NCT05718479

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

Completed NA Last updated 20 March 2025

What this trial tests

NA trial testing Trauma Informed Prenatal Intervention (TPI) in Maternal Psychological Distress in 40 participants. Completed in 1 March 2024.

Timeline

14 February 2023

Primary endpoint
1 March 2024

1 March 2024

Quick facts

Lead sponsor	University of Illinois at Chicago
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	14 February 2023
Primary completion	1 March 2024
Estimated completion	1 March 2024
Sites	1 location across United States

Drugs / interventions tested

• Trauma Informed Prenatal Intervention (TPI)
• Prenatal Education Topics

Conditions studied

• Maternal Psychological Distress — all drugs for Maternal Psychological Distress →
• Perinatal Depression — all drugs for Perinatal Depression →
• Self-Regulation, Emotion — all drugs for Self-Regulation, Emotion →

Sponsor

University of Illinois at Chicago

Who can join

18 and older, female only, with Maternal Psychological Distress or Perinatal Depression. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring trauma-informed prenatal care preferences through diverse pregnant voices.
   Itani MS, Shankar M, Goldstein E. · · 2025 · cited 4× · PMID 40148939 · DOI 10.1186/s12913-025-12519-w
2. A Pilot Randomized Controlled Trial of a Multimodal Wellness Intervention for Perinatal Mental Health.
   Goldstein E, Keita M, Koomson C, Tintle N, et al · · 2025 · cited 1× · PMID 40207735 · DOI 10.1111/jmwh.13754