Testing the Effectiveness of a Safety-promoting Intervention in Antenatal Care

Sponsor

Norwegian University of Science and Technology (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05199935

Collaborator

Kathmandu Medical College and Teaching Hospital (Other), Kathmandu University School of Medical Sciences (Other), University of South-Eastern Norway (Other)

2,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have modified the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed to be used alongside an individual counselling session for women screening positively for domestic violence. This study aims to investigate the effect of the video and counselling session compared to standard care.

Condition or Disease	Intervention/Treatment	Phase
Domestic Violence	Behavioral: Video and counselling Other: Control	N/A

Detailed Description

This randomized controlled study is a two armed study, which will take place at two locations. Eligible women will be invited to the study when attending routine antenatal care. Women agreeing to participate will be invited to first complete a questionnaire. Upon completion of this first questionnaire women are allocated to either the intervention or control arm, irrespective of their Domestic Violence (DV) Status. In the intervention arm all women will be shown the intervention video, irrespective of their DV status. Women who screened positive on domestic violence will be offered a short counselling session following the viewing of the video. In the control arm women receive standard care only. All women are asked to return to the study during the last two months of their pregnancy. All women will be asked to complete the second questionnaire. Upon completions all women will be offered to see the intervention video. For the intervention group this will be their second viewing, for the control group this will be the first viewing. All women will be followed up til birth. Data about their birth will be collected from their hospital records.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A two armed randomized controlled trialA two armed randomized controlled trial

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description:

All participants experiencing domestic violence will view the video but at different times so they will not know who is in the intervention group or not. Care providers will provide standard care and not know which group women in unless they specifically ask at which point the woman viewed a video and if she talked to someone in person after viewing the video. The data-set will be masked so that the statistician analyzing will not know the code for the two different groups.

Primary Purpose:

Prevention

Official Title:

A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Video and counselling Are shown the intervention video and those who screened positive for domestic violence are given a personal follow-up session.	Behavioral: Video and counselling Women are encouraged to share their experience of domestic violence with others.
Other: Control Receive standard care. Are not shown the intervention video at Time 1, baseline but are shown the video after main outcome data is collected at Time 2	Other: Control Standard care

Arm

Intervention/Treatment

Experimental: Video and counselling

Are shown the intervention video and those who screened positive for domestic violence are given a personal follow-up session.

Behavioral: Video and counselling

Women are encouraged to share their experience of domestic violence with others.

Other: Control

Receive standard care. Are not shown the intervention video at Time 1, baseline but are shown the video after main outcome data is collected at Time 2

Other: Control

Standard care

Outcome Measures

Primary Outcome Measures

Seeking support [12 to 24 weeks after intervention]
A single question asking women if they have told anybody about the experience of domestic violence besides the person at the personal follow-up at Time 1 (baseline)

Secondary Outcome Measures

Ways of Coping Checklist [12 to 24 weeks after intervention]
Sub-scales seeking social support, avoidance and detachment, self-blame
Use of safety measures [12 to 24 weeks after intervention]
Measures women can take to prepare for leaving or reduce violence

Other Outcome Measures

Edinburgh Depression Scale [12 to 24 weeks after intervention]
Symptoms of depression
Attitudes towards domestic violence [12 to 24 weeks after intervention]
6 items from the Social Acceptance of Wife Abuse Scale (SAWAS). Minimum score is 0 (zero) and maximum score is 3. A higher score is a worse outcome.
Attitudes towards domestic violence [12 to 24 weeks after intervention]
WHO set of questions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

between 12 to 20 weeks gestational age of pregnancy

Exclusion Criteria:

prior 12 weeks gestation
after 20 weeks of pregnancy
mentally unable to participate

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Norwegian University of Science and Technology
Kathmandu Medical College and Teaching Hospital
Kathmandu University School of Medical Sciences
University of South-Eastern Norway

Investigators

Principal Investigator: Schei Berit, PhD, Norwegian University of Science and Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT05199935

Other Study ID Numbers:

178092

First Posted:

Jan 20, 2022

Last Update Posted:

Aug 4, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Norwegian University of Science and Technology

Pregnancy

Nepal

Study Results

No Results Posted as of Aug 4, 2022