- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06299501
How Can Child Health Services Identify and Respond to Family Violence
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Stockholm, Sweden
- Central Child Health Care (Centrala barnhälsovården)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered nurse
- Working in any of the Child Health Services in the Stockholm Region
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Routine group
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.
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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.
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Experimental: Indication group
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.
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The group of nurses will receive training and supervision and will ask questions on evidence based indication
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Active Comparator: Treatment as usual
Nurses within the treatment as usual group do not receive training but ask questions when they suspect ongoing violence in the family.
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The group of nurses will ask questions when suspecting ongoing violence in the family
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge, attitudes and practices
Time Frame: Measured before randomization, within two weeks after training and six months post-training.
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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 before randomization, within two weeks after training and six months post-training.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of cases of family violence
Time Frame: Documentation covers the intervention phase (6 months)
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Documentation from nurses in the two intervention arms on number of identified cases of family violence
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Documentation covers the intervention phase (6 months)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lene Lindberg, Karolinska Institutet
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LS 2015-1199 and 2017-24
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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