Clinical trial NCT03705221: Healthy Parent Carers Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2018-10-15
Enrollment: 93
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Warwick-Edinburgh Mental Well-being Scale
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Warwick-Edinburgh Mental Well-being Scale
timeFrame: Baseline
measure: Warwick-Edinburgh Mental Well-being Scale
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: EQ-5D-5L
timeFrame: Baseline
measure: EQ-5D-5L
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: EQ-5D-5L
timeFrame: 6 months post-intervention
measure: PHQ-9
timeFrame: Baseline
measure: PHQ-9
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: PHQ-9
timeFrame: 6 months post-intervention
measure: Health Promoting Activities Scale
timeFrame: Baseline
measure: Health Promoting Activities Scale
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: Health Promoting Activities Scale
timeFrame: 6 months post-intervention
measure: Patient Activation Measure (PAM)
timeFrame: Baseline
measure: Patient Activation Measure (PAM)
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: Patient Activation Measure (PAM)
timeFrame: 6 months post-intervention
measure: Parents' Assessment of Protective Factors
timeFrame: Baseline
measure: Parents' Assessment of Protective Factors
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: Parents' Assessment of Protective Factors
timeFrame: 6 months post-intervention
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: Baseline
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: ICEpop CAPability measure for Adults (ICECAP-A)
timeFrame: 6 months post-intervention
measure: Service and Resource Use questionnaire
timeFrame: Baseline
measure: Service and Resource Use questionnaire
timeFrame: Immediately post-intervention (up to 12 weeks)
measure: Service and Resource Use questionnaire
timeFrame: 6 months post-intervention
measure: Programme Feedback Form
timeFrame: Immediately post-intervention (up to 12 weeks)
Other outcomes:
Locations:
city: Saint Austell
country: United Kingdom
facility: Children's Hospice South West Little Harbour
state: Cornwall
city: Bideford
country: United Kingdom
facility: Learn Devon Bideford
state: Devon
city: Dawlish
country: United Kingdom
facility: Orchard Manor School
state: Devon
city: Plymouth
country: United Kingdom
facility: Woodlands School
state: Devon
city: Torquay
country: United Kingdom
facility: Torbay Parent Carer Forum
state: Devon
city: Minehead
country: United Kingdom
facility: The Beach Hotel
state: Somerset
Study officials:
affiliation: University of Exeter
name: Chris Morris, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.