Viewing Study NCT06299501



Ignite Creation Date: 2024-05-06 @ 8:12 PM
Last Modification Date: 2024-10-26 @ 3:23 PM
Study NCT ID: NCT06299501
Status: COMPLETED
Last Update Posted: 2024-03-08
First Post: 2023-12-18

Brief Title: How Can Child Health Services Identify and Respond to Family Violence
Sponsor: Karolinska Institutet
Organization: Karolinska Institutet

Study Overview

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
Status: COMPLETED
Status Verified Date: 2024-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Family violence has severe impacts on childrens 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 childrens 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 childrens 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 CHSs n120 in Region Stockholm were invited to participate A total of 85 nurses from 22 CHCs participated in the trial of which 32 nurses from 10 CHSs were assigned the routine arm 25 nurses from 5 CHSs were assigned the evidence based indication arm and 28 nurses from 7 CHSs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None