Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children.

Journal

Pilot and feasibility studies
ISSN: 2055-5784
Titre abrégé: Pilot Feasibility Stud
Pays: England
ID NLM: 101676536

Informations de publication

Date de publication:
2021
Historique:
received: 10 03 2021
accepted: 02 07 2021
entrez: 24 7 2021
pubmed: 25 7 2021
medline: 25 7 2021
Statut: epublish

Résumé

Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. ISRCTN, ISRCTN15144652 , registered on 25 October 2018, ClinicalTrials.gov , NCT03705221 , registered on 15 October 2018.

Sections du résumé

BACKGROUND
Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design.
METHODS
Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design.
RESULTS
One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up.
CONCLUSIONS
The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties.
TRIAL REGISTRATION
ISRCTN, ISRCTN15144652 , registered on 25 October 2018, ClinicalTrials.gov , NCT03705221 , registered on 15 October 2018.

Identifiants

DOI: 10.1186/s40814-021-00881-5 PMID: 34301334 PMC: PMC8298691
pubmed: 34301334
doi: 10.1186/s40814-021-00881-5
pii: 10.1186/s40814-021-00881-5
pmc: PMC8298691
doi:

Banques de données

ClinicalTrials.gov
['NCT03705221']

Types de publication

Journal Article

Langues

eng

Pagination

144

Subventions

Organisme : Research for Patient Benefit Programme
ID : PB-PG-0317-20044
Organisme : National Lottery Community Fund
ID : 10343962

Informations de copyright

© 2021. The Author(s).

Déclaration de conflit d'intérêts

Competing interestsThe authors declare that they have no competing interests.

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Auteurs

Gretchen Bjornstad (G)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. g.j.bjornstad@exeter.ac.uk.
NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. g.j.bjornstad@exeter.ac.uk.
ORCID: 0000-0003-4456-787X

Beth Cuffe-Fuller (B)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Obioha C Ukoumunne (OC)

NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Mary Fredlund (M)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Annabel McDonald (A)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Kath Wilkinson (K)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Jenny Lloyd (J)

NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
Relational Health Group, Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, EX1 2LU, UK.

Annie Hawton (A)

NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
Health Economics Group and NIHR Applied Research Collaboration (PenARC) South West Peninsula, University of Exeter Medical School, University of Exeter, Exeter, EX1 2LU, UK.

Vashti Berry (V)

NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Mark Tarrant (M)

NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Aleksandra Borek (A)

Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.

Katharine Fitzpatrick (K)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Annette Gillett (A)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Shelley Rhodes (S)

Exeter Clinical Trials Unit, University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Stuart Logan (S)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Christopher Morris (C)

Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
NIHR Applied Research Collaboration South West Peninsula (PenARC), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.

Classifications MeSH