Circle of Security™ for mentally ill women with their infants
| ISRCTN | ISRCTN88988596 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88988596 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/02/2010
- Registration date
- 07/06/2010
- Last edited
- 04/09/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Brigitte Ramsauer
Scientific
Scientific
Martinistr. 52
Hamburg
20246
Germany
| Phone | +49 (0)40 7410 55839 |
|---|---|
| b.ramsauer@uke.uni-hamburg.de |
Study information
| Study design | Single-centre randomised controlled evaluation trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled evaluation of an attachment-based group intervention program (Circle of Security™) for mentally ill women with their infants |
| Study acronym | RCT COSI |
| Study objectives | Circle of Security™ (COS) intervention will lead to significantly more securely attached infants compared to treatment as usual intervention. |
| Ethics approval(s) | Ethics Committee of the Medical Association of Hamburg, 24/08/2009, ref: PV3269 |
| Health condition(s) or problem(s) studied | Maternal mental illness, attachment disorders |
| Intervention | COS Intervention: The Circle of Security™ (COS) intervention was designed to alter developmental pathways of at-risk parents and their children. Conceptualised as a manualised, group-based, 20-week intervention program, the focus is on the care-giver and his relationship capacities, to enhance the quality of child-parent attachment. Duration of treatment: 7 months TAU: Standard treatment practice at the mother-infant unit at the Department of Child and Adolescent Psychiatry at the University Medical Center of Hamburg. Duration of treatment: variable duration Timepoints of assessments: T1: Pre-treatment T2: Post-treatment (child's age 16 - 18 months) |
| Intervention type | Other |
| Primary outcome measure | Infant's attachment quality (security versus insecurity), measured at T2 |
| Secondary outcome measures | 1. Mother's attachment representation, measured at T1 and T2 2. Mother's interaction behaviour, measured at T1 and T2 3. Mother's reflecting functioning (RF), measured at T1 and T2 4. Mother's symptomatology, measured at T1 and T2 |
| Overall study start date | 01/01/2010 |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | N = 72 |
| Key inclusion criteria | 1. Mother (no age restrictions): mental illness 2. Infant: age of 4 to 9 months at study inclusion, either sex |
| Key exclusion criteria | 1. Mother: 1.1. Acute crisis of mental illness (i.e. suicidal tendency) 1.2. Schizophrenia 1.3. Primary substance-abuse 1.4. Intellectual impairments (intelligence quotient [IQ] less than 80) 2. Infant: 2.1. Mental retardation 2.2. Autism |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Martinistr. 52
Hamburg
20246
Germany
20246
Germany
Sponsor information
Hamburg Foundation for the Advancement for Research and Culture (Germany)
Research organisation
Research organisation
c/o Mera GmbH
Große Bleichen 8
Hamburg
20354
Germany
| Website | http://www.his-online.de/ |
|---|---|
"ROR" |
https://ror.org/03ec28972 |
Funders
Funder type
Research organisation
Hamburg Foundation for the Advancement for Research and Culture (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 30/01/2014 | Yes | No |
