The Effects of Family Clinic and Municipality (FACAM)

VIVE - The Danish Center for Social Science Research

Status: Completed

Conditions: At-risk Pregnant Women

Treatments: Behavioral: FACAM; Behavioral: Care as Usual; Behavioral: COS-P

Study type: Interventional

Funder types: Other

Identifiers

NCT03659721

VIVE 100750-751

Details and patient eligibility

About

This trial is a randomized controlled trial with the aim is to assess the effectiveness of Family Clinic and Municipality (FACAM) to improve mother-child relationship, maternal health, maternal mental health, and the development and well-being of the child.

Full description

Pregnant women who struggle with psychosocial challenges during pregnancy have a higher risk of preterm birth, giving birth to a child with low birth weight and a higher risk of complications during pregnancy both for mother and child. An early and coordinated intervention to reduce inequality in health may be important for this group of vulnerable women.

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.

Enrollment: 332 patients

Sex: Female

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women admitted to the Familieambulatorium, and living in Odense municipality
• Antenatal care group 3 or 4 according to the Danish health authorities' recommendations

Exclusion criteria

• Life-threatening illness in parent or child
• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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332 participants in 2 patient groups

FACAM

Experimental group

Description:

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.

Treatment:

Behavioral: COS-P

Behavioral: FACAM

Care as Usual

Active Comparator group

Description:

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.

Treatment:

Behavioral: Care as Usual