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van CCT (UK)

van CCT (UK)

The effectiveness of Nurse Family Partnership intervention.

- candidate number2375
- NTR NumberNTR854
- Date ISRCTN created11-apr-2007
- date ISRCTN requested24-mrt-2007
- Date Registered NTR19-dec-2006
- Secondary IDsN/A 
- Public TitleThe effectiveness of Nurse Family Partnership intervention.
- Scientific TitleNurse Family Partnership - development and implementation of a preventive intervention targeting the physical, emotional and cognitive development of yet-to-be born infants and their mothers in high risk populations.
- ACRONYMNurse Family Partnership
- hypothesisCompared to children receiving usual care, children receiving the NFP-intervention will have better birth outcome, growth and development, psycho-social outcomes and behavioral outcomes in the first years of life, and also later in life.
- Healt Condition(s) or Problem(s) studiedPregnancy, At-risk mothers-to-be
- Inclusion criteria1. No previous born child (a number of pregnant women did have an abortion); 2. Pregnancy duration of maximum 28 weeks; 3. Low education grade; 4. Some knowledge of the Dutch language; 5. Furthermore, one or more of the following secundary inclusion criteria: no (supportive) social network or partner, alcohol - or drugabuse, actual violence in family or partner, history of abuse, psychologic problems such as anxiety or depression, non-realistic approach about motherhood, drop-out of school, unemployed, financial or housing-problems.
- Exclusion criteria1. Heavy psychiatric problems or obvious psychosis; 2. Heavy drugs- or alcohol-addiction.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-jul-2009
- Target number of participants456
- InterventionsThe Nurse Family Partnership intervention exists of an intensive schedule of approximately 30 home visits (maximal 60) by experienced youth health nurses. The home visits will start from the 16th week of pregnancy en will last until the child is 2 years of age. The frequency is about 2 visits each month with a higher frequency (once a week) in the first month of the programme and the first 6 weeks after birth, with a declining frequency (once a month) in the last 4 months. Every home visit lasts 1 to 1.5 hours. Control: care as usual.
- Primary outcomeAt the start of the study women will be interviewd about their physical condition (diseases, diet, sigarette smoking, drug abuse, etc.), emotional (feelings of anxiety and depression, a history of abuse or neglect), relational (partner, social support), and social determinants (education, financiel problems, housing, use of current health care). Mothers' sense of control about her circumstances is determined. Partners are being asked to report emotional or behavioral problems. A urine sample will be taken to determine urinary infections. During the entire study measurements of height and weight, breast- or bottle feeding, and development according to Van Wiechen, collected by the regular health system will be used in the study. Also, data of the delivery and first week after birth will be collected from the files of primary health care. At the age of 6 months, we measure development, anxiety and mother-child interactions. At the ages of 1 and 2 years the home situation will be observed according to safety, availability of food and fruit and of toys. At the age of 2 other determinants are: child abuse, finance, home, education, anti conception, pregnancies, stability relation with the father, psychopathology of the mother.
- Secondary outcome1. Preconditions necessary for an optimal implementation; 2. Cost-effectiveness of the intervention.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- Sponsor/Initiator VU University Medical Center, Department of Public and Occupational Health, VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryImplementation and research of the Nurse Family Partnership intervention, in which risk factors threathening the physical, the cognitive and the behavioral development during pregnancy and in the first 2 years of life are being reduced in yet-to-be-born children of high-risk mothers. The ultimate goal is to improve pregnancy and birth outcomes for mother and child, to improve personal development and the opportunities for education and work for the mothers in order to make her more available for her child. The study design is besed on a trial with 456 selected pregnant hig-risk mother randomly divided into a control and an intervention group. The high-risk pregnant women will be visited regularly by nurses during pregnancy, after the child is born, and 6 months, 1 year and 2 years after birth. During these visits the nurses will systematically adress (1) changes in mothers' behavior to promote the infants' health and development and to improve mothers'living circumstances with an emphasis on the improvement of diet and physical health and the reduction of substance use during pregnancy, (2) the quality of supportive relationship, and (3) the link between the mother and the regular services.
- Main changes (audit trail)
- RECORD19-dec-2006 - 12-apr-2007

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