Clinical trial NCT04068662: Intervention for IPV-exposed Pregnant Women
Official title: Intervening During the Prenatal Period With Women Exposed to Intimate Partner Violence to Improve Maternal Functioning and Infant Adjustment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postpartum Depression
Posttraumatic Stress Disorder
Infant Behavior
Violence
Parenting
Keywords: intimate partner violence
resilience, psychological
Lead sponsor: University of Notre Dame
Sponsor class: OTHER
Collaborators: name: University of Memphis
First posted: 2019-08-28
Enrollment: 460
Sex: FEMALE
Minimum age (years): 3
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the Pregnant Moms' Empowerment Program or an active control group. Members of the active control group participate in a non-directive support group with contact equivalent time to the Pregnant Moms' Empowerment Program (10 hrs).
Primary purpose: TREATMENT

Brief summary: The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy.

The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older.

The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).

Detailed description: The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site (n=115 at each site for a total of N=230 mothers). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the PMEP. The expected duration of the study for each participant is approximately 1.75 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the current study is to determine if the PMEP has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development, as compared to women's participation in a contact-equivalent control group. This objective will be evaluated usin ga multi-site randomized clinical trial design. Participants (N=230) will be equally randomized into study arms. Eligible women include those who are currently pregnant, who have experienced IPV in the past year, are age 16 or older, and are currently between 10 and 30 weeks pregnant. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with postpartum assessments somewhat longer than prenatal assessments due to the addition of the infant developmental assessment. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Treatment sessions will be 2 hrs in duration. Women in the PMEP will complete a structured set of sessions: (1) safety planning, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, (5) positive parenting. Women in the AC will participate in facilitated discussions on a topic identified by the group. All sessions will be audiorecorded so that treatment fidelity can be evaluated (for PMEP) and content overlap can be identified (for AC).

Eligibility criteria: Inclusion Criteria:

* currently pregnant (primi or multiparous)
* experienced intimate partner violence within the past year
* English speaking
* age 16 or older
* between 10-30 weeks pregnant

Exclusion Criteria:

* fails to meet inclusion criteria
* unavailable or unwilling to participate in core study components, including groups

Primary outcomes:
measure: Change in posttraumatic stress symptoms from baseline to post-treatment
timeFrame: posttreatment
measure: Change in posttraumatic stress symptoms from baseline to 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in posttraumatic stress symptoms from baseline to 12-months postpartum
timeFrame: 12-months postpartum
measure: Change in depressed mood from baseline to posttreatment
timeFrame: posttreatment
measure: Change in depressed mood from baseline to 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in depressed mood from baseline to 12-months postpartum
timeFrame: 12-months postpartum
measure: Change in resilience from baseline to posttreatment
timeFrame: posttreatment
measure: Change in resilience from baseline to 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in resilience from baseline to 12-months postpartum
timeFrame: 12-months postpartum
measure: Maternal Sensitivity at infant age 3 months
timeFrame: 3-months postpartum
measure: Maternal Sensitivity at infant age 12 months
timeFrame: 12-months postpartum
measure: Intimate Partner Violence at posttreatment
timeFrame: posttreatment
measure: Intimate Partner Violence at 3-months postpartum
timeFrame: 3-months postpartum
measure: Intimate Partner Violence at 12-months postpartum
timeFrame: 12-months postpartum
measure: Infant Development at 3 months of age
timeFrame: 3-months
measure: Infant Development at 12 months of age
timeFrame: 12-months
measure: Infant Regulation at 3 months of age
timeFrame: 3-months
measure: Infant Regulation at 12 months of age
timeFrame: 12-months
Secondary outcomes:
measure: Change in social support from baseline to posttreatment
timeFrame: posttreatment
measure: Change in social support from baseline to 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in social support from baseline to 12-months postpartum
timeFrame: 12-months postpartum
measure: Change in empowerment from baseline to posttreatment
timeFrame: posttreatment
measure: Change in empowerment from baseline to 3-months postpartum
timeFrame: 3-months postpartum
measure: Change in empowerment from baseline to 12-months postpartum
timeFrame: 12-months postpartum
Other outcomes:
Locations:
city: Notre Dame
country: United States
facility: University of Notre Dame
state: Indiana
city: Memphis
country: United States
facility: University of Memphis
state: Tennessee
Study officials:
References: