The COSI Study
Research type
Research Study
Full title
The COSI study: a multi-site randomised controlled trial (RCT) to explore the clinical and cost effectiveness of the Circle of Security Intervention for mothers in perinatal mental health services.
IRAS ID
303294
Contact name
Camilla Rosan
Contact email
Sponsor organisation
Anna Freud National Centre for Children and Families
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The COSI study is a randomised controlled trial to explore the clinical and cost effectiveness of a 10-week, group-based intervention called Circle of Security Parenting (COS-P) for women in NHS perinatal mental health services (PMHS).
COS-P is a group-based intervention designed to help parents understand more about their babies and their emotional states, as well as manage their own difficult emotions and how they may affect their relationship with their babies. The trial will involve nine PMHS across England and will compare COS-P to treatment as usual with a sample of 369 participants.
The primary aims are to identify effectiveness of COS-P in improving symptoms of maternal mental illness compared to parents receiving treatment as usual. Maternal mental health will be measured using the Clinical Outcomes in Routine Evaluation -Outcome Measure (CORE-OM), a self-report survey that participants will complete before they begin the intervention (baseline) and 3-months, 7-months and 12-months after the intervention (follow-up). Secondary outcomes assessed will include maternal sensitivity, emotional regulation skills, attachment security and infant development. All outcomes will be measured through questionnaires and parent-infant observations. We will also interview parents to explore their experiences of receiving COS-P and conduct focus groups with PMHS staff to explore their views of facilitating COS-P.
The study is the first large study to test whether a brief group therapy intervention is effective for women using PMHS in improving symptoms of mental illness and the quality of their bond with their babies. It addresses an area of key concern to women, families and the NHS and will substantially add to the evidence base for psychological interventions that target maternal mental health problems and mother-infant relationship quality. If effective, the research will lead to improved short- and long-term outcomes for mothers and children across a range of domains.
REC name
London - Surrey Research Ethics Committee
REC reference
21/LO/0723
Date of REC Opinion
26 Nov 2021
REC opinion
Further Information Favourable Opinion