Strenghts and limitations of the pilot RCT

Multidisciplinary Assessment & Feasibility Study

This document describes a summary of the results of a pilot randomised controlled trial (RCT)
conducted in Denmark and Spain and its strengths and limitations (deliverable D5.3. describes in
more detail the results of the pilot RCT). It also contains propositions for future study designs
based on a review of the relevant literature as the pilot RCT demonstrated that a future full-scale
randomised study was unfeasible. In our pilot study, a subset of women from the STOP cohort
study who screened positive for IPV during their first antenatal visit were invited to participate in
pilot randomised controlled trial of psychological counselling by video conference. The objective
was to randomise a total number of 20 participants to either the intervention or the control
group. The intervention group received the e-health package (six video counselling sessions
combined with the use of a safety planning app), while the control group would receive the same
intervention yet with a delay of 8 weeks permitting collection of control outcome data. This
document will interpret the pilot findings and the existing literature to come up with possible
solutions to address the difficulties in the feasibility of a future full-scale randomised study
observed in the pilot study.


Find the deliverable here: STOP D5.2 vs 2

Ethical Approval

Multidisciplinary Assessment & Feasibility Study

The ethical approval applications have been submitted to the local Ethics Committees at the Danish and Spanish sites, respectively. The descriptions provide information on the background of the project, its aims, methodology with sub-studies, needs assessment, anticipated risks, access to patient information, informed consent, impact, funding, the ethics, safety and security of the project, the members of the research team, and relevant references. At the Spanish site, ethical approval has been received for the screening solution while approval for the video counseling solution is still pending. At the Danish site, the screening solution has been implemented throughout the region and thus no ethical approval is needed, and the ethics committee determined that approval was unnecessary for the video counseling intervention.


As the deliverable is confidential, it has not been made available here.

STOP Data Collection

Multidisciplinary Assessment & Feasibility Study

As part of the STOP, a report has been prepared to present the data collection across the two sites.

The report provides an overview of the data collection in the context of WP4. Here, you will find an overview of the study population followed by a description of the STOP interventions and training of midwives and psychologist for the data collection. Furthermore, it provides a description of the qualitative data collection, the management of the data and monitoring of the intervention, and ethical considerations in relation to the data collection.



Find the deliverable here: STOP D4-2 v2