Scaling up a post-natal extended home visiting program for a good start in life in disadvantaged areas in Gothenburg, Sweden
| ISRCTN | ISRCTN19253469 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN19253469 |
- Submission date
- 16/08/2024
- Registration date
- 12/09/2024
- Last edited
- 12/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
A Swedish-developed infant home visiting program, created and evaluated in Rinkeby, a marginalized district in the city of Stockholm has the promise of contributing to the attainment of sustainable development goals. To attain positive outcomes with home visiting programs, careful attention to the implementation process is needed. This study seeks to describe the scale-up of the program in a new context from a variety of perspectives and measure outcomes and effects of the program both short and long-term. The study also seeks to highlight the collaborative role of social services. The evaluation is based on qualitative and quantitative methods from interviews, focus groups, questionnaires, journal data and documentation. In the foundation research, two studies explore the perspective of professionals, and two studies explore parents' perspectives. An indicator study explores the potential health-related effects of the program during the child's first 18 months of life, and a pilot study followed up with children at 30 months of age. Two additional implementation studies explore the experience of facilitators, barriers, and solutions in the pre-implementation phase of the scale-up, and program fidelity by analyzing data submitted by professionals following each home visit.
Who can participate?
All first-time parents, or parents having their first child in Sweden aged between 20 and 50 years old, registered to receive the ordinary universal child health care services in the following child health centers are eligible for the study: Västra Frölunda Närhälsan Opaltorget, Angered Centrum Närhälsan, Angered Centrum Capio, Angered Gårdsten, Angered Lövgärdet, Friskväderstorget Närhälsan, Biskopsgården Nötkärnan.
What does the study involve?
All first-time parents registering their newborn in one of the seven participating child health centers (above) are offered six home visits from a child health nurse and social worker from preventive social services between the child's birth and 15 months of age. 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 session lasts for between one and one-and-a-half hours. Participants complete questionnaires when the child is two months and 15 months, and a purposeful sample of parents will also be interviewed after the program to find out what they think of the health care they have received. Medical records of children from participating families are compared to aggregated health data at 18 months and compared with a subset of nonparticipating families from control child health centers at 30 months to compare health indicators and development.
Documentation from the pre-implementation planning period as well as provider ratings of program fidelity following each home visit will be analyzed to study the implementation process and quality. Staff delivering the program will be interviewed about their experiences and the significance of the program.
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 healthcare system and forming a closer relationship with the staff visiting them. A potential risk is that some participants may be stigmatized (negatively marked) for receiving this “extra” service.
Where is the study run from?
The study is run from the participating CHCs listed above, and the intervention takes place in the families' homes.
When is the study starting and how long is it expected to run for?
The study period is from October 2018 to June 2022
Who is funding the study?
The research was jointly funded by Region Västra Götaland and The City of Gothenburg
Who is the main contact?
Julie Lundgren, julie.lundgren@vgregion.se
Contact information
Public, Scientific
Kungsgatan 12, 6th floor
Göteborg
41119
Sweden
 ORCID ID |
0000-0002-3167-3190 |
|---|---|
| Phone | +46 0736974096 |
| julie.lundgren@vgregion.se |
Principal Investigator
Göteborgsregionen
Research and Development in the West
Box 5073
Gothenburg
402 22
Sweden
| ORCID ID |
0000-0003-4321-5434 |
|---|---|
| Phone | +46 (0)31-3355000 |
| lisbeth.lindahl@goteborgsregionen.se |
Study information
| Study design | Non-randomized implementation research study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Medical and other records |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Scaling up a post-natal extended home visiting program for a good start in life in disadvantaged areas in Gothenburg, Sweden |
| Study acronym | HOMEVISITSGBG |
| Study objectives | Extending the number of home visits during the infancy period will improve parents' satisfaction with healthcare and social services, parenting self-efficacy and well-being, as well as short- and long-term child-related health indicators. The program will contribute towards increased health equity in Sweden. The method will be scaled up with fidelity. Providers delivering the method will find it feasible and meaningful to work with. Lessons will be learned from stakeholders responsible for securing good conditions for the implementation about facilitators and barriers in the scale up process. |
| Ethics approval(s) |
Approved 18/06/2019, Regional Ethical Review Board, Gothenburg (Box 2110, Uppsala, 750 02, Sweden; +46 010-475 08 00; registrator@etikprovning.se), ref: Dnr 2019-03392, Dnr 2020-02077, Dnr 2021-06548- 02 |
| Health condition(s) or problem(s) studied | Scaling up an evidence-based early childhood parent support model for better health equity |
| Intervention | Rinkeby extended home visiting program: All new parents registering at participating Child Health Centers in seven prioritized areas of Gothenburg will be offered the intervention and asked to consent to participate in the study. The program entails six home visits by a child health nurse and a parent support social worker from birth to 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, and informing about child daycare 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. |
| Intervention type | Behavioural |
| Primary outcome measure | The primary measures of effects on child health indicators are measured by comparing child health journal data with aggregated child health statistics at 18 months, and comparison of program participants with non-participant controls at 30 months (pilot study). |
| Secondary outcome measures | 1. Parents' perspectives are measured using self-reported satisfaction with the program, health, and parenting self-efficacy before and after program participation, as well as via interviews. Provider perspectives are evaluated using interviews. 2. Fidelity is measured with a mixed methods analysis of questionnaire data submitted by professionals after each visit. Implementation quality is measured by an analysis of documentation. Pre-implementation facilitators and barriers are measured with mixed methods. |
| Overall study start date | 01/10/2018 |
| Completion date | 30/06/2022 |
Eligibility
| Participant type(s) | Health professional, Service user |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 317 |
| Key inclusion criteria | First-time parents and parents having their first child in Sweden in seven prioritized geographic areas characterized by socioeconomic disadvantage |
| Key exclusion criteria | There are no participant exclusion criteria. |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 28/02/2022 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Västra Frölunda
42164
Sweden
Angered
424 65
Sweden
Angered
424 65
Sweden
Angered
42441
Sweden
Angered
424 45
Sweden
Göteborg
418 38
Sweden
Göteborg
418 33
Sweden
Sponsor information
Government
Center for Progress in Children's Mental Health, Kungsgatan 12, 6th floor
Göteborg
41119
Sweden
Government
Anders Personsgatan 8 i Gårda
Göteborg
40222
Sweden
| Phone | +46313650000 |
|---|---|
| gr@goteborgsregionen.se | |
| Website | https://goteborgsregionen.se/kunskapsbank/fouivast.5.76b3d79b17bcd4916ae44513.html |
Government
Gustaf Adolfs Torg 4A
Göteborg
41110
Sweden
| Phone | +46 031-365 00 00 |
|---|---|
| stadsledningskontoret@stadshuset.goteborg.se | |
| Website | https://goteborg.se/wps/portal/enhetssida/jamlikt-goteborg |
Funders
Funder type
Government
No information available
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Main results have been disseminated in a local report. One article has been published in a peer-reviewed journal. One article is expected to be submitted to a peer-reviewed journal in August, 2024 |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Julie Lundgren, julie.lundgren@vgregion.se. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Funder report results | in Swedish | 01/04/2022 | 16/08/2024 | No | No |
| Funder report results | in Swedish | 30/08/2023 | 16/08/2024 | No | No |
| Results article | 18/03/2024 | 16/08/2024 | Yes | No |
Additional files
- 45953_FunderReport_01April2022.pdf
- in Swedish
- 45953_FunderReport.pdf
- in Swedish
Editorial Notes
16/08/2024: Study's existence confirmed by Regional Ethical Review Board, Gothenburg.
