Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Children growing up in disadvantaged areas face more difficulties in life than children in other areas. In Rinkeby, a disadvantaged area in Stockholm, 95% of the population has an immigrant background, a large proportion is at risk of poverty and the unemployment rate is almost 50%. The proportion of children reported to social services because of difficulties in the family is four times higher than the county average. It is possible that parents living in disadvantaged areas require more support in order to ensure the healthy development of their child. In this study, a new support program in which parents receive six home visits from a child health nurse is examined in order to find out if it can improve care and child development compared to standard practice.

Who can participate?
All first-time parents registering at Rinkeby Child Health Centre, Husby Child Health Centre, Akalla Child Health Centre, and Hässelby-Vällingby Child Health Centre who are willing to participate.

What does the study involve?
All first time parents registering their new-born at Rinkeby Child Health Centre are offered six home visits from a child health nurse when their child is aged between 2-15 months. At these visits, they are offered education and support to help strengthen them in their role as a parent. The sessions are adapted depending on what stage of development the child is at, and each sessions lasts for between one and one-and-a-half hours. First time parents registering at neighboring clinics receive standard care, which involves a single visit from a child health nurse when their child is two months old. Participants in both groups are interviewed when the child is two and 15 months old in order to find out what they think of the health care they have received. Medical records of children from both groups are also compared at a range of timepoints until the child is three years old to compare development.

What are the possible benefits and risks of participating?
Participants who take part in the support program benefit from receiving information and guidance on issues related to raising a small child, tailor-made to their needs, and more information regarding available services in Swedish society. Participants may also benefit from gaining more trust in the Swedish health care system and form a closer relationship to the staff visiting them. A potential risk is that some participants may be stigmatized (negatively marked) for receiving this “extra” service, which is why Child Health Centres are not allocated to receiving the program at random.

Where is the study run from?
Participants are recruited from Rinkeby Child Health Centre, Husby Child Health Centre, Akalla Child Health Centre, and Hässelby-Vällingby Child Health Centre and the study takes place in participant homes (Sweden)

When is the study starting and how long is it expected to run for?
August 2012 to December 2017

Who is funding the study?
1. Public Health Agency of Sweden (Sweden)
2. Stockholm County Council (Sweden)

Who is the main contact?
Professor Bo Burström

Trial website

Contact information



Primary contact

Prof Bo Burström


Contact details

Karolinska Institutet
Department of Public Health Sciences
Equity and Health Policy Research group
SE 17177
+46 (0)8 524 801 60

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Extended postnatal home visiting to first-time parents in a disadvantaged area in Stockholm


Study hypothesis

Extended home visiting to first-time parents will strengthen parents in disadvantaged areas in their new role, which will improve health of parents and children

Ethics approval

Regional Ethical Review Board, Stockholm, 12/06/2013, ref: 2013/877-31/1

Study design

Non randomised study

Primary study design


Secondary study design

Non randomised study

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Optimising child health services in collaboration with social services


All new parents registering at Rinkeby Child Health Centre who consent to participate in the study receive six home visits by a child health nurse and a parental advisor when the child is aged 2-15 months. Within these visits, different themes are discussed:
1. Welcoming your child
2. Getting to know your child
3. Being together
4. To show the world
5. To lead and follow
6. Being a family
Sessions are adapted to phases of the development of the child and also include advice on how to relate to the child, emotional and physical contact, feeding, sleep, guiding the child, child safety, informing about child day care and other services. Parents are invited to ask questions and the home environment for the child is discussed. Each session lasts for approximately 1-1.5 hours.

Parents registered at neighbouring health centres act as a comparator, and receive standard care which involves receiving a single visit by a child health nurse when the child is aged about 2 months.

Participants in both groups continue to attend regular scheduled visits to the clinic.

The parents of the children followed (in the intervention and control areas) are interviewed twice – when the child is aged 2 months and 15 (to 18) months, using a questionnaire about parental health and satisfaction with care.

Another source of information is the electronic child health record, where visits to the child health clinic but also to other health care establishments (clinics, emergency ward, hospital) are recorded, as well as vaccinations, growth, development and language (deviations). The child health programme follows a regular schedule of planned doctor visits, where these issues are registered (at 3, 6, 12, 18 months and 3 years of age).

A third source of data is administrative records including all children within the intervention and control areas, where participants cannot be distinguished from non-participants, for looking at emergency ward visits and hospitalisations. Time trends are analysed to see whether the development in intervention areas differ from control areas, and whether any change coincides in time with the intervention.

Intervention type



Drug names

Primary outcome measure

1. Parental health and satisfaction with care are measured using a questionnaire (with a question on self-rated health, and a question on satisfaction with care) at child’s age 2 months and 15 months
2. Child health and growth is measured using height and weight at doctor visits at age 3, 6, 12 and 18 months.
3. Language abilities of child are measured at age 3 years, using a Swedish child health screening instrument
4. Health care utilisation is measured using review of medical records at doctor visits at age 3, 6, 12 and 18 months
5. Dental caries in children are measured using dental examination at age 3 years
6. Child care attendance is measured by question at interview at 15 months of age

Secondary outcome measures

1. Vaccination coverage is measured by having completed all vaccinations at 2 years of age, from child health record
4. Emergency ward visits among children are measured by analysis of time series (2013, 2014, 2015 and 2016) of administrative data for children aged 0-1 and 1-2 years residing in intervention and control areas, respectively
5. Proportion of children with developmental deviations are measured at age 3 years, using a Swedish child health screening instrument at doctor visit

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

All first-time parents registering at Rinkeby Child Health Centre (intervention centre), Husby Child Health Centre (control centre), Akalla Child Health Centre (control centre), and Hässelby-Vällingby Child Health Centre (control centre) who are willing to participate.

Participant type


Age group




Target number of participants

Aim was to have parents of 70+ first-born children

Total final enrolment


Participant exclusion criteria

No exclusion criteria used

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Rinkeby Child Health Centre (intervention centre)
3, Rinkebysvängen 70D Spånga
SE 16372

Trial participating centre

Husby child health centre (control centre)
Edvard Griegsgången 12

Trial participating centre

Akalla child health centre (control centre)
Sibeliusgången 20A

Trial participating centre

Hässelby-Vällingby child health centre (control centre)
Hässelby torg 20

Sponsor information


Karolinska Institutet

Sponsor details

Tomtebodavägen 18A
SE 17177

Sponsor type




Funder type


Funder name

Public Health Agency of Sweden

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Stockholms Läns Landsting

Alternative name(s)

Stockholm County Council

Funding Body Type

government organisation

Funding Body Subtype

Local government



Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

Intention to publish date


Participant level data

Not expected to be available

Basic results (scientific)

Publication list

2017 protocol in:
2018 results in: (added 11/06/2019)
2019 results in: (added 11/06/2019)

Publication citations

Additional files

Editorial Notes

11/06/2019: The following changes were made to the trial record: 1. Publication references added. 2. The total final enrolment was added. 30/01/2017: Publication reference added.