Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01661504
Other study ID # 1202009793
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2013
Est. completion date December 2014

Study information

Verified date September 2021
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The overall goal of this proposed study is to develop the state of knowledge in the area of gender-based violence and reproductive health by conducting a randomized controlled trial to improve the health care provider's capacity to screen for intimate partner violence and to mitigate associated risk among women health clinic patrons of reproductive age (ages18-44) with recent experiences of physical or sexual partner violence in Mexico City and its surrounding area. The specific research objectives are as follows: 1. To increase mid-level health care providers' capacity to identify Intimate Partner Violence (IPV) and assist women with risk mitigation 2. Utilizing a randomized controlled trial, to assess the impact of an enhanced health care worker screening and counselling program on (a) past year severe IPV (sexual or physical), including severe IPV; (b) reproductive coercion (c) use of community-based resources and safety planning; and (d) quality of life; versus minimum standard of care 3. To qualitatively examine which programmatic components may serve as mechanisms for observed changes stated in the second objective 4. To synthesize study findings and a) create recommendations for clinic-based intervention programs to address IPV in low and middle income countries and b) disseminate information as reports, presentation, and peer-reviewed publications


Recruitment information / eligibility

Status Completed
Enrollment 959
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria: - Ages 18-44 - Currently in heterosexual relationship with a male partner - Responds in affirmative to past year sexual or physical violence Exclusion Criteria: - Cognitive impairment (slurred speech, inability to follow directions) - Seeking treatment for life threatening emergency care - Intends to relocate within 2 years.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Integrated Screening
The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions

Locations

Country Name City State
Mexico Health Clinics associated with Ministry of Health in Mexico City Mexico City

Sponsors (3)

Lead Sponsor Collaborator
Yale University Innovations for Poverty Action, Mexican National Institute of Public Health

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Intimate Partner Violence Victimization from Baseline Participants will be followed up at 3 months and at 15 months post-baseline to assess intimate partner violence victimization as measured by an adapted Conflict Tactics Scale - 2. This will allow for a 12 month follow-up from the booster counseling session in the intervention group which occurs at 3 months post-baseline. 12 months
Secondary Change in Quality of Life Score past month
Secondary Change in Use of Community Resources Adapted Community Resources Checklist 12 months
Secondary Change in Safety Planning Adapted Safety Behavior Checklist 12 Months
Secondary Change in Reproductive Coercion 12 months
See also
  Status Clinical Trial Phase
Completed NCT03037749 - Over-arousal as a Mechanism Between Alcohol and Intimate Partner Violence N/A
Completed NCT02606344 - Effect of a Micro-finance-based Intervention for the Prevention of Intimate-partner Violence and HIV N/A
Completed NCT03482687 - It's Your Game: An Innovative Approach to Preventing Teen Dating Violence N/A
Active, not recruiting NCT00847548 - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting N/A
Completed NCT01207258 - Brief Intervention for Problem Drinking and Partner Violence Phase 2
Completed NCT00983593 - A Randomized Clinical Study of a Mind-Body Approach to Domestic Violence Offender Treatment N/A
Completed NCT01621334 - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use Phase 1
Completed NCT01803932 - Evaluation of a Male-focused Intervention to Prevent Intimate Partner Violence in a Conflict-affected Setting N/A
Completed NCT00289939 - Reducing HIV & Domestic Violence Risk in Women Offenders Phase 3
Completed NCT05598697 - Economic Evaluation of the MEWE Intervention N/A
Not yet recruiting NCT03672942 - Communication Skills vs. Mindfulness for IPV N/A
Completed NCT03883932 - Fatherhood Focused Family Violence Education Program N/A
Completed NCT05129501 - The Impact of an Adapted Version of the Strengthening Families Program on IPV Among Caregivers and ACEs Among Children N/A
Enrolling by invitation NCT05139069 - Using Implementation Science to Increase Pre-Exposure Prophylaxis Uptake Among African American Women N/A
Recruiting NCT03198429 - Cluster RCT of Embedded Parenting Intervention to Prevent Recurrence and Reduce Impairment in Young Children Exposed to Domestic Violence N/A
Completed NCT04125251 - Men Engagement in Women Empowerment for Improving Maternal Mental Health Through Cash Transfer and Life Skills Building N/A
Active, not recruiting NCT03236948 - RCT of the Effectiveness of the WfWI Intervention in Afghanistan Phase 3
Completed NCT02258841 - Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence N/A
Completed NCT01958554 - Impact of an Integrated Intervention on Mental Health in Survivors of Intimate Partner Violence Phase 2
Completed NCT01688427 - Perinatal Nurse Home Visiting Enhanced With mHealth Technology N/A

External Links