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Register:	ISRCTN
Last refreshed on:	28 November 2022
Main ID:	ISRCTN16131117
Date of registration:	11/04/2007
Prospective Registration:	No
Primary sponsor:	VU University Medical Centre (The Netherlands)
Public title:	The effectiveness of Nurse Family Partnership intervention
Scientific title:	The effectiveness of Nurse Family Partnership intervention
Date of first enrolment:	01/01/2007
Target sample size:	456
Recruitment status:	Completed
URL:	https://www.isrctn.com/ISRCTN16131117
Study type:	Interventional
Study design:	Randomised, active controlled, parallel group, single blinded trial (Quality of life)
Phase:	Not Specified

Countries of recruitment
Netherlands

Contacts

Name:	Mieke de Haan
Address:	EMGO instituut Afd. Sociale Geneeskunde Van der Boechorststraat 7 1081 BT Amsterdam Netherlands
Telephone:	+31 (0)20 444 8108
Email:	mi.dehaan@vumc.nl
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

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 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

Exclusion criteria:
1. Heavy psychiatric problems or obvious psychosis
2. Heavy drugs or alcohol addiction

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Pregnancy in at-risk mothers-to-be
Pregnancy and Childbirth
Pregnancy

Intervention(s)

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.

Primary Outcome(s)

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(s)

1. Pre-conditions necessary for an optimal implementation
2. Cost-effectiveness of the intervention

Secondary ID(s)

N/A

Source(s) of Monetary Support

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Ethics approval received from the local medical ethics committee

Results

Results available:	Yes
Date Posted:
Date Completed:	01/07/2009
URL:

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