact

Dr Christopher Morris

ORCID ID

http://orcid.org/0000-0002-9916-507X

Contact details

University of Exeter Medical School
South Cloisters
St Luke's Campus
Exeter
EX2 2LU
United Kingdom
+44 (0)1392 262980
christopher.morris@exeter.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

NCT03705221

Protocol/serial number

40120; PB-PG-0317-20044

Study information

Scientific 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

Acronym

Study hypothesis

The aim of this feasibility study is to test whether the Healthy Parent Carers group-based programme can be delivered in community settings by trained peer-facilitators and online materials; and whether a randomised controlled trial to evaluate the effectiveness and cost-effectiveness of the intervention is both feasible and acceptable to participants.

Ethics approval

University of Exeter Medical School Research Ethics Committee, 20/08/2018, ref: 18/06/174

Study design

Randomised; Interventional; Design type: Prevention, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Other

Patient information sheet

http://sites.exeter.ac.uk/healthyparentcarers/files/2018/03/Participant-Information-Sheet-Version-2.pdf

Condition

Public health; parent carers of children with special educational needs or disability

Intervention

Current interventions as of 22/05/2019:
Method of randomisation: 8-24 participants will be randomised at each of 6 sites when recruitment is completed at each site. A computer-generated randomisation sequence will be used to assign the participants in each site to the intervention and control arms. A block randomisation scheme will be implemented to ensure equal allocations in the number of participants allocated to each trial arm, stratified by group delivery site. The allocation sequence will be concealed from investigators using an online central randomisation service set up and maintained by the Exeter Clinical Trials Unit.

The Healthy Parent Carers programme is a health promotion intervention to improve health and wellbeing for parent carers of disabled children. In this feasibility study, parent carers will be randomised to either a peer-led group-based programme with access to online materials (intervention) or to receiving online materials only (control). The group-based programme content is 12 modules, which can be delivered over six 4-hour or 12 2-hour sessions.

The programme aims to improve health and wellbeing by:
1. Encouraging parent carers to take time to reflect on their health and wellbeing
2. Inspiring motivation and self-efficacy
3. Introducing a set of simple, health-promoting actions with practical examples
4. Prompting participants to use evidence-based behaviour change techniques
5. Encouraging peer support and identification of positive social support outside of the group
6. Providing opportunities for creating a shared social identity and sharing of experiences

The intervention content is detailed in the Facilitator’s Manual and consists of:
1. Information including free online videos and reflective activities to encourage behaviours associated with better health and wellbeing (i.e. CLANGERS)
2. Strategies to support self-regulatory behaviour change techniques (BCTs) – i.e. goal setting, self monitoring, barrier identification and problem solving
3. Encouragement of peer support, identifying sources of support outside of groups, and developing a shared social identity to increase motivation and confidence

The Healthy Parent Carers Guide online materials reflect the content of the group sessions, and provide space to write down reflections, prompts to set specific goals and a self-monitoring diary.

Follow-up: post-intervention and 6 months post-intervention.


Previous interventions:
Method of randomisation: 8-24 participants will be randomised at each of 6 sites when recruitment is completed at each site. A computer-generated randomisation sequence will be used to assign the participants in each site to the intervention and control arms. A block randomisation scheme will be implemented to ensure equal allocations in the number of participants allocated to each trial arm, stratified by group delivery site. The allocation sequence will be concealed from investigators using an online central randomisation service set up and maintained by the Exeter Clinical Trials Unit.

The Healthy Parent Carers programme is a health promotion intervention to improve health and wellbeing for parent carers of disabled children. In this feasibility study, parent carers will be randomised to either a peer-led group-based programme with access to online materials (intervention) or to receiving online materials only (control). The group-based programme content is 12 modules, which can be delivered over six 4-hour or 12 2-hour sessions.

The programme aims to improve health and wellbeing by:
1. Encouraging parent carers to take time to reflect on their health and wellbeing
2. Inspiring motivation and self-efficacy
3. Introducing a set of simple, health-promoting actions with practical examples
4. Prompting participants to use evidence-based behaviour change techniques
5. Encouraging peer support and identification of positive social support outside of the group
6. Providing opportunities for creating a shared social identity and sharing of experiences

The intervention content is detailed in the Facilitator’s Manual and consists of:
1. Information including free online videos and reflective activities to encourage behaviours associated with better health and wellbeing (i.e. CLANGERS)
2. Strategies to support self-regulatory behaviour change techniques (BCTs) – i.e. goal setting, self monitoring, barrier identification and problem solving
3. Encouragement of peer support, identifying sources of support outside of groups, and developing a shared social identity to increase motivation and confidence

The Healthy Parent Carers Guide online materials reflect the content of the group sessions, and provide space to write down reflections, prompts to set specific goals and a self-monitoring diary.

Follow-up: 15 weeks after randomisation and 40 weeks after randomisation (approximately 6 months after the end of the intervention).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current primary outcome measures as of 22/05/2019:
Mental wellbeing is measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline, post-intervention and 6 months post-intervention.

Previous primary outcome measures:
Mental wellbeing is measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation

Secondary outcome measures

Current secondary outcome measures as of 22/05/2019:
1. Depression symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, post-intervention and 6 months post-intervention.
2. Health-related quality of life is measured using the EuroQol 5 Dimensions (EQ-5D-5L) at baseline, post-intervention and 6 months post-intervention.
3. Parental protective factors such as parental resilience, social connections, concrete support in times of need, and support of children’s social and emotional competence are measured using the Parents’ Assessment of Protective Factors (PAPF) at baseline, post-intervention and 6 months post-intervention.
4. Participation in health-promoting activities is measured using the Health Promoting Activities Scale (HPAS) at baseline, post-intervention and 6 months post-intervention.
5. Participants’ management of their own health and care is measured using the Patient Activation Measure (PAM) at baseline, post-intervention and 6 months post-intervention.
6. Health utility in terms of capability including aspects of wellbeing is measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, post-intervention and 6 months post-intervention.
7. Use of health, social care, participant, and broader societal resources is measured using a bespoke Resource Use Questionnaire at baseline, post-intervention and 6 months post-intervention.

Previous secondary outcome measures:
1. Depression symptoms are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
2. Health-related quality of life is measured using the EuroQol 5 Dimensions (EQ-5D-5L) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
3. Parental protective factors such as parental resilience, social connections, concrete support in times of need, and support of children’s social and emotional competence is measured using the Parents’ Assessment of Protective Factors (PAPF) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
4. Participation in health promoting activities is measured using the Health Promoting Activities Scale (HPAS) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
5. Participants’ management of their own health and care is measured using the Patient Activation Measure (PAM) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
6. Health utility in terms of capability including aspects of wellbeing is measured using the ICEpop CAPability measure for Adults (ICECAP-A) at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation
7. Use of health, social care, participant, and broader societal resources is measured using a bespoke Resource Use Questionnaire at baseline, 15 weeks post-randomisation and 40 weeks post-randomisation

Overall trial start date

01/07/2018

Overall trial end date

30/06/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Parent carers of children with special educational needs and disabilities aged up to 25 years consistent with the current UK Department of Health and Department of Education Special Educational Needs & Disability (SEND) legislation and The Children’s Act 2014
2. Willing and able to attend the programme group meeting sessions on arranged dates/times subject to allocation

Participant type

Carer

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 96; UK Sample Size: 96

Total final enrolment

93

Participant exclusion criteria

Not able to communicate in English. This is necessary in the feasibility study because the programme has not yet been translated into other languages and SW England is not ethnically diverse. This criterion will not be used for the national definitive trial as the trialists can translate the programme and purposively recruit in black and minority ethnic communities, for instance in collaboration with Include Me TOO (www.includemetoo.org.uk).

Recruitment start date

29/10/2018

Recruitment end date

20/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Exeter Medical School
South Cloisters, St Luke's Campus University of Exeter
Exeter
EX1 2LU
United Kingdom

Sponsor information

Organisation

University of Exeter

Sponsor details

Research Ethics and Governance Office
Lafrowda House
St Germans Road
Exeter
EX4 4PY
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0317-20044

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Lottery Community Fund

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed, open access, academic journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a publically available repository: Open Research Exeter (ORE) - https://ore.exeter.ac.uk/repository/. Type of data that will be shared: anonymised dataset. When the data will become available and for how long: June 2021; permanently. Data will be shared on reasonable request to the chief investigator.

Intention to publish date

01/06/2021

Participant level data

Stored in repository

Basic results (scientific)

Publication list

2019 protocol in https://www.ncbi.nlm.nih.gov/pubmed/31788323 (added 05/12/2019)

Publication citations

Additional files

Editorial Notes

05/12/2019: Publication reference added. 11/06/2019: The total final enrolment was added. 22/05/2019: The following changes were made: 1. The ClinicalTrials.gov number was added. 2. The National Lottery Community Fund was added as a funder. 3. The plain English summary was updated. 4. The interventions were updated. 5. The outcome measures were updated.