Evaluation of 'Mothers of Rotterdam' program: Care for highly vulnerable pregnant women in the home environment|
|- candidate number||26861|
|- NTR Number||NTR6271|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mrt-2017|
|- Secondary IDs||MEC-2016-012 Research Ethics Committee of the Erasmus Medical |
|- Public Title||Evaluation of 'Mothers of Rotterdam' program: Care for highly vulnerable pregnant women in the home environment|
|- Scientific Title||Evaluation of 'Mothers of Rotterdam' program: Care for highly vulnerable pregnant women in the home environment|
|- hypothesis||By providing more intensive social care to highly vulnerable pregnant women, the mother will be more self-sufficient, experiences less stress and the child will develop better, compared to highly vulnerable pregnant women receiving normal social care.|
|- Healt Condition(s) or Problem(s) studied||Pregnancy, Vulnerabilities, Development|
|- Inclusion criteria||- pregnant women|
- residing in the municipality of Rotterdam
- highly vulnerable as determined during a home visit
|- Exclusion criteria||Women who do not provide written consent and/or are not sufficiently skilled at understanding one of the provided languages are excluded from the study. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||4-jan-2016|
|- planned closingdate||31-dec-2019|
|- Target number of participants||1122|
|- Interventions||Specific Social Care (SSC) is a newly developed program, which aims to provide care to the mother (to be) during pregnancy, and will last up to the second birthday of the child. ). In general, the program is divided into three main phases: 1) resolving the acute crisis situation, by taking over control; 2) creating ideal circumstances for a safe mother-child attachment, by working together with the mother; and 3) developing parenting skills in the mother, while paying attention to the child’s development, and stimulating the mother to actively participate in society, by letting mother act autonomously. SSC not only focusses on the problems in the social domain, but also pays attention to potential problems in the medical domain. The care providers promote a healthy lifestyle as well as regular visits to the obstetric professional during pregnancy, and visits to a general practitioner or specialist when medical complaints exist. Also, they encourage mothers to regularly visit the Preventive Child Health Care (PCHC) centers for the monitoring of health and development of the child. By doing so, the program aims to reduce avoidance of care and promote preventive health behavior. |
The intensity of SSC is high at the start (two home visits a week) and deceases over time (one home visit every two weeks). Care is provided by a team of social service professionals and low-professionals (interns in their last year of study). By using these low-professionals, the costs for this intensive social care program can be reduced, while the professionals keep oversight on the mother, the intern, and the provided care. Furthermore, low-professionals might be perceived as less threatening by the mother, resulting in more trust between mother and care provider.
All-round Social Care (ASC) is the program that was already executed in Rotterdam, which aims to provide social care to all persons with social problems for three to nine months. The methodology of ASC is driven by the request for social support formulated by the client. The care providers are skilled in detecting (potential) problems, while providing basic support and guidance for solving these problems. If necessary, the client is referred to other (social) welfare organizations for additional support. The care of ASC is of average intensity (although tailored to the problems of the client), with approximately one visit every (two) week(s). ASC is delivered by a multidisciplinary team of professionals, allocated in the neighborhood of their clients. With regard to the specific population of highly vulnerable pregnant women, professionals with experience in problems of youth and adults work closely together. All care providers are professionals with an education in social services or behavioral science, with experience in youth or mental health social services.
|- Primary outcome||Mother: a reduction of stress, anxiety, or depression, measured with the Depression, Anxiety, and Stress Scales (DASS)|
Child: the proportion of children with a delay in development measured with the Ages and Stages Questionnaire, at the age of one year.
Provided care: Self-sufficiency of the mother at the end of the social care program, according to the care provider, measured with the Self Sufficiency matrix.
|- Secondary outcome||Mother: pregnancy outcome, motivation for the social care program, and a safe home environment.|
Child: parenting skills, feelings of bonding, and feelings of competence.
Provided care: the number of unexpected escalations; and compliance to the social care program.
|- Timepoints||T0 = baseline|
T1 = 6 weeks after start of social care program if participant is still pregnant
T2 = 6 weeks postpartum
T3 = 6 months postpartum
T4 = 12 months postpartum
T5 = 18 months postpartum
T6 = 24 months postpartum
T7 = end of social care program
T8 = 6 months follow-up after end of social care program
|- Trial web site||www.moedersvanrotterdam.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Marije van der Hulst|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.P. de Graaf|
|- Sponsor/Initiator ||Erasmus Medical Center|
(Source(s) of Monetary or Material Support)
|Stichting de Verre Bergen |
|- Brief summary||In-utero development is the foundation for future development, health and disease. Hardships experienced by the mother (both medical and social), influence the development of the infant. The municipality of Rotterdam (second largest city of the Netherlands) has committed itself to improve the physical and psycho-social situation of highly vulnerable pregnant women, and to improve conditions for a healthy development of the (unborn) child. The “Mothers of Rotterdam” (MoR) study compares a specialized social care (SSC) and an all-round social care (ASC) program regarding their effects on the a) maternal (mental) health; b) infant development; and c) provided care.
The MoR study is a prospective observational cohort study, aiming to include 1122 highly vulnerable pregnant women for the comparison of SSC and ASC. SSC is characterized by long term support (until age 2 of the child) by professionals and low-professionals, with the focus on social care, while stimulating compliance to medical care. ASC is characterized by short-term support (3-9 months), provided by professionals only, with the focus on social care. Data will be collected in mother, child, and care provider(s); regarding maternal health, infant development, and provided care; at nine different time points from pregnancy until the 2nd birthday of their child.
Given that in-utero development is a critical and sensitive period, important opportunities for intervention can also be found during this period. Therefore, the importance of research in the effectiveness of social care programs for this highly vulnerable population cannot be stressed enough.
Recruitment of participants takes place only in Rotterdam, the Netherlands.
|- Main changes (audit trail)|
|- RECORD||10-mrt-2017 - 29-apr-2017|
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