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

Reducing Stress-Sensitive Problems Among Pregnant Black Women With Childhood Adversity: A Pilot Randomized Controlled Trial of Motivational Interviewing and Mental Wellness Skills

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 improves socio-emotional (e.g., behavioral activation, negative mood regulation, and mindfulness), and prenatal health behaviors.

Study Overview

• Status: Recruiting
• Conditions: Health Behavior; Childhood Trauma; Maternal Psychological Distress
• Intervention / Treatment: Other: Prenatal Education Topics; Behavioral: Trauma Informed Prenatal Intervention (TPI)

Detailed Description

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=30) examining feasibility, acceptability, and compare initial estimates of the effects of the primary outcome of depression and secondary outcomes of psychological (e.g., perceived stress, anxiety) and socio-emotional (e.g., behavioral activation, negative mood regulation, mindfulness) 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). Thirty adult, pregnant Black women with >/=2 ACEs receiving prenatal care at one large Federally Qualified Health Center (FQHC), Mile Square, will be enrolled during the second trimester between 12-24 weeks gestation. TPI participants will receive four weekly (30-60 minute) individual online sessions of motivational interviewing to promote self-efficacy and guided mindfulness practice to enhance self-awareness. Patient-reported outcome measures will be collected online at baseline, 4- and 12-weeks post-randomization, and 6-weeks postpartum. The broader implementation potential of identifying, assessing, and addressing ACEs impact in Mile Square Health Center will be explored using interview-administered surveys. 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 maternal mental and psychosocial health among pregnant Black women with maternal ACEs.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellen Goldstein, PhD; Phone Number: (312) 355-2790; Email: elleng@uic.edu
• Study Contact Backup: Name: Mary Dawn Koenig, PhD, RN, CNM; Email: marydh@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60608
      • Recruiting
      • Mile Square Health Center
      • Contact: Jude Fleurimont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• receiving prenatal care at Mile Square Health Center or University of Illinois Health
• age >/= 18 years
• >/= 2 adverse childhood experiences
• Black race
• English-speaking
• 10-24 weeks gestation
• able to attend four sessions
• owner of a smart phone and access to internet

Exclusion Criteria: inability to reliably or safely participate in the study due to self-reported serious or persistent mental health disorder (e.g., schizophrenia or bipolar disorder), which could also interfere with study adherence.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trauma Informed Prenatal Intervention (TPI); The experimental arm consists of four weekly, individual (45-60 minute) sessions via Zoom with a research staff member facilitating motivational interviewing focused on behavior change and mindfulness awareness practice.	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.
Active Comparator: Prenatal Education Topics; The active comparator arm consists of four weekly, individual (30-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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Edinburgh Postnatal Depression Scale at 6-weeks postnatal	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Generalized Anxiety Disorder Scale at 6-weeks postnatal	Generalized Anxiety Disorder Scale (range: 0-21) is a 7-item scale that assesses the frequency of excessive, uncontrollable worry in the past two-weeks in which a higher score indicates a worse outcome regarding life events or activities in which a higher score signifies a worse outcome.	6-weeks postnatal
Change in Perceived Stress Scale at 6-weeks postnatal	The Perceived Stress Scale (range: 0-40) is a 10-item scale that assesses the frequency of stressful thoughts and feelings in the last one month in which a higher score indicates a worse outcome.	6-weeks postnatal
Change in Behavioral Activation Scale at 6-weeks postnatal	The Behavioral Activation Scale (range: 0-54) is a 9-item scale that assesses avoidance or engagement in goal-directed activity and pleasant behaviors during the past one week in which a higher score indicates a better outcome.	6-weeks postnatal
Negative Mood Regulation Short Form Scale at 6-weeks postnatal	The Negative Mood Regulation Scale (range: 15-75) is a 15-item scale that assesses the capacity for calming and soothing emotions when one is upset in which a higher score indicates a better outcome.	6-weeks postnatal
Change in Five Facet Mindfulness Questionnaire at 6-weeks postnatal	The Five Facet Mindfulness Questionnaire (range: 15-75) is a 15-item scale that assesses the frequency of a general tendency to be self-aware and mindful in everyday life in which a higher score indicates a better outcome.	6-weeks postpartum
Change in Prenatal Health Behaviors at 6-weeks postnatal	The Prenatal Health Behaviors Scale (range: 0-96) is a 24-item scale that assesses the frequency of the use of prenatal health behaviors, including smoking, alcohol, drugs, food, vitamins, physical activity, sleep, etc in which a higher score signifies a worse outcome.	6-weeks postnatal

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Prenatal Distress at 12-weeks post-randomization	The Prenatal Distress Scale (range: 0-35) is an 18-item scale that assesses the things that are worrisome or bothersome about their pregnancy in which a higher score indicates a worse outcome.	12-weeks post-randomization
Treatment Acceptability and Preferences Scale	The Treatment Acceptability and Preferences Scale (range: 0-36) is a 9-item scale that evaluates the effectiveness, acceptability, and suitability of the intervention in which a higher score indicates a better outcome.	4-weeks post-randomization
Change in Connor-Davidson Resilience Scale at 4-weeks post-randomization	The Connor-Davidson Resilience Scale (range: 0-40) is a 10-item scale that assesses the ability to cope with adversity over the last one month in which a higher score indicates a better outcome.	4-weeks post-randomization
Expanded Adverse Childhood Experiences	The Expanded Adverse Childhood Experiences survey (range: 0-21) is a 21-item questionnaire that assesses childhood adversity prior to age 18 years in which a higher score indicates a worse outcome.	Baseline
Benevolent Childhood Experiences	The Benevolent Childhood Experiences survey (range: 0-10) is a 10-item questionnaire that assesses positive childhood experiences during your first 18 years of life in which a higher score indicates a worse outcome.	Baseline
Everyday Discrimination Scale	The Everyday Discrimination Scale (range: 0-50) assesses the frequency of negative experiences as a result of one's race, ethnicity, or skin color in which a higher score indicates a worse outcome. The EDS was developed as a subjective measure to capture self-reported frequency of routine, relatively subtle discriminatory experiences in everyday social situations. Responses are typically coded on a 6-point Likert scale ranging from 'never' to 'almost everyday'.	Baseline
Social Determinants of Health Assessment Tool	The Social Determinants of Health Assessment Tool is a 10-item survey (0-10) that helps to identify health-related social needs (e.g., food, housing/utilities, transportation, and personal safety.	Baseline
Change in Posttraumatic Stress Disorder Checklist - Civilian at 6-week postnatal	Posttraumatic Stress Disorder Checklist - Civilian is a 17-item survey (range: 17-85) in which respondents indicate how much they have been bothered by each PTSD symptom over the past month using a 5-point scale ranging from 1 = not at all to 5 = extremely in which a higher score indicates a better outcome.	6-weeks postnatal
Change in General Self-Efficacy Scale at 6-weeks postnatal	The General Self-Efficacy Scale (range: 10-50) assesses confidence in one's ability to successfully perform specific tasks or behaviors in which a higher score indicates a better outcome.	6-weeks postnatal

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Ellen Goldstein, PhD, MFT, University of Illinois Chicago

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: December 1, 2022
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: 2022-1175; U54MD012523 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No