The Effects of Family Clinic and Municipality (FACAM)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- At-risk Pregnant Women
- Sponsor
- VIVE - The Danish Center for Social Science Research
- Enrollment
- 332
- Locations
- 2
- Primary Endpoint
- Maternal sensitivity
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Maternal sensitivity
Time Frame: at child age 12 months
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Secondary Outcomes
- Warwick-Edinburgh Mental Well-being Scale(child age 3 and 12 months)
- Experiences in Close Relationship Scale-Short Form (ECR-S)(Baseline)
- Maternal Sensitivity(at child age 3 months)
- Edinburgh Postnatal depression Scale (EPDS)(child age 3 and 12 months)
- Prenatal Parental reflective functioning questionnaire (P-PRFQ)(Baseline)
- Parental Stress Scale (PSS)(Cild age 3 and 12 months)
- Being a Mother (BAM-13)(child age 3 and 12 months)
- Hospital Anxiety and Depression Scale (HADS)(Baseline, 3 and 12 months)
- Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)(child age 3 and 12 months)
- Parental reflective functioning questionnaire (PRFQ-1)(child age 12 months)
- Ages and Stages Questionnaire 3 (ASQ:3)(child age 3 months)
- Coding interactive bahavior (CIB)(child age 3 and 12 months)
- Activities with child(child age 12 months)