Promoting Safety Behaviours in Antenatal Care Using a Video

NCT ID: NCT03397277

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2020-09-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study investigates the effect of a video which teaches 15 safety behaviours for women subject to intimate partner violence (IPV) during pregnancy. Half of the women screening positive for IPV during pregnancy will view the intervention video. The other half will view a control video.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intimate partner violence (IPV) poses a risk for the health of the woman during pregnancy also for the health of the unborn child. Pregnancy is time when nearly all women have regular contact with the healthcare system. Pregnancy is also a time during which women consider their situation and are open for change.

Healthcare staff have the opportunity to ask pregnant women if they experience IPV and need to know how to respond to women experiencing IPV. Healthcare staff can refer to other services. If staff are uncertain if referral is needed or wanted they can teach women how to increase their own safety and prepare for leaving through a number of safety promoting behaviours.The safety behaviours were originally developed in the USA to counsel women who attended a family violence unit and qualified for a protection order.

Women do not always disclose the true nature of their IPV to staff. However, they could still benefit from learning about safety promoting behaviours. Using a video for teaching allows for the use of pictures and sound and options for several languages.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intimate Partner Violence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pregnant women will be screened for IPV using a modified version of the Abuse Assessment Screening. Women who screen positive are randomized into either the intervention video or a control video. Women screening negative for violence will be shown the control video. All women receive standard care and a card with high quality websites about safe pregnancy. Hidden among these is a webside that informs women about IPV (rights, safety etc..). Three months after birth all the women screening positive for violence will receive another questionnaire to fill out. In addition will a random sample of women who screened negative for IPV be asked to fill out a questionnaire at the same time. This group will be double the size of the women screening positive.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors
All women will be shown a video (also women not screening positive for IPV). Unless staff ask women about the content of the video or the women discloses this, care providers will not know which film participants have viewed. As we include a group of women who screened negative for IPV in the assessment three months after birth care providers will not know who who screened positive and who screened negative. In the file the variable for control og intervention video will be blinded. Women will be selected for the post-partum questionnaire based on the screening for abuse. All abused women and for each abused woman two without abuse will be selected.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Screened positive intervention video

Safety behaviour promoting video

Group Type EXPERIMENTAL

Safety behaviour promoting video

Intervention Type BEHAVIORAL

A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence

Screened positive control video

Pregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video

Group Type SHAM_COMPARATOR

Control video

Intervention Type BEHAVIORAL

A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Safety behaviour promoting video

A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence

Intervention Type BEHAVIORAL

Control video

A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* pregnant women attending antenatal care at the community health center,
* 18 years or older,
* understanding sufficient Norwegian, Urdu, Somali or English to complete the questionnaire and understand the video.

Exclusion Criteria

* women who do not speak or understand the languages provided in the study (English, Urdu, Somali and Norwegian)
* women who have never been in an adult intimate relationship
* women who are closely attended by male partner
* women who do not have the mental of physical capacity to answer the questionnaire.
* women who cannot fill out the questionnaire in privacy
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role collaborator

La Trobe University

OTHER

Sponsor Role collaborator

Oslo Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mirjam Lukasse

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mirjam Lukasse, PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo and Akershus University College

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Trøgstad Community Health Center

Askim, , Norway

Site Status

Nordberg

Ås, , Norway

Site Status

Ås Community Health Center

Ås, , Norway

Site Status

Rælingen Community Health Center

Flateby, , Norway

Site Status

Familie Hus Halden

Halden, , Norway

Site Status

Aurskog- Høland Community Health Center

Høland, , Norway

Site Status

Jevnaker Community Health Center

Jevnaker, , Norway

Site Status

Lillestrøm Communicy Health Center

Lillestrøm, , Norway

Site Status

Nesodden Community Health Center

Nesoddtangen, , Norway

Site Status

Oppegård Community Health Center

Oppegård, , Norway

Site Status

Grorud Community Health Center

Oslo, , Norway

Site Status

Bjerke Community Center

Oslo, , Norway

Site Status

Health Centre Alna

Oslo, , Norway

Site Status

Stovner Community Health Center

Oslo, , Norway

Site Status

Rakkestad Community Health Center

Rakkestad, , Norway

Site Status

Skedsmo Community Health Center

Skedsmokorset, , Norway

Site Status

Langhus

Ski, , Norway

Site Status

Ski Community Health Center

Ski, , Norway

Site Status

Våler Community Health Center

Våler, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

References

Explore related publications, articles, or registry entries linked to this study.

Flaathen EME, Henriksen L, Smastuen MC, Schei B, Taft A, Noll J, Garnweidner-Holme L, Lukasse M. Safe Pregnancy intervention for intimate partner violence: a randomised controlled trial in Norway among culturally diverse pregnant women. BMC Pregnancy Childbirth. 2022 Feb 21;22(1):144. doi: 10.1186/s12884-022-04400-z.

Reference Type DERIVED
PMID: 35189843 (View on PubMed)

Walter B, Indreboe H, Lukasse M, Henriksen L, Garnweidner-Holme L. Pregnant Women's Attitudes Toward and Experiences With a Tablet Intervention to Promote Safety Behaviors in a Randomized Controlled Trial: Qualitative Study. JMIR Form Res. 2021 Jul 20;5(7):e28680. doi: 10.2196/28680.

Reference Type DERIVED
PMID: 34283023 (View on PubMed)

Garnweidner-Holme L, Henriksen L, Flaathen EM, Klette Bohler T, Lukasse M. Midwives' Attitudes Toward and Experience With a Tablet Intervention to Promote Safety Behaviors for Pregnant Women Reporting Intimate Partner Violence: Qualitative Study. JMIR Mhealth Uhealth. 2020 May 20;8(5):e16828. doi: 10.2196/16828.

Reference Type DERIVED
PMID: 32432553 (View on PubMed)

Henriksen L, Flaathen EM, Angelshaug J, Garnweidner-Holme L, Smastuen MC, Noll J, Taft A, Schei B, Lukasse M. The Safe Pregnancy study - promoting safety behaviours in antenatal care among Norwegian, Pakistani and Somali pregnant women: a study protocol for a randomized controlled trial. BMC Public Health. 2019 Jun 10;19(1):724. doi: 10.1186/s12889-019-6922-y.

Reference Type DERIVED
PMID: 31182062 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

260355

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Brief Intervention in At-Risk First-time Mothers
NCT00230009 COMPLETED PHASE1/PHASE2