At-risk Pregnant Women
Conditions
Keywords
Pregnant, Infant, Parent, Family, Mother, Support
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.
Interventions
BEHAVIORALFACAM
Support person
BEHAVIORALCare as Usual
Usual care
BEHAVIORALCOS-P
Attachment based therapy
Sponsors
Odense University Hospital
Syddansk Universitet
Odense Patient Data Explorative Network
Odense Kommune
VIVE - The Danish Center for Social Science Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
As the participants are offered extra support as the intervention neither participants nor care providers can be blinded. Outcome assessor and data analyst will be blinded.
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.
Eligibility
Sex/Gender
FEMALE
Age
15 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal sensitivity | at child age 12 months | Maternal sensitivity measured by the CIB (Coding Interactive Behavior) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Coding interactive bahavior (CIB) | child age 3 and 12 months | Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states |
| Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2) | child age 3 and 12 months | Child social-emotional Development Total score range 0-150 ( 3 months 15 items), 0-260 (12 months 26 items). Low score is better. |
| Edinburgh Postnatal depression Scale (EPDS) | child age 3 and 12 months | Depression Total score range 0-30. Low score is better |
| Warwick-Edinburgh Mental Well-being Scale | child age 3 and 12 months | Maternal mental Health 7 items. A total score i calculated by summing the 7 items and converting the raw score according to a published conversion table. Raw score range 7- 35. Converted score range 7-35. High is better outcome. |
| Prenatal Parental reflective functioning questionnaire (P-PRFQ) | Baseline | Parental reflective functioning for pregnant women. Total score range 14-98. Higher score is better. Three subscales: Opacity of mental states (4 items), reflecting on the fetus-baby (3 items) and Dynamic of mental states (5 items) |
| Parental reflective functioning questionnaire (PRFQ-1) | child age 12 months | Parental reflective functioning Three subscales score range 6-42: Pre-Mentalizing Modes (PRFQ-PM) 6 items. low score is better. Certainty about Mental States (PRFQ-CMS) 6 items high score is better. Interest and curiosity in mental states PRFQ-IC 6 items high score is better. |
| Maternal Sensitivity | at child age 3 months | Maternal sensitivity measured by the CIB (Coding Interactive Behavior) |
| Ages and Stages Questionnaire 3 (ASQ:3) | child age 3 months | Child development |
| Activities with child | child age 12 months | Singing and reading Total score range 0-70. High score is better. |
| Being a Mother (BAM-13) | child age 3 and 12 months | Maternal confidence. Total score range 0-39. Low score is better |
| Hospital Anxiety and Depression Scale (HADS) | Baseline, 3 and 12 months | Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better) |
| Experiences in Close Relationship Scale-Short Form (ECR-S) | Baseline | Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better) |
| Parental Stress Scale (PSS) | Cild age 3 and 12 months | Parental stress Total score range 18-90 low score is better |
Countries
Denmark
Outcome results
None listed