The effectiveness of Nurse Family Partnership intervention

ISRCTN	ISRCTN16131117
DOI	https://doi.org/10.1186/ISRCTN16131117
Secondary identifying numbers	N/A

Submission date: 11/04/2007
Registration date: 11/04/2007
Last edited: 14/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Mieke de Haan
Scientific

EMGO instituut
Afd. Sociale Geneeskunde
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8108
Email	mi.dehaan@vumc.nl

Study information

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
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	The effectiveness of Nurse Family Partnership intervention
Study acronym	Nurse Family Partnership
Study objectives	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
Health condition(s) or problem(s) studied	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
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	456
Key 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
Key exclusion criteria	1. Heavy psychiatric problems or obvious psychosis 2. Heavy drugs or alcohol addiction
Date of first enrolment	01/01/2007
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

EMGO instituut

Amsterdam
1081 BT
Netherlands

Sponsor information

VU University Medical Centre (The Netherlands)
Hospital/treatment centre

Department of Public Health
P.O. Box 7057
Amsterdam
1007 MB
Netherlands

Website	http://www.vumc.nl/english/
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	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

Editorial Notes

14/11/2022: Internal review.
04/01/2021: Publication status added.