Plain English Summary

Not provided at time of registration

Trial website

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 approved on the 24th August 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

Other

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

http://www.his-online.de/

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

Publication citations

Editorial Notes