Healthy Parent Carers Feasibility Study

University of Exeter

Status: Completed

Conditions: Health Behavior

Treatments: Behavioral: Healthy Parent Carers group programme; Behavioral: Healthy Parent Carers online resources

Study type: Interventional

Funder types: Other

Identifiers

NCT03705221

NIHR RfPB PB-PG-0317-20044

246169 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Group programme

Experimental group

Description:

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.

Treatment:

Behavioral: Healthy Parent Carers group programme

Online resources

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy Parent Carers online resources