The Effects of Family Clinic and Municipality

At-risk Pregnant Women Clinical Trial

— FACAM  

Official title:

The Effects of Family Clinic and Municipality (FACAM)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03659721
• Other study ID #: VIVE 100750-751
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: February 2023
• Source: VIVE - The Danish Center for Social Science Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 332
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• At-risk Pregnant Women

Intervention

Behavioral:
• FACAM
Support person
• Care as Usual
Usual care
• COS-P
Attachment based therapy

Locations

Country	Name	City	State
Denmark	VIVE - The Danish Centre of Social Science Research	Copenhagen
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
VIVE - The Danish Center for Social Science Research	Odense Kommune, Odense Patient Data Explorative Network, Odense University Hospital, Syddansk Universitet

Country where clinical trial is conducted

Denmark, 

Outcome

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