Dil Mil (Hearts Together)

NCT01337778 | Completed Phase 2 DMC

• 1 other identifier: 1R21HD062821-01A1
• Study Type: interventional
• Target: 539
• Locations: 1 country
• Sites: 1

Brief Summary

A growing body of research indicates that gender-based violence (GBV) is a major global public health challenge. Yet, there is a dearth of evidence to guide program planning and policy-making efforts to reduce GBV. Our study will evaluate the feasibility, safety, and potential effectiveness of an innovative women's empowerment intervention to reduce GBV and related adverse health outcomes. It is expected that the study findings will provide evidence to determine if a phase 3 effectiveness trial is merited and advance the science underlying GBV prevention.

Conditions

Gender Based Violence; Women's Health

Keywords

gender based violence; maternal and child health; women; India

Outcome Measures

Primary Outcomes (2)

• Incident Gender-Based Violence (GBV)

  Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members

  3 months postpartum

• Incident GBV

  Measured in terms of any physical, psychological, or sexual violence perpetrated by husbands, MILs, or other family members

  6 months postpartum

Secondary Outcomes (8)

• Safety

  3 months postpartum

• Safety

  6 months postpartum

• Feasibility

  3 months postpartum

• Feasibility

  6 months postpartum

• Daughter-in-Laws' (DILs') Knowledge

  3 months postpartum

Study Arms (2)

Primary Care for DILs

ACTIVE COMPARATOR

Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced gender-based violence. A comprehensive health examination for mothers-in-law will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks.

Behavioral: Primary care for Daughters-in-Law

Standard Care plus Dil Mil Intervention

EXPERIMENTAL

The Dil Mil intervention will be implemented during the second and third trimesters of the daughter-in-law's (DILs) pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with mothers-in-law (MILs), and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce gender-based violence (GBV) and protect and promote their family's health.

Behavioral: The Dil Mil Intervention

Interventions

Primary care for Daughters-in-Law BEHAVIORAL

Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced GBV.A comprehensive health examination for MILs will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks.

Primary Care for DILs

The Dil Mil Intervention BEHAVIORAL

The Dil Mil intervention will be implemented during the second and third trimesters of the DILs' pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with MILs, and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. Participants are encouraged to critically analyze their relationships and to develop and implement responses appropriate to their families and communities. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce GBV and protect and promote their family's health.

Standard Care plus Dil Mil Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Daughters-in-Law:
• married
• age 18 years to 30 years
• have ever experienced physical, psychological, or sexual violence perpetrated by husbands, mothers-in-law, or other marital family members
• pregnant and in the first or second trimester
• Kannada or Tamil speaking
• able and willing to provide consent
• able and willing to refer their mother-in-law for study participation
• Mothers-in-Law:
• Kannada or Tamil speaking
• able and willing to give informed consent to participate
• confirm that they are the mother-in-law of a daughter-in-law who is being recruited.

You may not qualify if:

• planning to move from the area before the daughter-in-law completes 6 months postpartum
• cognitively impaired
• major depression or dementia

Sponsors & Collaborators

• RTI International: lead
• St. John's Research Institute: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

St. John's Research Institute, St. John's National Academy of Health Sciences

Kormangala, Bangalore, 560034, India

Location

Related Publications (1)

• Krishnan S, Subbiah K, Chandra P, Srinivasan K. Minimizing risks and monitoring safety of an antenatal care intervention to mitigate domestic violence among young Indian women: The Dil Mil trial. BMC Public Health. 2012 Nov 1;12:943. doi: 10.1186/1471-2458-12-943.

  PMID: 23116189 DERIVED

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Suneeta Krishnan, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 19, 2011
• Study Start: August 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: October 1, 2013
• Last Updated: November 4, 2013

Record last verified: 2013-11

Locations

IN (1)