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
Abstract Background Perinatal mental health difficulties affect up to 27% of birthing parents during pregnancy and the first postnatal year, and if untreated are associated with difficulties in bonding and long-term adverse outcomes to children. There are large evidence gaps related to psychological...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07194-3 |
| _version_ | 1797863621511872512 |
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| author | Camilla Rosan Kim Alyousefi-van Dijk Zoe Darwin Daphne Babalis Victoria Cornelius Rachel Phillips Lani Richards Hannah Wright Steve Pilling Pasco Fearon Elena Pizzo Peter Fonagy |
| author_facet | Camilla Rosan Kim Alyousefi-van Dijk Zoe Darwin Daphne Babalis Victoria Cornelius Rachel Phillips Lani Richards Hannah Wright Steve Pilling Pasco Fearon Elena Pizzo Peter Fonagy |
| author_sort | Camilla Rosan |
| collection | DOAJ |
| description | Abstract Background Perinatal mental health difficulties affect up to 27% of birthing parents during pregnancy and the first postnatal year, and if untreated are associated with difficulties 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 efficacious findings and user acceptability is Circle of Security-Parenting (COS-P), which is a brief, weekly, group programme. However, these studies were underpowered 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 difficulties. 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 staff, and whether it is cost-effective. 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 difficulties (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 first large pragmatic trial to test whether COS-P is effective for birthing parents with severe and complex perinatal mental health difficulties in improving their mental health symptoms. If shown to be effective, the intervention could be delivered widely across the NHS and other similar services globally. Trial registration ISRCTN, ISRCTN18308962. Registered 18 February 2022. |
| first_indexed | 2024-04-09T22:39:34Z |
| format | Article |
| id | doaj.art-a0d05f650b614daaa2521a49173e000c |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:34Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-a0d05f650b614daaa2521a49173e000c2023-03-22T12:17:37ZengBMCTrials1745-62152023-03-0124111710.1186/s13063-023-07194-3The 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 EnglandCamilla Rosan0Kim Alyousefi-van Dijk1Zoe Darwin2Daphne Babalis3Victoria Cornelius4Rachel Phillips5Lani Richards6Hannah Wright7Steve Pilling8Pasco Fearon9Elena Pizzo10Peter Fonagy11Department of Clinical, Educational and Health Psychology, University College LondonAnna Freud National Centre for Children and FamiliesUniversity of HuddersfieldImperial Clinical Trials Unit, School of Public Health, Imperial College LondonImperial Clinical Trials Unit, School of Public Health, Imperial College LondonImperial Clinical Trials Unit, School of Public Health, Imperial College LondonAnna Freud National Centre for Children and FamiliesDepartment of Clinical, Educational and Health Psychology, University College LondonDepartment of Clinical, Educational and Health Psychology, University College LondonDepartment of Clinical, Educational and Health Psychology, University College LondonDepartment of Applied Health Research, University College LondonDepartment of Clinical, Educational and Health Psychology, University College LondonAbstract Background Perinatal mental health difficulties affect up to 27% of birthing parents during pregnancy and the first postnatal year, and if untreated are associated with difficulties 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 efficacious findings and user acceptability is Circle of Security-Parenting (COS-P), which is a brief, weekly, group programme. However, these studies were underpowered 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 difficulties. 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 staff, and whether it is cost-effective. 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 difficulties (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 first large pragmatic trial to test whether COS-P is effective for birthing parents with severe and complex perinatal mental health difficulties in improving their mental health symptoms. If shown to be effective, the intervention could be delivered widely across the NHS and other similar services globally. Trial registration ISRCTN, ISRCTN18308962. Registered 18 February 2022.https://doi.org/10.1186/s13063-023-07194-3Perinatal mental healthCircle of Security-ParentingParent-infant bondingChild developmentChild attachmentRandomised controlled trial |
| spellingShingle | Camilla Rosan Kim Alyousefi-van Dijk Zoe Darwin Daphne Babalis Victoria Cornelius Rachel Phillips Lani Richards Hannah Wright Steve Pilling Pasco Fearon Elena Pizzo Peter Fonagy 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 Perinatal mental health Circle of Security-Parenting Parent-infant bonding Child development Child attachment Randomised controlled trial |
| 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Perinatal mental health Circle of Security-Parenting Parent-infant bonding Child development Child attachment Randomised controlled trial |
| url | https://doi.org/10.1186/s13063-023-07194-3 |
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