Clinical trial NCT03659721: The Effects of Family Clinic and Municipality
Official title: The Effects of Family Clinic and Municipality (FACAM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: At-risk Pregnant Women
Keywords: Pregnant
Infant
Parent
Family
Mother
Support
Lead sponsor: VIVE - The Danish Center for Social Science Research
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Syddansk Universitet
name: Odense Patient Data Explorative Network
name: Odense Kommune
First posted: 2018-09-06
Enrollment: 332
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a prospective randomized controlled trial with two study arms: intervention (FACAM) and care as usual (CAU). Pregnant women are randomized to receive either FACAM or CAU.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maternal sensitivity
timeFrame: at child age 12 months
Secondary outcomes:
measure: Maternal Sensitivity
timeFrame: at child age 3 months
measure: Coding interactive bahavior (CIB)
timeFrame: child age 3 and 12 months
measure: Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)
timeFrame: child age 3 and 12 months
measure: Edinburgh Postnatal depression Scale (EPDS)
timeFrame: child age 3 and 12 months
measure: Warwick-Edinburgh Mental Well-being Scale
timeFrame: child age 3 and 12 months
measure: Prenatal Parental reflective functioning questionnaire (P-PRFQ)
timeFrame: Baseline
measure: Parental reflective functioning questionnaire (PRFQ-1)
timeFrame: child age 12 months
measure: Parental Stress Scale (PSS)
timeFrame: Cild age 3 and 12 months
measure: Ages and Stages Questionnaire 3 (ASQ:3)
timeFrame: child age 3 months
measure: Activities with child
timeFrame: child age 12 months
measure: Being a Mother (BAM-13)
timeFrame: child age 3 and 12 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Baseline, 3 and 12 months
measure: Experiences in Close Relationship Scale-Short Form (ECR-S)
timeFrame: Baseline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: VIVE - The Danish Centre of Social Science Research
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: VIVE
name: Maiken Pontoppidan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.