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Trial record 61 of 136 for:    (domestic or partner) AND (violence OR abuse)

Primary Prevention of Intimate Partner Violence in India

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ClinicalTrials.gov Identifier: NCT03332134
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
National AIDS Research Institute, India
Information provided by (Responsible Party):
Ameeta Kalokhe, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: Intimate Partner Violence (IPV) Prevention Intervention Not Applicable

Detailed Description:

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Primary Prevention of Intimate Partner Violence in India
Actual Study Start Date : January 18, 2018
Actual Primary Completion Date : October 9, 2018
Actual Study Completion Date : October 9, 2018

Arm Intervention/treatment
Experimental: Married Couple Dyad
Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks.
Behavioral: Intimate Partner Violence (IPV) Prevention Intervention
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.

No Intervention: Control Group
Husband-wife dyads in the control group will not receive an intervention.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332134


Locations
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India
National AIDS Research Institute
Pune, Maharashtra, India, 411026
Sponsors and Collaborators
Emory University
National AIDS Research Institute, India
Investigators
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Principal Investigator: Ameeta Kalokhe, MD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ameeta Kalokhe, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03332134     History of Changes
Other Study ID Numbers: IRB00069846
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No