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Completed

NCT Number: NCT03332134

Primary Prevention of Intimate Partner Violence in India

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National AIDS Research Institute

Pune, Maharashtra, 411026, India

About this study

The goal of this study is to test and evaluate the feasibility, acceptance, safety, and efficacy of an an intimate partner violence (IPV) intervention in recently-married, low-income husband-wife dyads in Pune, India conducted over a six week period.

Acceptability and feasibility will be assessed through semi-structured interviews with participants and staff post-intervention. Safety will be gauged through semi-structured interviews with women participants and efficacy will be gauged through change in proximal determinants of IPV in this population (i.e. time spent in the relationship, self-esteem, resilience, communication and conflict management skills, sexual communication, attitudes toward IPV acceptability, and conceptualization of IPV).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recently married (i.e. <1 year) husband-wife dyads
  • First marriage
  • Planning to reside in Pune for the majority of the next 6 months
  • Marathi fluency
  • Lives with partner
  • Lives in a slum, slum redevelopment community, or chawl

Exclusion criteria

  • Pregnant in third trimester of pregnancy
  • Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form

Treatment and study plan

Intimate Partner Violence (IPV) Prevention Intervention

Behavioral

The IPV 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 session 1, 2-6, and the 3-month follow-up are 120 minutes, and 60-90 minutes, respectively.

Primary outcomes

  1. IPV Intervention Acceptability

    Time frame: Duration of Study (Up to 3 Months)

    Acceptability of the intervention to the dyad will be collected qualitatively and gauged by extracting themes regarding acceptability of modular content, timing of the intervention, safety precautions, number and duration of the intervention sessions, and appropriateness of intervention staff through semi-structured interviews between administrators and participants.

  2. IPV Intervention Feasibility

    Time frame: Duration of Study (Up to 3 Months)

    Intervention feasibility will be qualitatively assessed by extracting themes from post-session semi-structured interviews of difficulties in intervention delivery, participant understanding of the intervention, and logistical problems with the intervention setting, timing, staff training, and debriefings as reported by the intervention administrator.

  3. IPV Intervention Safety

    Time frame: Duration of Study (Up to 3 Months)

    Safety of the intervention will be gauged by extracting themes of incident IPV events or changes in IPV frequency or severity reported by the wife at the three-month follow-up through semi-structured interviews between administrators and participants.

Secondary outcomes

  1. Change in Time Spent Together

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in time spent together alone with partner

  2. Change in Self-esteem

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in score on Rosenberg Self-esteem Scale. The scale measures self-esteem on a scale of 0-30 (wherein lower scores are suggestive of lower self-esteem).

  3. Change in Communication Skills

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in confidence in communicating about various commonly-encountered scenarios with partner

  4. Change in Conflict Negotiation Skills

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in Revised Conflict Tactics Scale (CTS2) Negotiation Subscale score. The negotiation subscale measure actions taken to settle disagreements. The minimum score is 0 and the maximum is 150, with higher scores suggestive of better negotiation skills.

  5. Change in Sexual Communication Skills

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in confidence in communicating to partner desire to have or not have sex

  6. Change in Reproductive Health Beliefs linked to IPV

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in commonly held sexual and reproductive health beliefs linked to IPV perpetration.

  7. Change in Conceptualization of IPV

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in acknowledgement of behaviors that constitute IPV. This outcome is assessed using an adaptation of the Indian Family Violence and Control Scale, wherein response choices will include "not violence," "mild violence," "moderate violence, and "severe violence." The minimal score will be 12 and the maximum 48, with greater scores being suggestive of the participant having a more comprehensive conceptualization of behaviors constituting IPV.

  8. Change in Attitudes toward IPV Acceptability

    Time frame: Baseline, Post-Intervention (3 Months)

    Change in attitudes toward situations in which beating a partner may be acceptable. This outcome is assessed using adapted questions from the National Family Health Survey Attitudes Towards Wife Beating module. It is assessed based on the frequency of affirmative responses to the questions, with more affirmative responses being associated with greater acceptance of IPV.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National AIDS Research Institute, India

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 6, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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