The Effects of Family Clinic and Municipality

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Effects of Family Clinic and Municipality (FACAM)

Conditions
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At-risk Pregnant Women

Intervention / Treatment
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* Behavioral: FACAM
* Behavioral: Care as Usual
* Behavioral: COS-P


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FACAM<br>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<br>* Support person<br>Behavioral: COS-P<br>* Attachment based therapy<br>|
| Active Comparator: Care as Usual<br>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<br>* Usual care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal sensitivity | Maternal sensitivity measured by the CIB (Coding Interactive Behavior) | at child age 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal Sensitivity | Maternal sensitivity measured by the CIB (Coding Interactive Behavior) | at child age 3 months | 
| Coding interactive bahavior (CIB) | Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states | 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. | child age 3 and 12 months | 
| Edinburgh Postnatal depression Scale (EPDS) | Depression Total score range 0-30. Low score is better | 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. | 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) | 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. | child age 12 months | 
| Parental Stress Scale (PSS) | Parental stress Total score range 18-90 low score is better | Cild age 3 and 12 months | 
| Ages and Stages Questionnaire 3 (ASQ:3) | Child development | child age 3 months | 
| Activities with child | Singing and reading Total score range 0-70. High score is better. | child age 12 months | 
| Being a Mother (BAM-13) | Maternal confidence. Total score range 0-39. Low score is better | 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) | 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) | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnant, Infant, Parent, Family, Mother, Support