An interventional study of FACAM and Care as Usual in At-risk Pregnant Women, sponsored by VIVE - The Danish Center for Social Science Research. Completed at 2 sites in Denmark. Open to female participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-11-13.
Sponsored by VIVE - The Danish Center for Social Science Research · Not applicable, Interventional, and Prevention
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.
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.
VIVE - The Danish Center for Social Science Research is the lead sponsor of 10 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: FACAM · Behavioral: COS-P
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.
Behavioral: Care as Usual
Support person
Usual care
Attachment based therapy
Maternal sensitivity
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Time frame: at child age 12 months
Maternal Sensitivity
Maternal sensitivity measured by the CIB (Coding Interactive Behavior)
Time frame: at child age 3 months
Coding interactive bahavior (CIB)
Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states
Time frame: child age 3 and 12 months
Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)
Child social-emotional Development Total score range 0-150 ( 3 months 15 items), 0-260 (12 months 26 items). Low score is better.
Time frame: child age 3 and 12 months
Edinburgh Postnatal depression Scale (EPDS)
Depression Total score range 0-30. Low score is better
Time frame: child age 3 and 12 months
Warwick-Edinburgh Mental Well-being Scale
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.
Time frame: child age 3 and 12 months
Prenatal Parental reflective functioning questionnaire (P-PRFQ)
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)
Time frame: Baseline
Parental reflective functioning questionnaire (PRFQ-1)
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.
Time frame: child age 12 months
Parental Stress Scale (PSS)
Parental stress Total score range 18-90 low score is better
Time frame: Cild age 3 and 12 months
Ages and Stages Questionnaire 3 (ASQ:3)
Child development
Time frame: child age 3 months
Activities with child
Singing and reading Total score range 0-70. High score is better.
Time frame: child age 12 months
Being a Mother (BAM-13)
Maternal confidence. Total score range 0-39. Low score is better
Time frame: child age 3 and 12 months
Hospital Anxiety and Depression Scale (HADS)
Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)
Time frame: Baseline, 3 and 12 months
Experiences in Close Relationship Scale-Short Form (ECR-S)
Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)
Time frame: Baseline
Plan to share: Undecided — Study protocol and analysis plan will be available
This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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VIVE - The Danish Center for Social Science Research