Gretchen Bjornstad1,2, Beth Cuffe-Fuller3, Obioha C Ukoumunne4, Mary Fredlund3,4, Annabel McDonald3, Kath Wilkinson3, Jenny Lloyd4,5, Annie Hawton4,6, Vashti Berry4, Mark Tarrant4, Aleksandra Borek7, Katharine Fitzpatrick3, Annette Gillett3, Shelley Rhodes8, Stuart Logan3,4, Christopher Morris3,4. 1. 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. 2. 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. 3. Peninsula Childhood Disability Research Unit (PenCRU), University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK. 4. 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. 5. Relational Health Group, Institute of Health Research, University of Exeter Medical School, University of Exeter, Exeter, EX1 2LU, UK. 6. Health Economics Group and NIHR Applied Research Collaboration (PenARC) South West Peninsula, University of Exeter Medical School, University of Exeter, Exeter, EX1 2LU, UK. 7. Nuffield Department of Primary Care Health Sciences, Medical Sciences Division, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. 8. Exeter Clinical Trials Unit, University of Exeter Medical School, University of Exeter, St. Luke's Campus, Heavitree Road, Exeter, EX1 2LU, UK.
Abstract
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.
RCT Entities:
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.
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