Contact information
Type
Scientific
Primary contact
Dr Brigitte Ramsauer
ORCID ID
Contact details
Martinistr. 52
Hamburg
20246
Germany
+49 (0)40 7410 55839
b.ramsauer@uke.uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Study hypothesis
Circle of Security™ (COS) intervention will lead to significantly more securely attached infants compared to treatment as usual intervention.
Ethics approval
Ethics Committee of the Medical Association of Hamburg, 24/08/2009, ref: PV3269
Study design
Single-centre randomised controlled evaluation trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
01/01/2010
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. Mother (no age restrictions): mental illness
2. Infant: age of 4 to 9 months at study inclusion, either sex
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
N = 72
Participant 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
Recruitment start date
01/01/2010
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Martinistr. 52
Hamburg
20246
Germany
Sponsor information
Organisation
Hamburg Foundation for the Advancement for Research and Culture (Germany)
Sponsor details
c/o Mera GmbH
Große Bleichen 8
Hamburg
20354
Germany
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Hamburg Foundation for the Advancement for Research and Culture (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24476106