Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
332 participants
INTERVENTIONAL
2018-10-01
2023-11-30
Brief Summary
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Detailed Description
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The FACAM intervention is developed in Odense with the aim of reducing inequality in health by giving vulnerable pregnant women and their children the best possible start in life by offering an interdisciplinary coordinated support. The support will be offered by Odense municipality, the family clinic (Familieambulatoriet), and local voluntary organizations.
The aim of the trial is to assess the effectiveness of FACAM to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.
The study is a Randomized Controlled Trial (RCT). A total of 320 pregnant women will be randomized to FACAM or Care as Usual.
Participants are pregnant women categorized as antenatal care group 3 or 4, living in Odense and with a referral to Familieambulatoriet, OUH. Participants must be able to fill out questionnaires in Danish or English.
Data will be collected at baseline (pregnancy), and when the child is 3 and 12 months old.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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FACAM
Intervention participants are assigned a support person (health nurse or a family therapist) who will offer support to the family until the child starts school at age 6. Intensity is up to 37 hours the first year followed by up to 10 hours of support each of the following years. The support person will offer individualized support to the family depending on the needs of the family. The support person will attend midwife consultations and help the pregnant woman to attend consultations with e.g. GP, midwife, or social worker. All intervention participants will also receive either an individual or group-based (COS-P)attachment based intervention during pregnancy and the first months of the child's life.
FACAM
Support person
COS-P
Attachment based therapy
Care as Usual
Families in the control group receive the usual care that is offered to families in the target group. This includes consultations with e.g. a midwife, social worker, medical doctor, and health visitor. If needed, CAU families can receive e.g. extra home visits or family therapy.
Care as Usual
Usual care
Interventions
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FACAM
Support person
Care as Usual
Usual care
COS-P
Attachment based therapy
Eligibility Criteria
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Inclusion Criteria
* Antenatal care group 3 or 4 according to the Danish health authorities' recommendations
Exclusion Criteria
* Not able to fill out questionnaires in Danish or English
* Child in out of home care after birth
* Pregnancy with twins
* Previous participation in the FACAM project
15 Years
FEMALE
No
Sponsors
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Odense University Hospital
OTHER
Syddansk Universitet
UNKNOWN
Odense Patient Data Explorative Network
OTHER
Odense Kommune
UNKNOWN
VIVE - The Danish Center for Social Science Research
OTHER
Responsible Party
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Principal Investigators
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Maiken Pontoppidan, PhD
Role: PRINCIPAL_INVESTIGATOR
VIVE
Locations
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VIVE - The Danish Centre of Social Science Research
Copenhagen, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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Pontoppidan M, Nygaard L, Thorsager M, Friis-Hansen M, Davis D, Nohr EA. The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood. Trials. 2022 Jan 24;23(1):73. doi: 10.1186/s13063-022-06022-4.
Other Identifiers
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VIVE 100750-751
Identifier Type: -
Identifier Source: org_study_id
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