Intimate Partner ViolenceNCT03332134
Primary Prevention of Intimate Partner Violence in India
A study testing Intimate Partner Violence (IPV) Prevention Intervention in people with Intimate Partner Violence, run by Emory University at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- Intimate Partner Violence (IPV) Prevention Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 18 Jan 2018to 9 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant in third trimester of pregnancy
- Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form
Trial locations and contacts
1 site in 1 country.
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.
Read the 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).
- Conditions
- Intimate Partner Violence
- Being tested
- Intimate Partner Violence (IPV) Prevention Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intimate Partner Violence (IPV) Prevention InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Married Couple Dyad | Experimental | Husband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks. Receives: Behavioral: Intimate Partner Violence (IPV) Prevention Intervention |
| Control Group | No intervention | Husband-wife dyads in the control group will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPV Intervention Acceptability
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.
Measured: Duration of Study (Up to 3 Months)
IPV Intervention Feasibility
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.
Measured: Duration of Study (Up to 3 Months)
IPV Intervention Safety
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.
Measured: Duration of Study (Up to 3 Months)
Secondary outcomes (8)
Change in Time Spent Together
Change in time spent together alone with partner
Measured: Baseline, Post-Intervention (3 Months)
Change in Self-esteem
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).
Measured: Baseline, Post-Intervention (3 Months)
Change in Communication Skills
Change in confidence in communicating about various commonly-encountered scenarios with partner
Measured: Baseline, Post-Intervention (3 Months)
Change in Conflict Negotiation Skills
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.
Measured: Baseline, Post-Intervention (3 Months)
Change in Sexual Communication Skills
Change in confidence in communicating to partner desire to have or not have sex
Measured: Baseline, Post-Intervention (3 Months)
Change in Reproductive Health Beliefs linked to IPV
Change in commonly held sexual and reproductive health beliefs linked to IPV perpetration.
Measured: Baseline, Post-Intervention (3 Months)
Change in Conceptualization of IPV
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.
Measured: Baseline, Post-Intervention (3 Months)
Change in Attitudes toward IPV Acceptability
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.
Measured: Baseline, Post-Intervention (3 Months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start18 Jan 2018
- Primary completion9 Oct 2018
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National AIDS Research Institute, India
- Responsible party
- Principal investigator, Ameeta Kalokhe, Emory University
- Investigators
- Ameeta Kalokhe, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332134
- Sponsor's protocol ID
- IRB00069846
- Status last verified
- Jan 2019
- First submitted
- 2 Nov 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kalokhe AS, Iyer S, Gadhe K, Katendra T, Kolhe A, Rahane G, Stephenson R, Sahay S. A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study. JMIR Form Res. 2021 Feb 1;5(2):e26130. doi: 10.2196/26130.
PubMed 33459278Kalokhe AS, Iyer S, Katendra T, Gadhe K, Kolhe AR, Paranjape A, Del Rio C, Stephenson R, Sahay S. Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic Intervention. JMIR Res Protoc. 2019 Jan 18;8(1):e11533. doi: 10.2196/11533.
PubMed 30664483
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Prevention of Intimate Partner Violence in India
- ClinicalTrials.gov ID
- NCT03332134
- Acronym / sponsor ID
- IRB00069846
- Conditions
- Intimate Partner Violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National AIDS Research Institute, India
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 9 Oct 2018 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Married Couple Dyad | Experimental | Behavioral: Intimate Partner Violence (IPV) Prevention InterventionHusband-wife dyads will receive the intimate partner violence (IPV) intervention program over the course of six weeks. |
| Control Group | No intervention | –Husband-wife dyads in the control group will not receive an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Pregnant in third trimester of pregnancy
- Women who respond affirmatively to either a physical and/or sexual IPV item on the IFVCS short form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intimate Partner Violence (IPV) Prevention InterventionThe 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. | Behavioural | Married Couple Dyad |
Primary outcome
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.
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.
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.
8 secondary outcomes
Change in Time Spent Together
Time frame: Baseline, Post-Intervention (3 Months)
Change in Self-esteem
Time frame: Baseline, Post-Intervention (3 Months)
Change in Communication Skills
Time frame: Baseline, Post-Intervention (3 Months)
Change in Conflict Negotiation Skills
Time frame: Baseline, Post-Intervention (3 Months)
Change in Sexual Communication Skills
Time frame: Baseline, Post-Intervention (3 Months)
Change in Reproductive Health Beliefs linked to IPV
Time frame: Baseline, Post-Intervention (3 Months)
Change in Conceptualization of IPV
Time frame: Baseline, Post-Intervention (3 Months)
Change in Attitudes toward IPV Acceptability
Time frame: Baseline, Post-Intervention (3 Months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 33459278Kalokhe AS, Iyer S, Gadhe K, Katendra T, Kolhe A, Rahane G, Stephenson R, Sahay S. A Couples-Based Intervention (Ghya Bharari Ekatra) for the Primary Prevention of Intimate Partner Violence in India: Pilot Feasibility and Acceptability Study. JMIR Form Res. 2021 Feb 1;5(2):e26130. doi: 10.2196/26130.
- Derived from this study: PubMed 30664483Kalokhe AS, Iyer S, Katendra T, Gadhe K, Kolhe AR, Paranjape A, Del Rio C, Stephenson R, Sahay S. Primary Prevention of Intimate Partner Violence Among Recently Married Dyads Residing in the Slums of Pune, India: Development and Rationale for a Dyadic Intervention. JMIR Res Protoc. 2019 Jan 18;8(1):e11533. doi: 10.2196/11533.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ameeta Kalokhe, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intimate Partner Violence (IPV) Prevention Intervention in people with Intimate Partner Violence, run by Emory University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IPV Intervention Acceptability (time frame: Duration of Study (Up to 3 Months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019.