Health TrialsbyHealthPanel

The Primary Prevention of Intimate Partner Violence

ConditionIntimate Partner Violence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEmory University

About this trial

This is a cluster randomized trial for newly married dyads, that seeks to quantify the impact of GBE's (Ghya Bharaari Ekatra's) intervention on intimate partner violence (IPV) and downstream outcomes, mental health and reproductive autonomy, examine its mechanism of action, contexts in which it may need modification, and factors associated with its future successful adoption and implementation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

couples wherein both members are age ≥18 years,

married ≤ 1 year, in their first marriage, married to only one individual, cohabiting in a slum in Mumbai or Pune India, and

fluent in Marathi and/or Hindi

Both members of the couple must meet eligibility criteria and be present at the session for the couple to participate.

Disqualifiers

As GBE was designed for primary IPV prevention, couples in which the female member screens positive for physical and/or sexual IPV (using the modified Conflict Tactics Scale (CTS-2)) at baseline will be excluded (and referred to support services)

those in the 3rd trimester of pregnancy (as women traditionally return to their natal home during this perinatal period).

Trial design

Design model

Parallel

Treatments tested in this trial

  • GBE (Ghya Bharaari Ekatra) intervention

    Behavioral

    Ghya Bharaari Ekatra (Marathi for "Take a flight together") intervention The intervention consists of six sessions. Each session will cover one of 6 major modules to enhance transformation of motivation: 1) You, Me, and Us: Spending Meaningful Time Together, 2) I'm a Champion: I Can't Be Broken and I don't Accept Defeat! 3) Building Communication and conflict management strategies, and 4) Empowerment of the Couple: Planning Ahead, 5) Sexual communication and the sexual relationships, and 6) A Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of sessions are 2 hours. GBE will be delivered to a total of 500 dyads.

  • Ethical standard of care

    Behavioral

    Ethical standard of care includes information on IPV and mental and reproductive/sexual health resources) to prevent IPV experience. This intervention will be delivered to a total of 350 dyads.

Treatment groups

1,700 Participants
are divided into 2 treatment groups
Group A: GBE (Ghya Bharaari Ekatra) GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intimate Partner Violence (IPV) Experience

IPV experience is defined as a woman experiencing one or more act of physical, sexual, and/or psychological IPV.

Time frame
12 months post intervention

Secondary outcomes

1

Change in General Health Questionnaire-12 (GHQ-12) Score

Mental health is assessed using the General Health Questionnaire-12 (GHQ-12). The GHQ-12 is scored using a 4-point Likert scale, where each item is assigned a value from 0 to 3, resulting in a total score ranging from 0 to 36, with higher scores indicating greater psychological distress.

Time frame
Baseline, 6 and 12 months post intervention
2

Change in Reproductive Autonomy Scale (RAS) Score

Reproductive autonomy among women is measured using a culturally-tailored version of the Reproductive Autonomy Scale (RAS). The RAS is a 14-item self-reported measure of individual experiences of ability to achieve reproductive goals, comprising of three domains: Decision-making, Freedom from Coercion, and Communication. The Decision-making subscale uses a 3-point Likert scale, where each item is assigned a value of 1 to 3. The Freedom from Coercion and Communication Subscales use a 4-point Likert scale, where each item is assigned a value of 1 to 4. Item scores are averaged to calculate subscale and total measure scores. Higher scores indicate greater levels of autonomy.

Time frame
Baseline, 6 and 12 months post intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: