Family ViolenceNCT06299501
How Can Child Health Services Identify and Respond to Family Violence
A study testing Routine questions, Questions on evidence based indication and Treatment as usual in people with Family Violence and Domestic Violence, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Family Violence, Domestic Violence, Intimate-partner Violence
- What is being tested?
- Routine questions, Questions on evidence based indication and Treatment as usual
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteSweden
- Study dates
- 23 Aug 2017to 31 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Registered nurse
- Working in any of the Child Health Services in the Stockholm Region
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Can Child Health Services Identify and Respond to Family Violence - a Randomized Controlled Trial to Assess the Effectiveness of Routine Questions or Questions Posed on Indication Compared to Treatment as Usual
Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence.
Read the detailed description
Family violence has severe impacts on children's health and development. Early identification of family violence is imperative to facilitate timely interventions. In Sweden, the Child Health Services (CHS) has a main aim to promote children's health and development and prevent ill health. The Swedish CHS program reaches almost 100% of families and includes 18 scheduled visits characterized by a health-promoting approach focusing on the child and the parents' wellbeing. The CHS offers a unique setting to identify family violence among families with young children. However, there is a paucity of knowledge on how questions about family violence should be addressed within CHS. The aim of the study is to increase knowledge of the effectiveness of an evidence-based program within the Swedish CHS to identify family violence. The specific research question is: How can practice within CHS contribute to identification of family violence on routine or indication compared to treatment as usual?
A three-armed pragmatic randomized controlled trial (RCT) was conducted in 2017-2019 where all CHS's (n=120) in Region Stockholm were invited to participate. A total of 85 nurses from 22 CHC's participated in the trial of which 32 nurses from 10 CHS's were assigned the routine arm, 25 nurses from 5 CHS's were assigned the evidence based indication arm and 28 nurses from 7 CHS's were assigned to the treatment as usual group. Randomization was performed on CHS level so that the same approach was followed at each CHS when the first nurse was randomized. Only nurses in the routine and indication groups received training and supervision. The group that was assigned treatment as usual was offered the same training after the study was completed. The nurses completed questionnaires on the outcome knowledge, attitudes, and practices to identify and deal with family violence at three time points. Nurses in the two intervention groups also documented their practices and any identified cases of family violence during the intervention.
The findings of the study can contribute to knowledge on how children exposed to family violence can be identified and adequate measures be put in place.
- Being tested
- Routine questions, Questions on evidence based indication, Treatment as usual
- Keywords
- Family violence, Domestic violence, Intimate-partner violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine questionsProcedure or surgery
The routine group of nurses receive training and supervision and will ask questions about family violence to everyone, disregarding if they suspect family violence or not.
Questions on evidence based indicationProcedure or surgery
The group of nurses will receive training and supervision and will ask questions on evidence based indication
Treatment as usualProcedure or surgery
The group of nurses will ask questions when suspecting ongoing violence in the family
| Study group | Role | What they receive |
|---|---|---|
| Routine group | Experimental | Nurses within the routine group receive training and are assigned to inform about family violence at the home visit that takes place when the child is newborn and to by routine ask questions about family violence to mothers at the 6-8 weeks visit to CHC. Receives: Procedure: Routine questions |
| Indication group | Experimental | Nurses within the indication group receive training and are assigned to inform about family violence at the home visit when the child is newborn and to pose questions about family violence on evidence based indication. Receives: Procedure: Questions on evidence based indication |
| Treatment as usual | Active comparator | Nurses within the treatment as usual group do not receive training but ask questions when they suspect ongoing violence in the family. Receives: Procedure: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, attitudes and practices
An adaptation of the "Physician Readiness to Manage Violence Survey" developed by Short LM et al. (Am J Prev Med 2006; 30(2):173-180) and Ramsay J et al. (Brit J Gen Pract 2012; 62(602):647-655) was used. Higher values indicate more positive outcomes.
A subscale was used to measure knowledge about definition, prevalence and consequences of family violence (FV), summarized into a total value, with higher values indicating higher knowledge. Additional questions concerned knowledge of guidelines, reporting to social services and local interventions for children and parents.
Nurse's attitudes by asking about informing, asking questions about and acting upon FV.
Practices were measured by questions about how nurses provided or displayed information material, asked about FV and their reports of concern to social services.
Measured: Measured before randomization, within two weeks after training and six months post-training.
Secondary outcomes (1)
Number of cases of family violence
Documentation from nurses in the two intervention arms on number of identified cases of family violence
Measured: Documentation covers the intervention phase (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start23 Aug 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-armed study, two intervention groups and one control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Jane and Dan Olsson Foundation for Scientific Purposes, Region Stockholm
- Responsible party
- Principal investigator, Lene Lindberg, Karolinska Institutet
- Investigators
- Lene Lindberg, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299501
- Sponsor's protocol ID
- LS 2015-1199 and 2017-24
- Status last verified
- Mar 2024
- First submitted
- 18 Dec 2023
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Can Child Health Services Identify and Respond to Family Violence - a Randomized Controlled Trial to Assess the Effectiveness of Routine Questions or Questions Posed on Indication Compared to Treatment as Usual
- ClinicalTrials.gov ID
- NCT06299501
- Acronym / sponsor ID
- LS 2015-1199 and 2017-24
- Keywords
- Family violence, Domestic violence, Intimate-partner violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Jane and Dan Olsson Foundation for Scientific Purposes, Region Stockholm
- Study start
- 23 Aug 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 7 Mar 2024 (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.
Family violence has severe impacts on children's health and development. The Child Health Services (CHS) in Sweden reaches almost 100% of families with young children and provides a unique setting to facilitate identification of family violence. This study is a three-armed randomized controlled trial (RCT) conducted to assess the effectiveness of different approaches to identify family violence within CHS. Two different approaches are tested and compared to treatment as usual; 1) information about family violence at home visit when child is newborn, and questions posed to all mothers at the 6-8-week visit; 2) information about family violence at home visit when child is newborn, and questions posed to mothers on evidence based indication. Nurses who are randomized into any of the two intervention arms receive training and supervision. The outcomes of the study are related to knowledge, attitudes, and practices around identification and support in case of family violence and number of identified cases of family violence.
Detailed description
Family violence has severe impacts on children's health and development. Early identification of family violence is imperative to facilitate timely interventions. In Sweden, the Child Health Services (CHS) has a main aim to promote children's health and development and prevent ill health. The Swedish CHS program reaches almost 100% of families and includes 18 scheduled visits characterized by a health-promoting approach focusing on the child and the parents' wellbeing. The CHS offers a unique setting to identify family violence among families with young children. However, there is a paucity of knowledge on how questions about family violence should be addressed within CHS. The aim of the study is to increase knowledge of the effectiveness of an evidence-based program within the Swedish CHS to identify family violence. The specific research question is: How can practice within CHS contribute to identification of family violence on routine or indication compared to treatment as usual?
A three-armed pragmatic randomized controlled trial (RCT) was conducted in 2017-2019 where all CHS's (n=120) in Region Stockholm were invited to participate. A total of 85 nurses from 22 CHC's participated in the trial of which 32 nurses from 10 CHS's were assigned the routine arm, 25 nurses from 5 CHS's were assigned the evidence based indication arm and 28 nurses from 7 CHS's were assigned to the treatment as usual group. Randomization was performed on CHS level so that the same approach was followed at each CHS when the first nurse was randomized. Only nurses in the routine and indication groups received training and supervision. The group that was assigned treatment as usual was offered the same training after the study was completed. The nurses completed questionnaires on the outcome knowledge, attitudes, and practices to identify and deal with family violence at three time points. Nurses in the two intervention groups also documented their practices and any identified cases of family violence during the intervention.
The findings of the study can contribute to knowledge on how children exposed to family violence can be identified and adequate measures be put in place.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-armed study, two intervention groups and one control group
| Arm | Type | Receives |
|---|---|---|
| Routine group | Experimental | Procedure: Routine questionsNurses within the routine group receive training and are assigned to inform about family violence at the home visit that takes place when the child is newborn and to by routine ask questions about family violence to mothers at the 6-8 weeks visit to CHC. |
| Indication group | Experimental | Procedure: Questions on evidence based indicationNurses within the indication group receive training and are assigned to inform about family violence at the home visit when the child is newborn and to pose questions about family violence on evidence based indication. |
| Treatment as usual | Active comparator | Procedure: Treatment as usualNurses within the treatment as usual group do not receive training but ask questions when they suspect ongoing violence in the family. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Registered nurse
- Working in any of the Child Health Services in the Stockholm Region
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Routine questionsThe routine group of nurses receive training and supervision and will ask questions about family violence to everyone, disregarding if they suspect family violence or not. | Procedure or surgery | Routine group |
| Questions on evidence based indicationThe group of nurses will receive training and supervision and will ask questions on evidence based indication | Procedure or surgery | Indication group |
| Treatment as usualThe group of nurses will ask questions when suspecting ongoing violence in the family | Procedure or surgery | Treatment as usual |
Primary outcome
Knowledge, attitudes and practices
Time frame: Measured before randomization, within two weeks after training and six months post-training.
An adaptation of the "Physician Readiness to Manage Violence Survey" developed by Short LM et al. (Am J Prev Med 2006; 30(2):173-180) and Ramsay J et al. (Brit J Gen Pract 2012; 62(602):647-655) was used. Higher values indicate more positive outcomes. A subscale was used to measure knowledge about definition, prevalence and consequences of family violence (FV), summarized into a total value, with higher values indicating higher knowledge. Additional questions concerned knowledge of guidelines, reporting to social services and local interventions for children and parents. Nurse's attitudes by asking about informing, asking questions about and acting upon FV. Practices were measured by questions about how nurses provided or displayed information material, asked about FV and their reports of concern to social services.
1 secondary outcome
Number of cases of family violence
Time frame: Documentation covers the intervention phase (6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
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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 principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine questions, Questions on evidence based indication and Treatment as usual in people with Family Violence and Domestic 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: finished, as of the sponsor's last update on 8 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knowledge, attitudes and practices (time frame: Measured before randomization, within two weeks after training and six months post-training.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2024.