Identification of Family ViolenceNCT07158983
Evaluation of a Child Health Care Program for Early Identification of Family Violence
An observational study of Identification of Family Violence, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of this mixed methods study is to gain knowledge about how a program for identification of family violence works within child health services. The main research questions are: To what extent are questions about family violence asked to mothers and fathers visiting the child health services in the Region of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Identification of Family Violence
- What is being tested?
- Registry review and Interviews
- How many people
- 90,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Oct 2025to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The population are parents to children enrolled in CHS in the Stockholm region and nurses working in CHS in the Stockholm region
Who may be able to join
- Parents to children enrolled in the CHS
- Child health nurse working at one of the included CHS centers
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this mixed methods study is to gain knowledge about how a program for identification of family violence works within child health services. The main research questions are:
- To what extent are questions about family violence asked to mothers and fathers visiting the child health services in the Region of Stockholm?
- How can area level socioeconomic factors affect whether parents are asked questions about family violence in the child health services?
- How do child health nurses experience asking parents about family violence?What challenges and opportunities do they meet when they identify family violence?
Read the detailed description
Being exposed to family violence (FV) as a child is associated with an increased risk of negative impact on development and health both in the short and long term. Research shows that FV occurs in all cultures and in all social classes. However, there is an increased risk of FV in areas with a higher degree of social vulnerability. For children, FV means being directly exposed to psychological, physical, sexual violence or neglect. It can also mean experiencing violence between adults in the home, which leads to the same negative consequences for the child. Parents with current or previous experiences with FV have an increased risk of difficulties in parenting skills, which in turn can affect the child negatively.
In Sweden, almost all children 0-5 years old are enrolled in the child health services (CHS). As part of the CHS-program, all parents are offered an individual visit within the first six months of their child's life to address parenting topics and parental mental health. Questions about FV are asked during that individual visit. The CHS thus has a unique opportunity to detect FV in the family at an early stage in the child's life.
This mixed methods study evaluates how a program for identification of family violence works within child health services. The quantitative part is a registry based observational study to investigate the extent to which both mothers and fathers are given the opportunity to respond to questions about FV within CHS in the Stockholm region. Furthermore, it examines whether there is an association between being asked about exposure to violence and the socioeconomic status of the catchment areas of CHS centers. The qualitative data consist of interviews with child health nurses.
De-identified medical record data regarding questions about family violence addressed to the child's parents will be collected from approximately 90,000 child records at the CHS centers. Included CHS centers are located in areas with different socioeconomic status. Data cover the period 240630-250630. Background data on the organizational conditions (number of employees, training to identify FV) of the included CHS centers are also obtained. The results are also measured based on the clinic's sociodemographic, according to the Care Need Index (CNI). The data enables comparisons between different CHS centers, and the interviews contributes to an in-depth analysis of the study's results based on varying contextual factors that may assist or hinder the identification of FV.
- Conditions
- Identification of Family Violence
- Being tested
- Registry review, Interviews
- Keywords
- Family violence, Parental support, Identification, Screening, Primary health care, Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registry reviewOther
The study is set within a project to evaluate a program for identification of family violence. The study uses mixed methods including registry review of parents to evaluate the effect of the program.
InterviewsOther
The study is set within a project to evaluate a program for identification of family violence. The study uses mixed methods including interviews with nurses to evaluate the effect of the program.
| Study group | Role | What they receive |
|---|---|---|
| Parents | Parents of children enrolled in child health services Receives: Other: Registry review | |
| Nurses | Nurses working within child health services Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parents being asked about family violence according to patient records
Mothers and fathers who have been asked about family violence at the child health services according to the child's patient record (yes/no)
Measured: 1 year
Nurses experiences of opportunities and challenges in the work around family violence identified through qualitative assessments
Nurses are asked about opportunities and challenges to pose questions about family violence. They are invited to share their experiences about identifying family violence and offering support.
Measured: Time since the program was implemented, between three and five years
Secondary outcomes (2)
Identification of family violence documented in patient records
Identification of family violence among parents and children enrolled at the CHS (yes/no)
Measured: 1 year
Reports to the social services documented in patient records
Reports to the social services filed by nurses due to identified family violence documented in patient records
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Oct 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Identification of Family ViolenceStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 90,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Forte: Swedish research council for health, working life and welfare
- Responsible party
- Principal investigator, Lene Lindberg, Karolinska Institutet
- Investigators
- Lene Lindberg, Professor, Principal investigator, Karolinska Institutet: Department of Global Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158983
- Sponsor's protocol ID
- FRIDa
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2025
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IDP are not avialable due to the ethical approval. Access to data requires ethical approval and could then be provided upon request.
Publications
Frojlinger A, Blom L, Tiitinen Mekhail K, Lalouni M, Lindberg L. Response to family violence in child health services (FRIDa): study protocol of a mixed-method study in the Stockholm region, Sweden. BMJ Open. 2026 Jul 22;16(7):e115537. doi: 10.1136/bmjopen-2025-115537.
PubMed 42486528
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Child Health Care Program for Early Identification of Family Violence
- ClinicalTrials.gov ID
- NCT07158983
- Acronym / sponsor ID
- FRIDa
- Conditions
- Identification of Family Violence
- Keywords
- Family violence, Parental support, Identification, Screening, Primary health care, Evaluation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 90,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Forte: Swedish research council for health, working life and welfare
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this mixed methods study is to gain knowledge about how a program for identification of family violence works within child health services. The main research questions are:
- To what extent are questions about family violence asked to mothers and fathers visiting the child health services in the Region of Stockholm?
- How can area level socioeconomic factors affect whether parents are asked questions about family violence in the child health services?
- How do child health nurses experience asking parents about family violence?What challenges and opportunities do they meet when they identify family violence?
Detailed description
Being exposed to family violence (FV) as a child is associated with an increased risk of negative impact on development and health both in the short and long term. Research shows that FV occurs in all cultures and in all social classes. However, there is an increased risk of FV in areas with a higher degree of social vulnerability. For children, FV means being directly exposed to psychological, physical, sexual violence or neglect. It can also mean experiencing violence between adults in the home, which leads to the same negative consequences for the child. Parents with current or previous experiences with FV have an increased risk of difficulties in parenting skills, which in turn can affect the child negatively.
In Sweden, almost all children 0-5 years old are enrolled in the child health services (CHS). As part of the CHS-program, all parents are offered an individual visit within the first six months of their child's life to address parenting topics and parental mental health. Questions about FV are asked during that individual visit. The CHS thus has a unique opportunity to detect FV in the family at an early stage in the child's life.
This mixed methods study evaluates how a program for identification of family violence works within child health services. The quantitative part is a registry based observational study to investigate the extent to which both mothers and fathers are given the opportunity to respond to questions about FV within CHS in the Stockholm region. Furthermore, it examines whether there is an association between being asked about exposure to violence and the socioeconomic status of the catchment areas of CHS centers. The qualitative data consist of interviews with child health nurses.
De-identified medical record data regarding questions about family violence addressed to the child's parents will be collected from approximately 90,000 child records at the CHS centers. Included CHS centers are located in areas with different socioeconomic status. Data cover the period 240630-250630. Background data on the organizational conditions (number of employees, training to identify FV) of the included CHS centers are also obtained. The results are also measured based on the clinic's sociodemographic, according to the Care Need Index (CNI). The data enables comparisons between different CHS centers, and the interviews contributes to an in-depth analysis of the study's results based on varying contextual factors that may assist or hinder the identification of FV.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parents | – | Other: Registry reviewParents of children enrolled in child health services |
| Nurses | – | Other: InterviewsNurses working within child health services |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The population are parents to children enrolled in CHS in the Stockholm region and nurses working in CHS in the Stockholm region
Key inclusion criteria (2 listed)
- Parents to children enrolled in the CHS
- Child health nurse working at one of the included CHS centers
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registry reviewThe study is set within a project to evaluate a program for identification of family violence. The study uses mixed methods including registry review of parents to evaluate the effect of the program. | Other | Parents |
| InterviewsThe study is set within a project to evaluate a program for identification of family violence. The study uses mixed methods including interviews with nurses to evaluate the effect of the program. | Other | Nurses |
Primary outcome
Parents being asked about family violence according to patient records
Time frame: 1 year
Mothers and fathers who have been asked about family violence at the child health services according to the child's patient record (yes/no)
Nurses experiences of opportunities and challenges in the work around family violence identified through qualitative assessments
Time frame: Time since the program was implemented, between three and five years
Nurses are asked about opportunities and challenges to pose questions about family violence. They are invited to share their experiences about identifying family violence and offering support.
2 secondary outcomes
Identification of family violence documented in patient records
Time frame: 1 year
Reports to the social services documented in patient records
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Derived from this study: PubMed 42486528Frojlinger A, Blom L, Tiitinen Mekhail K, Lalouni M, Lindberg L. Response to family violence in child health services (FRIDa): study protocol of a mixed-method study in the Stockholm region, Sweden. BMJ Open. 2026 Jul 22;16(7):e115537. doi: 10.1136/bmjopen-2025-115537.
- Individual participant dataSharing planned: No. IDP are not avialable due to the ethical approval. Access to data requires ethical approval and could then be provided upon request.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene Lindberg, Professor principal investigator
Karolinska Institutet: Department of Global Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Identification of Family Violence, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parents being asked about family violence according to patient records (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07158983, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.