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

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

Detailed Description
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Introduction. Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. Among mothers exposed to IPV, e-health interventions during pregnancy may be beneficial. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the need and feasibility of randomising a sufficiently large number of women at exposed to IPV during pregnancy. Methods. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers at <12 weeks' gestation who screen positive for IPV in the first antenatal visit and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. The investigators will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women's perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial. Comment. The pilot study nested within the cohort study will allow us to obtain information about the rates of IPV in pregnancy, the acceptability of an e-health intervention and the availability of participants for randomisation into a large effectiveness trial.

Official Title
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E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV): a Pilot Randomised Controlled Trial

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

Intervention / Treatment
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* Behavioral: e-health psychological counselling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Pregnant women at <12 weeks gestation, who screen positive in IPV at the first antenatal visit and accept the e-health package. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Behavioral e-health psychological counselling | Behavioral: e-health psychological counselling<br>* 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).<br>|
| Other: Control group<br>Usual care (delayed behavioral e-health psychological counselling) | Behavioral: e-health psychological counselling<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positivity rate of the cohort study (useful for planning the future full-scale randomised control trial): | Rate of women who were positive in IPV and consent to receive e-health package | Three to nine months | 
| Completion rate in the intervention group a future full-scale RCT trial | Rate of women who were recruited to intervention group, and for whom complete outcomes were obtained. | Three to nine months | 
| Completion rate in the control group a future full-scale RCT trial | Rate of women who were recruited to control group, and for whom complete outcomes were obtained. | Three to nine months | 
| Recruitment duration for a future full-scale RCT trial | Recruitment duration (in days) to get the pilot sample (5 women for the intervention group and 5 women for the control group, in each country) | Three to nine months | 
| Benefit of the intervention a future full-scale RCT trial | Perception of the intervention by women participating in the pilot through the information obtained in qualitative interviews. | Three to nine months | 
| Perception about the delay of the intervention of the control group for a future full-scale RCT trial | Perception about the duration of delay of the intervention of women in the control group (provided in the qualitative interviews). | Three to nine months | 
| Reasons for acceptability, non-adherence, and obstacles for a future full-scale RCT trial | Reasons for acceptability, non-adherence, and obstacles to recruitment, randomization, consent and follow-up (provided in the qualitative interviews). | Three to nine months | 
| Follow up rate for a future full-scale RCT trial | Rate of failure to obtain data in the follow-up. | Three to nine months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pilot randomized controlled trial, pregnancy, intimate partner violence, e-health intervention, counselling