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Circle of Security™ for mentally ill women with their infants
ISRCTN ISRCTN88988596
DOI 10.1186/ISRCTN88988596
ClinicalTrials.gov identifier
EudraCT number
Public title Circle of Security™ for mentally ill women with their infants
Scientific title A randomised controlled evaluation of an attachment-based group intervention program (Circle of Security™) for mentally ill women with their infants
Acronym RCT COSI
Serial number at source N/A
Study hypothesis Circle of Security™ (COS) intervention will lead to significantly more securely attached infants compared to treatment as usual intervention.
Lay summary
Ethics approval Ethics Committee of the Medical Association of Hamburg approved on the 24th August 2009 (ref: PV3269)
Study design Single centre randomised controlled evaluation trial
Countries of recruitment Germany
Disease/condition/study domain Maternal mental illness, attachment disorders
Participants - inclusion criteria 1. Mother (no age restrictions): mental illness
2. Infant: age of 4 to 9 months at study inclusion, either sex
Participants - 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
Anticipated start date 01/01/2010
Anticipated end date 31/12/2011
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants N = 72
Interventions 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)
Primary outcome measure(s) Infant's attachment quality (security versus insecurity), measured at T2
Secondary outcome measure(s) 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
Sources of funding Hamburg Foundation for the Advancement for Research and Culture (Germany)
Trial website
Publications
Contact name Dr  Brigitte  Ramsauer
  Address Martinistr. 52
  City/town Hamburg
  Zip/Postcode 20246
  Country Germany
  Tel +49 (0)40 7410 55839
  Fax +49 (0)40 7410 52409
  Email b.ramsauer@uke.uni-hamburg.de
Sponsor Hamburg Foundation for the Advancement for Research and Culture (Germany)
  Address c/o Mera GmbH
Große Bleichen 8
  City/town Hamburg
  Zip/Postcode 20354
  Country Germany
  Sponsor website: http://www.his-online.de/
Date applied 04/02/2010
Last edited 07/06/2010
Date ISRCTN assigned 07/06/2010
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