Promoting Safety Behaviours in Antenatal Care Using a Video

NCT03397277 | Completed

• 1 other identifier: 260355
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 19

Brief 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.

Conditions

Intimate Partner Violence

Keywords

IPV

Outcome Measures

Primary Outcomes (2)

• Adoption of safety behaviours

  Number of used safety behaviours

  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.

  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)

  change from pregnancy to 3 months postpartum

• Symptoms of depression

  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.

Other Outcomes (5)

• Mode of delivery

  at birth

• Birth weight

  at birth

• Initiation and early cessation of breastfeeding

  approximately 3 months postpartum

Study Arms (2)

Screened positive intervention video

EXPERIMENTAL

Safety behaviour promoting video

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

Behavioral: Control video

Interventions

Safety behaviour promoting video BEHAVIORAL

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

Screened positive intervention video

Control video BEHAVIORAL

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

Screened positive control video

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Only women are pregnant so only women can be recruited to this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• University of Oslo: collaborator
• Norwegian University of Science and Technology: collaborator
• La Trobe University: collaborator

Study Sites (19)

Trøgstad Community Health Center

Askim, Norway

Location

Nordberg

Ås, Norway

Location

Ås Community Health Center

Ås, Norway

Location

Rælingen Community Health Center

Flateby, Norway

Location

Familie Hus Halden

Halden, Norway

Location

Aurskog- Høland Community Health Center

Høland, Norway

Location

Jevnaker Community Health Center

Jevnaker, Norway

Location

Lillestrøm Communicy Health Center

Lillestrøm, Norway

Location

Nesodden Community Health Center

Nesoddtangen, Norway

Location

Oppegård Community Health Center

Oppegård, Norway

Location

Grorud Community Health Center

Oslo, 0905, Norway

Location

Bjerke Community Center

Oslo, Norway

Location

Health Centre Alna

Oslo, Norway

Location

Stovner Community Health Center

Oslo, Norway

Location

Rakkestad Community Health Center

Rakkestad, Norway

Location

Skedsmo Community Health Center

Skedsmokorset, Norway

Location

Langhus

Ski, Norway

Location

Ski Community Health Center

Ski, Norway

Location

Våler Community Health Center

Våler, Norway

Location

Related Publications (4)

• 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.

  PMID: 35189843 DERIVED

• 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.

  PMID: 34283023 DERIVED

• 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.

  PMID: 32432553 DERIVED

• 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.

  PMID: 31182062 DERIVED

Study Officials

• Mirjam Lukasse, PhD

  Oslo and Akershus University College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: January 11, 2018
• Study Start: January 15, 2018
• Primary Completion: June 30, 2020
• Study Completion: September 15, 2020
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (19)