Rosan, Camilla;
Alyousefi-van Dijk, Kim;
Darwin, Zoe;
Babalis, Daphne;
Cornelius, Victoria;
Phillips, Rachel;
Richards, Lani;
... Fonagy, Peter; + view all
(2023)
The COSI trial: a study protocol for a multi-centre, randomised controlled trial to explore the clinical and cost effectiveness of the Circle of Security-Parenting Intervention in community perinatal mental health services in England.
Trials
, 24
, Article 188.
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Abstract
Background Perinatal mental health difculties afect up to 27% of birthing parents during pregnancy and the frst postnatal year, and if untreated are associated with difculties in bonding and long-term adverse outcomes to children. There are large evidence gaps related to psychological treatment, particularly in group therapy approaches and parent-infant interventions. One intervention showing preliminary efcacious fndings and user acceptability is Circle of Security-Parenting (COS-P), which is a brief, weekly, group programme. However, these studies were under‑ powered and predominantly non-randomised, and there has never been a research trial in England or with birthing parents experiencing severe and complex perinatal mental health difculties. The aim of the research is to conduct a randomised control trial to test whether COS-P will reduce perinatal mental health symptoms in birthing parents accessing NHS perinatal mental health services, compared to treatment as usual (TAU). Secondary objectives include exploring whether the intervention improves parenting sensitivity, emotion regulation skills, attachment security and infant development. Additionally, the project aims to examine whether the intervention is acceptable to parents and NHS staf, and whether it is cost-efective. Methods COSI is an individually randomised, single-blind parallel arm controlled trial with an embedded internal pilot aiming to recruit 369 participants in a 2:1 ratio (intervention: TAU). Participants will be recruited from ten NHS community perinatal mental health services in England and screened based on clinical levels of both mental health symptoms (average CORE-OM score≥1.1) and postnatal bonding difculties (total PBQ score≥12). This trial has 90% power to detect a MCID of 5 points on the CORE-OM. Primary and secondary outcomes will be measured at baseline, 3, 7 and 12 months after baseline. Service use and quality of life measures will also be collected alongside a process evaluation of parents’ and interveners’ views and experiences.Discussion This will be the frst large pragmatic trial to test whether COS-P is efective for birthing parents with severe and complex perinatal mental health difculties in improving their mental health symptoms. If shown to be efective, the intervention could be delivered widely across the NHS and other similar services globally. Trial registration ISRCTN, ISRCTN18308962. Registered 18 February 2022.
| Type: | Article |
|---|---|
| Title: | The COSI trial: a study protocol for a multi-centre, randomised controlled trial to explore the clinical and cost effectiveness of the Circle of Security-Parenting Intervention in community perinatal mental health services in England |
| Open access status: | An open access version is available from UCL Discovery |
| Publisher version: | 10.1186/s13063-023-07194-3 |
| Language: | English |
| Additional information: | Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
| Keywords: | Perinatal mental health, Circle of Security-Parenting, Parent-infant bonding, Child development, Child attachment, Randomised controlled trial |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Epidemiology and Health > Applied Health Research |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10165322 |
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