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

NCT04978064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-01-10

No results posted yet for this study

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. estimate rates of consent to randomization, and the rates of adherence and dropout following randomization (for the use in sample size estimation)
2. determine recruitment duration
3. examine the women's perception about the benefit of the intervention
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

Interventions

BEHAVIORAL

e-health psychological counselling

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).

Sponsors & Collaborators

  • University of Southern Denmark

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Universidad de Granada

    lead OTHER

Principal Investigators

  • Khalid S. Khan · Universidad de Granada

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2022-11-14
Completion
2022-11-14

Countries

  • Denmark
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04978064 on ClinicalTrials.gov