The Effects of Family Clinic and Municipality (FACAM)

• ClinicalTrials.gov Identifier: NCT03659721
• Recruitment Status: Active, not recruiting
• First Posted: September 6, 2018
• Last Update Posted: January 25, 2022
• Sponsor: VIVE - The Danish Center for Social Science Research
• Collaborators: Odense University Hospital; Syddansk Universitet; Odense Patient Data Explorative Network; Odense Kommune
• Information provided by (Responsible Party): VIVE - The Danish Center for Social Science Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
At-risk Pregnant Women	Behavioral: FACAM; Behavioral: Care as Usual; Behavioral: COS-P	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 332 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Investigator, Outcomes Assessor)
• Masking Description: As the participants are offered extra support as the intervention neither participants nor care providers can be blinded. Outcome assessor and data analyst will be blinded.
• Primary Purpose: Prevention
• Official Title: The Effects of Family Clinic and Municipality (FACAM)
• Actual Study Start Date: October 1, 2018
• Estimated Primary Completion Date: March 31, 2023
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: FACAM; 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; Support person; Behavioral: COS-P; Attachment based therapy
Active Comparator: Care as Usual; 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; Usual care

Outcome Measures

Primary Outcome Measures :

1. Maternal sensitivity [ Time Frame: at child age 12 months ]
   Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

Secondary Outcome Measures :

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)

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Participants must be pregnant women
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Denmark

VIVE - The Danish Centre of Applied Social Science

Copenhagen, Denmark, 1052

Odense University Hospital

Odense, Denmark, 5000

Sponsors and Collaborators

VIVE - The Danish Center for Social Science Research

Odense University Hospital

Syddansk Universitet

Odense Patient Data Explorative Network

Odense Kommune

Investigators

• Principal Investigator: Maiken Pontoppidan, PhD; VIVE

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: VIVE - The Danish Center for Social Science Research
• ClinicalTrials.gov Identifier: NCT03659721
• Other Study ID Numbers: VIVE 100750-751
• First Posted: September 6, 2018
• Last Update Posted: January 25, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: Study protocol and analysis plan will be available

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VIVE - The Danish Center for Social Science Research:

Pregnant; Infant; Parent; Family; Mother; Support