Trials / Completed
CompletedNCT03659721
The Effects of Family Clinic and Municipality
The Effects of Family Clinic and Municipality (FACAM)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 332 (actual)
- Sponsor
- VIVE - The Danish Center for Social Science Research · Academic / Other
- Sex
- Female
- Age
- 15 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | FACAM | Support person |
| BEHAVIORAL | Care as Usual | Usual care |
| BEHAVIORAL | COS-P | Attachment based therapy |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2023-11-30
- Completion
- 2023-11-30
- First posted
- 2018-09-06
- Last updated
- 2024-11-13
Locations
2 sites across 1 country: Denmark
Source: ClinicalTrials.gov record NCT03659721. Inclusion in this directory is not an endorsement.