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Completed

NCT Number: NCT03659721

The Effects of Family Clinic and Municipality

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.

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Key information

Conditions

At-risk Pregnant Women

Age range

15 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

VIVE - The Danish Centre of Social Science Research, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FACAM

Behavioral

Support person

Care as usual

Behavioral

Usual care

COS-P

Behavioral

Attachment based therapy

Primary outcomes

  1. Maternal sensitivity

    Time frame: at child age 12 months

    Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

Secondary outcomes

  1. Maternal Sensitivity

    Time frame: at child age 3 months

    Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

  2. Coding interactive bahavior (CIB)

    Time frame: child age 3 and 12 months

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

  3. Ages and Stages Questionnaire-Social Emotional 2 (ASQ:SE-2)

    Time frame: 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.

  4. Edinburgh Postnatal depression Scale (EPDS)

    Time frame: child age 3 and 12 months

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

  5. Warwick-Edinburgh Mental Well-being Scale

    Time frame: 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.

  6. Prenatal Parental reflective functioning questionnaire (P-PRFQ)

    Time frame: 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)

  7. Parental reflective functioning questionnaire (PRFQ-1)

    Time frame: 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.

  8. Parental Stress Scale (PSS)

    Time frame: Cild age 3 and 12 months

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

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

    Time frame: child age 3 months

    Child development

  10. Activities with child

    Time frame: child age 12 months

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

  11. Being a Mother (BAM-13)

    Time frame: child age 3 and 12 months

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

  12. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline, 3 and 12 months

    Two subscales Anxiety (range 0-21 low score is better) and depression (range 0-21 low score is better)

  13. Experiences in Close Relationship Scale-Short Form (ECR-S)

    Time frame: Baseline

    Two subscales Anxiety (range 1-42 low score is better) and Avoidance (range 1-42 low score is better)

Sponsors and collaborators

Lead sponsor

VIVE - The Danish Center for Social Science Research

Other

Collaborators

  • Odense Kommune
  • Odense Patient Data Explorative Network
  • Odense University Hospital
  • Syddansk Universitet

Registry information

Official study title

The Effects of Family Clinic and Municipality (FACAM)

Acronym: FACAM

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2018
Registry last updated
Nov 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.