Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2024-03-01

Brief Summary

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The goal of this clinical trial is to test the feasibility and acceptability and compare outcomes of a trauma-informed prenatal intervention (TPI) in pregnant Black women with childhood adversity. TPI participants will receive four weekly individual virtual sessions of motivational interviewing to promote self-efficacy and mental wellness skills to enhance self-awareness and self-regulation. TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities.

* With the assistance of a trained facilitator, participants will be guided to identify a specific goal related to the behavior they want to change.
* Behavior change goals will be individualized to create a change plan that reinforces resilience-based coping, accountability, and self-care rewards.
* Participants will learn to apply mental wellness skills to enhance regulation and to facilitate awareness of internal cues related to desire, motivation, and individual responses to stress.

Researchers will compare usual prenatal care plus TPI versus usual prenatal care plus prenatal education to see if TPI reduces psychological (e.g., depression, anxiety, and perceived stress), and socio-emotional (e.g., mood, resilience, social support), and prenatal health behaviors.

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Detailed Description

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The goal of this research to reduce the impact of maternal adverse childhood experiences (ACEs) on perinatal mental and psychosocial health by providing the necessary tools for the development of healthy coping practices. The purpose of this proposal is to conduct Phase II preliminary testing of an individually randomized pilot trial (N=40) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., stress and anxiety) and socio-emotional (e.g., mood, resilience, social support) functioning and prenatal health behaviors of those allocated to either a trauma-informed prenatal intervention (TPI) (n=15) or the control group, e.g., prenatal education arm, (n=15). Forty adult, pregnant women receiving prenatal care at one large Federally Qualified Health Center will be enrolled between 10-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to facilitate behavior change and mental wellness skills to promote self-regulation. Control group participants will receive four weekly (30-60 minutes) individual online sessions of prenatal education. Patient-reported outcome measures will be interview-administered at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. A trauma-informed approach within prenatal care services may help reduce maternal distress and its consequences, and, subsequently, lessen the risk for the negative impact of ACEs on maternal and child health. Findings from this study will inform a larger efficacy trial of TPI to improve perinatal mental health among pregnant women.

Conditions

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Maternal Psychological Distress Perinatal Depression Self-Regulation, Emotion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The intervention consists of four weekly individual sessions. In Step One, participants identify ways of coping with stress and create a behavior change plan with measurable goals. An initial 1-hour semi-structured interview provides an opportunity to self-assess motivation to change a health behavior. Step Two facilitates a behavior plan assisting participants to identify a measurable goal, barriers to achieving their goal, strategies to mitigate triggers, social supports, and progress rewards. Sessions 2-4 include a 10-minute check-in to assess the status of targeted behaviors, troubleshoot potential barriers, modify the plan, and reinforce progress followed up with 20-minutes of practicing mindfulness. In Step Three, participants will learn and practice mental wellness skills (e.g., tracking, resourcing, grounding, gesturing), which can be applied to changing a behavior.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trauma Informed Prenatal Intervention (TPI)

The experimental arm consists of four weekly, individual (30-60 minute) sessions via Zoom with a trained behavioral health scientist and therapist facilitating motivational interviewing focused on behavior change and mental wellness skills.

Group Type EXPERIMENTAL

Trauma Informed Prenatal Intervention (TPI)

Intervention Type BEHAVIORAL

TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. In the experimental group, a research staff member will meet with participants and help them to identify a health behavior they want to change, explore the pros and cons of making a change, create a behavior change plan, and learn several mindfulness meditation techniques. The facilitator will check-in with the participants about their behavior change plan in the subsequent sessions regarding progress made, barriers encountered, and changes in the plan and/or goal going forward. Participants will be instructed to implement an at-home mental wellness skills and provided with a tracking log to report the frequency and dose of daily/weekly practice.

Prenatal Education Topics

The active comparator arm consists of four weekly, individual (30-45 minute) sessions via Zoom with a research staff member delivering prenatal education topics consisting of lecture (power point slides) and video.

Group Type ACTIVE_COMPARATOR

Prenatal Education Topics

Intervention Type OTHER

In the control group, a research staff member will provide participants with four different weekly prenatal education topics, including information on prenatal care, labor and delivery, postpartum care, and newborn care.

Interventions

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Trauma Informed Prenatal Intervention (TPI)

TPI is designed to foster behavior change and health coping by enhancing knowledge, beliefs, regulation skills and abilities. In the experimental group, a research staff member will meet with participants and help them to identify a health behavior they want to change, explore the pros and cons of making a change, create a behavior change plan, and learn several mindfulness meditation techniques. The facilitator will check-in with the participants about their behavior change plan in the subsequent sessions regarding progress made, barriers encountered, and changes in the plan and/or goal going forward. Participants will be instructed to implement an at-home mental wellness skills and provided with a tracking log to report the frequency and dose of daily/weekly practice.

Intervention Type BEHAVIORAL

Prenatal Education Topics

In the control group, a research staff member will provide participants with four different weekly prenatal education topics, including information on prenatal care, labor and delivery, postpartum care, and newborn care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* receiving prenatal care at University of Illinois Health \& Hospital System
* age \>/= 18 years
* English-speaking
* 10-24 weeks gestation
* able to attend four sessions
* owner of a smart phone and access to internet

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes