The Effects of Family Clinic and Municipality

NCT03659721 | Completed

• 1 other identifier: VIVE 100750-751
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 2

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.

Conditions

At-risk Pregnant Women

Keywords

Pregnant; Infant; Parent; Family; Mother; Support

Outcome Measures

Primary Outcomes (1)

• Maternal sensitivity

  Maternal sensitivity measured by the CIB (Coding Interactive Behavior)

  at child age 12 months

Secondary Outcomes (13)

• Maternal Sensitivity

  at child age 3 months

• Coding interactive bahavior (CIB)

  child age 3 and 12 months

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

  child age 3 and 12 months

• Edinburgh Postnatal depression Scale (EPDS)

  child age 3 and 12 months

• Warwick-Edinburgh Mental Well-being Scale

  child age 3 and 12 months

Study Arms (2)

FACAM

EXPERIMENTAL

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; Behavioral: COS-P

Care as Usual

ACTIVE COMPARATOR

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

Interventions

FACAM BEHAVIORAL

Support person

FACAM

Care as Usual BEHAVIORAL

Usual care

Care as Usual

COS-P BEHAVIORAL

Attachment based therapy

FACAM

Eligibility Criteria

• Age: 15 Years+
• Gender Eligibility Details: Participants must be pregnant women
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• VIVE - The Danish Center for Social Science Research: lead
• Odense University Hospital: collaborator
• Syddansk Universitet: collaborator
• Odense Patient Data Explorative Network: collaborator
• Odense Kommune: collaborator

Study Sites (2)

VIVE - The Danish Centre of Social Science Research

Copenhagen, 1052, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 35073975 DERIVED

Study Officials

• Maiken Pontoppidan, PhD

  VIVE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 6, 2018
• Study Start: October 1, 2018
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: November 13, 2024

Record last verified: 2024-11

Locations

DK (2)