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At-risk Pregnant WomenFACAMNCT03659721

The Effects of Family Clinic and Municipality

A study testing FACAM, Care as Usual and COS-P in people with At-risk Pregnant Women, run by VIVE - The Danish Center for Social Science Research at 2 sites in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 15 years and older, women only
Conditions the study is for
At-risk Pregnant Women
What is being tested?
FACAM, Care as Usual and COS-P
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
2 sitesDenmark
Study dates
1 Oct 2018to 30 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Pregnant women admitted to the Familieambulatorium, and living in Odense municipality
  • Antenatal care group 3 or 4 according to the Danish health authorities' recommendations

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Denmark2 sites

  • VIVE - The Danish Centre of Social Science Research

    Copenhagen, 1052

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

About this study

Official title: The Effects of Family Clinic and Municipality (FACAM)

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.

Read the 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.

Being tested
FACAM, Care as Usual, COS-P
Keywords
Pregnant, Infant, Parent, Family, Mother, Support

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FACAMBehavioural

    Support person

  • Care as UsualBehavioural

    Usual care

  • COS-PBehavioural

    Attachment based therapy

Study groups in NCT03659721
Study groupRoleWhat they receive
FACAMExperimentalIntervention 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.
Receives: Behavioral: FACAM; Behavioral: COS-P
Care as UsualActive comparatorFamilies 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.
Receives: Behavioral: Care as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal sensitivity

    Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Measured: at child age 12 months

Secondary outcomes (13)

  1. Maternal Sensitivity

    Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

    Measured: at child age 3 months

  2. Coding interactive bahavior (CIB)

    Parent child relationship Subscales: Intrusiveness, Limit setting, Involvement, Withdrawal, Reciprocity, Negative states

    Measured: child age 3 and 12 months

  3. 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.

    Measured: child age 3 and 12 months

  4. Edinburgh Postnatal depression Scale (EPDS)

    Depression Total score range 0-30. Low score is better

    Measured: child age 3 and 12 months

  5. 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.

    Measured: child age 3 and 12 months

  6. 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)

    Measured: Baseline

  7. 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.

    Measured: child age 12 months

  8. Parental Stress Scale (PSS)

    Parental stress Total score range 18-90 low score is better

    Measured: Cild age 3 and 12 months

  9. Ages and Stages Questionnaire 3 (ASQ:3)

    Child development

    Measured: child age 3 months

  10. Activities with child

    Singing and reading Total score range 0-70. High score is better.

    Measured: child age 12 months

  11. Being a Mother (BAM-13)

    Maternal confidence. Total score range 0-39. Low score is better

    Measured: child age 3 and 12 months

  12. 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)

    Measured: Baseline, 3 and 12 months

  13. 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)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Investigator, Outcomes assessor
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659721
Sponsor's protocol ID
VIVE 100750-751
Acronym
FACAM
Status last verified
Nov 2024
First submitted
4 Sep 2018
Last updated
13 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study protocol and analysis plan will be available

Publications

  • Pontoppidan M, Nygaard L, Thorsager M, Friis-Hansen M, Davis D, Nohr EA. The FACAM study: protocol for a randomized controlled study of an early interdisciplinary intervention to support women in vulnerable positions through pregnancy and the first 5 years of motherhood. Trials. 2022 Jan 24;23(1):73. doi: 10.1186/s13063-022-06022-4.

    PubMed 35073975

Questions about this trial

What is this clinical trial studying?

A study testing FACAM, Care as Usual and COS-P in people with At-risk Pregnant Women, run by VIVE - The Danish Center for Social Science Research at 2 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maternal sensitivity (time frame: at child age 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03659721, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.

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