E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV)

NCT04978064 | Completed DMC

• 3 other identifiers: eIPV20216713311620212000-80
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

Brief Summary

The investigators will assess the need and feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy in a full-scale future randomised trial. To achieve this, the investigators will:

1. 1.estimate rates of consent to randomization, and the rates of adherence and dropout following randomization (for the use in sample size estimation)
2. 2.determine recruitment duration
3. 3.examine the women's perception about the benefit of the intervention
4. 4.determine the reasons for acceptability, non-adherence, and obstacles to recruitment, randomisation and consent through qualitative interviews

Conditions

Pregnancy Related; Violence, Gender-Based; Intimate Partner Violence

Keywords

pilot randomized controlled trial; pregnancy; intimate partner violence; e-health intervention; counselling

Outcome Measures

Primary Outcomes (1)

• Consent rate for a future full-scale RCT trial

  Rate of women who were positive in IPV, consent to receive e-health package and consent to randomization in the control group.

  Three to nine months

Secondary Outcomes (8)

• Positivity rate of the cohort study (useful for planning the future full-scale randomised control trial):

  Three to nine months

• Completion rate in the intervention group a future full-scale RCT trial

  Three to nine months

• Completion rate in the control group a future full-scale RCT trial

  Three to nine months

• Recruitment duration for a future full-scale RCT trial

  Three to nine months

• Benefit of the intervention a future full-scale RCT trial

  Three to nine months

Study Arms (2)

Intervention group

EXPERIMENTAL

Behavioral e-health psychological counselling

Behavioral: e-health psychological counselling

Control group

OTHER

Usual care (delayed behavioral e-health psychological counselling)

Behavioral: e-health psychological counselling

Interventions

e-health psychological counselling BEHAVIORAL

Intervention group: Women positive for IPV who accept the e-Health intervention and who have been randomly allocated in the intervention group will receive the e-health package as the rest of the cohort, as well as the baseline and outcome measurements. The e-health package will include six video counselling sessions by trained providers and the access to a mobile application for designing security plans, an adapted version of the mobile application "My Plan". The content of the six individually tailored sessions will be based on the Dutton's Empowerment Model and the Psychosocial Readiness Model. Control group: women positive in IPV who accept the e-Health intervention package will be asked for a second consent to receive a delayed intervention (8 weeks later) and to complete as the baseline and outcome measurements. Women can request to leave the control group at any time and to receive the intervention immediately (in which case they data will be part of the cohort study).

Control group; Intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women at \<12 weeks gestation, who screen positive in IPV at the first antenatal visit and accept the e-health package.

You may not qualify if:

• Women who cannot be informed about the study without their partners or other family members knowing
• Women mentally or physically incapacity to participate in the study
• Women below 16 years in Spain or below 18 years in Denmark
• Inability to understand Danish/Spanish
• Lack of internet and electronic device
• Women with extreme severity of IPV. Women selected to participate in the trial in this situation will receive a danger assessment before randomisation and if the severity of IPV is confirmed, they will be routinely treated and supported according to the standard protocol in each country. Women who have same-sex partners will be screened, but their data will not be used for the purpose of this study.

Sponsors & Collaborators

• Universidad de Granada: lead
• University of Southern Denmark: collaborator
• Odense University Hospital: collaborator

Study Sites (2)

Odense University Hospital

Odense, Denmark

Location

University of Granada

Granada, Spain

Location

Related Publications (3)

• Martin-de-Las-Heras S, Velasco C, Luna-Del-Castillo JD, Khan KS. Breastfeeding avoidance following psychological intimate partner violence during pregnancy: a cohort study and multivariate analysis. BJOG. 2019 May;126(6):778-783. doi: 10.1111/1471-0528.15592. Epub 2019 Jan 24.

  PMID: 30575266 BACKGROUND

• Roman-Galvez RM, Martin-Pelaez S, Martinez-Galiano JM, Khan KS, Bueno-Cavanillas A. Prevalence of Intimate Partner Violence in Pregnancy: An Umbrella Review. Int J Environ Res Public Health. 2021 Jan 15;18(2):707. doi: 10.3390/ijerph18020707.

  PMID: 33467538 BACKGROUND

• Rasch V, Van TN, Nguyen HTT, Manongi R, Mushi D, Meyrowitsch DW, Gammeltoft T, Wu CS. Intimate partner violence (IPV): The validity of an IPV screening instrument utilized among pregnant women in Tanzania and Vietnam. PLoS One. 2018 Feb 1;13(2):e0190856. doi: 10.1371/journal.pone.0190856. eCollection 2018.

  PMID: 29389954 BACKGROUND

Study Officials

• Khalid S. Khan

  Universidad de Granada

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Women in the intervention group will be blinded but not women in the control group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A pilot randomised controlled trial (RCT), co-designed by patient input using a modified Zelen's design with additional qualitative evaluation, will be nested within a cohort study.

Study Record Dates

• First Submitted: July 4, 2021
• First Posted: July 27, 2021
• Study Start: October 7, 2021
• Primary Completion: November 14, 2022
• Study Completion: November 14, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Starting 6 months after publication
• Access Criteria: On reasonable request, protocol, data collection forms and published results are available from investigators. Sharing would need to be comply with data protection laws.

Locations

DK (1); ES (1)