NCT06299501

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 7, 2024

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

December 18, 2023

Last Update Submit

March 7, 2024

Conditions

Keywords

Family violenceDomestic violenceIntimate-partner violence

Outcome Measures

Primary Outcomes (1)

  • 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 before randomization, within two weeks after training and six months post-training.

Secondary Outcomes (1)

  • Number of cases of family violence

    Documentation covers the intervention phase (6 months)

Study Arms (3)

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.

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.

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.

Procedure: Treatment as usual

Interventions

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.

Routine group

The group of nurses will receive training and supervision and will ask questions on evidence based indication

Indication group

The group of nurses will ask questions when suspecting ongoing violence in the family

Treatment as usual

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Registered nurse
  • Working in any of the Child Health Services in the Stockholm Region

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Child Health Care (Centrala barnhälsovården)

Stockholm, Sweden

Location

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Lene Lindberg

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Three-armed study, two intervention groups and one control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 18, 2023

First Posted

March 7, 2024

Study Start

August 23, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

March 8, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations