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

Summary

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.

Conditions

• Maternal Psychological Distress
• Perinatal Depression
• Self-Regulation, Emotion

Interventions

BEHAVIORAL

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.

OTHER

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.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• University of Illinois at Chicago

  lead OTHER

Principal Investigators

• Ellen Goldstein, PhD, MFT · University of Illinois Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-14

Primary Completion

2024-03-01

Completion

2024-03-01

Countries

• United States

Study Locations