The effectiveness of Nurse Family Partnership intervention.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR854
• Date of registration: 19/12/2006
• Primary sponsor: VU University Medical Center, EMGO-Institute
• Public title: The effectiveness of Nurse Family Partnership intervention.
• Scientific title: Nurse 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. - Nurse Family Partnership
• Date of first enrolment: 1/1/2007
• Target sample size: 456
• Recruitment status: recruiting
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=854
• Study type: intervention
• Study design: Randomised: Yes; Masking: Single; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: Mieke Haan de

• Name: Frank Leerdam van

Key inclusion & exclusion criteria

Inclusion criteria: 1. 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 criteria: 1. Heavy psychiatric problems or obvious psychosis;
2. Heavy drugs- or alcohol-addiction.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Pregnancy, At-risk mothers-to-be

Intervention(s)

The 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 Outcome(s)

At 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 Outcome(s)

1. Preconditions necessary for an optimal implementation;
2. Cost-effectiveness of the intervention.

Secondary ID(s)

ISRCTN16131117

N/A

Source(s) of Monetary Support

ZON-MW, The Netherlands Organization for Health Research and Development

Secondary Sponsor(s)

VU University Medical Center, Department of Public and Occupational Health