Contact information
Type
Scientific
Contact name
Ms Mieke de Haan
ORCID ID
Contact details
EMGO instituut
Afd. Sociale Geneeskunde
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8108
mi.dehaan@vumc.nl
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The effectiveness of Nurse Family Partnership intervention
Acronym
Nurse Family Partnership
Study hypothesis
Compared to children receiving usual care, children receiving the Nurse Family Partnership (NFP)-intervention will have better birth outcome, growth and development, psycho-social outcomes and behavioural outcomes in the first years of life, and also later in life.
Ethics approval(s)
Ethics approval received from the local medical ethics committee
Study design
Randomised, active controlled, parallel group, single blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pregnancy in at-risk mothers-to-be
Intervention
Intervention group:
The Nurse Family Partnership intervention consists 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 and will last until the child is two years of age. The frequency is about two visits each month with a higher frequency (once a week) in the first month of the programme and the first six weeks after birth, with a declining frequency (once a month) in the last four months. Every home visit lasts one to 1.5 hours.
Control group:
Care as usual.
Intervention type
Other
Primary outcome measure
1. At the start of the study women will be interviewed about the following conditions:
a. physical: diseases, diet, cigarette smoking, drug abuse, etc.
b. emotional: feelings of anxiety and depression, a history of abuse or neglect
c. relational: partner, social support
d. social determinants: education, financial problems, housing, use of current health care
The mothers' sense of control about her circumstances is determined. Partners are being asked to report emotional or behavioural problems. A urine sample will be taken to determine urinary infections
2. During the entire study measurements of the following will be used in the study:
a. height and weight
b. breast- or bottle-feeding
c. development according to Van Wiechen classification scheme
These will be 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.
3. At the age of six months, we measure development, anxiety and mother-child interactions.
4. At the ages of one and two years the home situation will be observed according to:
a. safety
b. availability of food and fruit and of toys
5. At the age of two other determinants are:
a. child abuse
b. finance
c. home
d. education
e. anti-conception
f. pregnancies
g. stability relation with the father
h. psychopathology of the mother
Secondary outcome measures
1. Pre-conditions necessary for an optimal implementation
2. Cost-effectiveness of the intervention
Overall study start date
01/01/2007
Overall study end date
01/07/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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 secondary inclusion criteria:
a. no (supportive) social network or partner
b. alcohol or drug abuse
c. actual violence in family or partner
d. history of abuse
e. psychological problems such as anxiety or depression
f. non-realistic approach about motherhood
g. drop-out of school
h. unemployed
i. financial or housing-problems
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
456
Participant exclusion criteria
1. Heavy psychiatric problems or obvious psychosis
2. Heavy drugs or alcohol addiction
Recruitment start date
01/01/2007
Recruitment end date
01/07/2009
Locations
Countries of recruitment
Netherlands
Study participating centre
EMGO instituut
Amsterdam
1081 BT
Netherlands
Sponsor information
Organisation
VU University Medical Centre (The Netherlands)
Sponsor details
Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Research organisation
Funder name
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
Not provided at time of registration
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 21/10/2011 | Yes | No |