Intimate Partner ViolenceNCT03397277
Promoting Safety Behaviours in Antenatal Care Using a Video
A study testing Safety behaviour promoting video in people with Intimate Partner Violence, run by Oslo Metropolitan University at 19 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Safety behaviour promoting video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 19 sitesNorway
- Study dates
- 15 Jan 2018to 15 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Norway19 sites
Nordberg
Ås
Ås Community Health Center
Ås
Trøgstad Community Health Center
Askim
Rælingen Community Health Center
Flateby
Familie Hus Halden
Halden
Aurskog- Høland Community Health Center
Høland
Jevnaker Community Health Center
Jevnaker
Lillestrøm Communicy Health Center
Lillestrøm
Nesodden Community Health Center
Nesoddtangen
Oppegård Community Health Center
Oppegård
Grorud Community Health Center
Oslo, 0905
Bjerke Community Center
Oslo
Health Centre Alna
Oslo
Stovner Community Health Center
Oslo
Rakkestad Community Health Center
Rakkestad
Skedsmo Community Health Center
Skedsmokorset
Langhus
Ski
Ski Community Health Center
Ski
Våler Community Health Center
Våler
About this study
Official title: Preparing for the Worst - Promoting Safety Behaviours in Antenatal Care Among Norwegian, Pakistani and Somali Pregnant Women
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.
Read the detailed description
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
- Intimate Partner Violence
- Being tested
- Safety behaviour promoting video, Control video
- Keywords
- IPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety behaviour promoting videoBehavioural
A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence
Control videoBehavioural
A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Screened positive intervention video | Experimental | Safety behaviour promoting video Receives: Behavioral: Safety behaviour promoting video |
| Screened positive control video | Sham comparator | Pregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video Receives: Behavioral: Control video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adoption of safety behaviours
Number of used safety behaviours
Measured: change from pregnancy to 3 months postpartum
The World Health Organisation Quality of Life Brief (WHOQOL-BREF)
A scale of 26 items assessing four dimensions of quality of life (QOL), physical, psychological, environmental and social. Low score equals low QOL. Mean scores are calculated for each domain.
Measured: Change from pregnancy to 3 months postpartum
Secondary outcomes (2)
Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)
CAS(R)-SF is a 15-item instrument capturing physical, sexual and psychological abuse and overall IPV. Total score ranges from 0 to 75. Low score indicates less violence. Mean total score is calculated and compared.
Measured: change from pregnancy to 3 months postpartum
Symptoms of depression
Edinburgh Depression Scale -5 (short version)
Measured: Change from pregnancy to 3 months postpartum. Minimum score is 0, maximum score is 15. The lower the score the fewer symptoms of depression the person has. A cut-off of 7 or more is used to indicate symptoms of depression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start15 Jan 2018
- Primary completion30 Jun 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Norwegian University of Science and Technology, La Trobe University
- Responsible party
- Principal investigator, Mirjam Lukasse, Oslo Metropolitan University
- Investigators
- Mirjam Lukasse, PhD, Principal investigator, Oslo and Akershus University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397277
- Sponsor's protocol ID
- 260355
- Status last verified
- Sep 2020
- First submitted
- 24 Oct 2017
- Last updated
- 21 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35189843Walter 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.
PubMed 34283023Garnweidner-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.
PubMed 32432553Henriksen 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.
PubMed 31182062
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preparing for the Worst - Promoting Safety Behaviours in Antenatal Care Among Norwegian, Pakistani and Somali Pregnant Women
- ClinicalTrials.gov ID
- NCT03397277
- Acronym / sponsor ID
- 260355
- Conditions
- Intimate Partner Violence
- Keywords
- IPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Oslo, Norwegian University of Science and Technology, La Trobe University
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 11 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Screened positive intervention video | Experimental | Behavioral: Safety behaviour promoting videoSafety behaviour promoting video |
| Screened positive control video | Sham comparator | Behavioral: Control videoPregnant women who screen positive for IPV using the AAS who are randomized into viewing the control video |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety behaviour promoting videoA 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence | Behavioural | Screened positive intervention video |
| Control videoA 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy | Behavioural | Screened positive control video |
Primary outcome
Adoption of safety behaviours
Time frame: change from pregnancy to 3 months postpartum
Number of used safety behaviours
The World Health Organisation Quality of Life Brief (WHOQOL-BREF)
Time frame: Change from pregnancy to 3 months postpartum
A scale of 26 items assessing four dimensions of quality of life (QOL), physical, psychological, environmental and social. Low score equals low QOL. Mean scores are calculated for each domain.
2 secondary outcomes
Prevalence of Intimate Partner Violence (IPV) measured using Composite Abuse Scale (revised) - Short Form (CAS R SF)
Time frame: change from pregnancy to 3 months postpartum
Symptoms of depression
Time frame: Change from pregnancy to 3 months postpartum. Minimum score is 0, maximum score is 15. The lower the score the fewer symptoms of depression the person has. A cut-off of 7 or more is used to indicate symptoms of depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Derived from this study: PubMed 35189843Flaathen 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.
- Derived from this study: PubMed 34283023Walter 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.
- Derived from this study: PubMed 32432553Garnweidner-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.
- Derived from this study: PubMed 31182062Henriksen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirjam Lukasse, PhD principal investigator
Oslo and Akershus University College
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety behaviour promoting video in people with Intimate Partner Violence, run by Oslo Metropolitan University at 19 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adoption of safety behaviours (time frame: change from pregnancy to 3 months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03397277, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.