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

NCT05718479 | Completed

• 2 other identifiers: 2022-1175U54MD012523
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Edinburgh Postnatal Depression Scale at 2-months post-intervention

  The Edinburgh Postnatal Depression Scale (range: 0-30) is a 10-item scale is a pregnancy and/or postpartum depression screen that assesses different emotions in the past seven days in which a higher score indicates a worse outcome.

  6-weeks postnatal

Secondary Outcomes (7)

• Change in Generalized Anxiety Disorder Scale at 2-months post-intervention

  6-weeks postnatal

• Change in Perceived Stress Scale at 2-months post-intervention

  6-weeks postnatal

• Change in Behavioral Activation Scale at 2-months post-intervention

  6-weeks postnatal

• Negative Mood Regulation Short Form Scale at 2-months post-intervention

  6-weeks postnatal

• Connor Davidson Resilience Scale at 2-months post-intervention

  6-weeks postpartum

Other Outcomes (6)

• Prenatal Distress at 2-months post-intervention

  2-months post-intervention

• Treatment Acceptability and Preferences Scale at post-intervention

  4-weeks post-randomization

• Expanded Adverse Childhood Experiences at baseline

  Baseline

Study Arms (2)

Trauma Informed Prenatal Intervention (TPI)

EXPERIMENTAL

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.

Behavioral: Trauma Informed Prenatal Intervention (TPI)

Prenatal Education Topics

ACTIVE COMPARATOR

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.

Other: Prenatal Education Topics

Interventions

Trauma Informed Prenatal Intervention (TPI) 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.

Trauma Informed Prenatal Intervention (TPI)

Prenatal Education Topics 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.

Prenatal Education Topics

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant people
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of Illinois Health & Hospital System

Chicago, Illinois, 60608, United States

Location

Related Publications (2)

• Goldstein E, Keita M, Koomson C, Tintle N, Adlam K, Farah E, Koenig MD. A Pilot Randomized Controlled Trial of a Multimodal Wellness Intervention for Perinatal Mental Health. J Midwifery Womens Health. 2025 May-Jun;70(3):442-451. doi: 10.1111/jmwh.13754. Epub 2025 Apr 10.

  PMID: 40207735 DERIVED

• Itani MS, Shankar M, Goldstein E. Exploring trauma-informed prenatal care preferences through diverse pregnant voices. BMC Health Serv Res. 2025 Mar 27;25(1):452. doi: 10.1186/s12913-025-12519-w.

  PMID: 40148939 DERIVED

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Ellen Goldstein, PhD, MFT

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2022
• First Posted: February 8, 2023
• Study Start: February 14, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

US (1)